Advanced Solid Tumors
Conditions
Brief summary
This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and activity of FPT155 as monotherapy in patients with advanced solid tumors.
Detailed description
This Phase 1 study is comprised of dose escalation and cohort expansions for FPT155 monotherapy and for FPT155 in combination with pembrolizumab. Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; combination dose escalation uses a standard 3+3 design. Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.
Interventions
BIOLOGICALFPT155
A soluble CD80 fusion protein
BIOLOGICALpembrolizumab
An anti-PD1 antibody
Sponsors
Five Prime Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two arm trial with multiple cohorts
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed solid tumors (except primary central nervous system tumors). For patients enrolled for treatment with FPT155+pembrolizumab: histologically confirmed non-small cell lung cancer not eligible for curative therapy. * Disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments * All patients must have at least one measurable lesion at baseline according to RECIST v1.1 * Availability of archival tumor tissue and consent to provide archival tumor for retrospective biomarker analysis, or consent to undergo a fresh tumor biopsy during screening * For patients participating in cohort expansions: consent to undergo a mandatory fresh tumor biopsy during screening and on treatment * ECOG performance status of 0 or 1 * Prior radiotherapy must be completed at least 2 weeks before first dose of study treatment administration. No radiopharmaceuticals (eg, strontium, samarium) within 8 weeks before first dose of study treatment administration. * Prior surgery that requires general anesthesia must be completed at least 14 days before first dose of study treatment * Adequate bone marrow, liver and kidney function
Exclusion criteria
* Uncontrolled or significant cardiac disease * Any uncontrolled medical condition or psychiatric disorder including infection, autoimmune disease, bleeding disorder or symptomatic involvement of the central nervous system * Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 28 days or ≤ 5 half-lives (whichever is shorter) * Patients who discontinue prior immune-modulating therapies (including regimens containing an immune agonist or a PD-L1/PD-1 antagonist) due to toxicity or have received treatment within 5 half lives or 90 days * Pregnancy or breastfeeding * For patients participating in cohort expansion: Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination | TEAE was defined as an adverse event (AE) that was not present prior to the start date of study drug or was worsened during treatment and 100 days after last dose of treatment. An AE that was present at treatment initiation but resolved and then reappeared and the event severity increase while the participant was on treatment is also a TEAE. A severe AE (SAE) is defined as any untoward medical occurrence that at any dose: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, and is a congenital anomaly/birth defect. AEs were graded 1 (mild)-5 (fatal AE) according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03. |
| Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days | DLTs ware defined as any of the events that occurred during the first 28 days of treatment and were assessed by the Clinical Research Coordinator (CRC) as related to FPT155. |
| Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs | Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks. | Represents the number of participants who had discontinuation of FPT155 dosing due to AEs. |
| Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs | Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks. | Represents the number of participants who had a modification in the dosing schedules of FPT155 due to AEs. |
| Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs | Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks. | Represents the number of participants who had an interruption in the dosing schedules of FPT155 due to AEs. |
| Phase 1a Combination: Number of Participants Who Experienced DLTs | Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days | DLTs ware defined as any of the events that occur during the first 28 days of treatment and are assessed by the CRC as related to FPT155. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Cycle 1 (21-day cycles) Day 1 | Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment. |
| Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1 | Up to approximately 30 months | ORR was defined as the total number of participants with confirmed responses of either complete response (CR) (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm) or partial response (PR) (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1. |
| Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1 | Up to approximately 30 months | DOR was defined as the time from first response (CR \[The disappearance of all target lesions, any pathological lymph nodes {whether target or non-target} or PR \[At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters\] determined by the investigator per RECIST v1.1) that was subsequently confirmed until the onset of progressive disease (DP) (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study \[this includes the baseline sum if that is the smallest on study\]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) or death from any cause, whichever occurred first. |
| Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1 | Up to approximately 30 months | PFS was defined as time from the first dose of study treatment until the first documentation by the investigator of DP (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study \[this includes the baseline sum if that is the smallest on study\]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) per RECIST v1.1 or death from any cause, whichever occurred first. The median was estimated by using the Kaplan-Meier method and corresponding 2-sided 90% CI using Brookmeyer and Crowley methodology. |
| Phase 1b Monotherapy: t1/2 of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
| Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1 | Up to approximately 30 months | DCR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm), PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), or stable disease (SD) (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. In numerical terms, it means a reduction in tumor size that is less than 30% \[which is required for PR\] and an increase in size that is less than 20% \[which is required for PD\]) as determined by the investigator per RECIST v1.1. |
| Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
| Phase 1b Monotherapy: Cmax of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
| Phase 1b Monotherapy: Ctrough of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
| Phase 1b Monotherapy: CL of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
| Phase 1b Monotherapy: Vss of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
| Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Cycle 1 (21-day cycles) Day 1 | Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment. |
| Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to approximately 30 months | ORR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm) or PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1. |
| Phase 1b Monotherapy: AUC0-tau of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
| Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
| Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
| Phase 1a Monotherapy: Clearance (CL) of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
| Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
| Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | — |
Countries
Australia, South Korea
Participant flow
Recruitment details
Participants with advanced solid tumours were recruited across 15 centers in Australia and South Korea from October 2018 to August 2021.
Pre-assignment details
Participants received escalating doses of FTP155 until the recommended dose (RD) was established in Phase 1a monotherapy. Phase 1b monotherapy involved dividing participants into 4 tumor-specific cohorts, treated at the RD. In Phase 1a combination therapy, participants with non-small cell lung cancer were split into 3 cohorts and given FTP155 below the RD with Pembrolizumab. Both Phase 1b monotherapy and Phase 1a combination were initiated but not completed due to the study's closure.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1a Monotherapy: FPT155 Dose A Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified. | 1 |
| Phase 1a Monotherapy: FPT155 Dose B Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 1 |
| Phase 1a Monotherapy: FPT155 Dose C Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 2 |
| Phase 1a Monotherapy: FPT155 Dose D Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 1 |
| Phase 1a Monotherapy: FPT155 Dose E Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 4 |
| Phase 1a Monotherapy: FPT155 Dose F Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 3 |
| Phase 1a Monotherapy: FPT155 Dose G Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 3 |
| Phase 1a Monotherapy: FPT155 Dose H Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 3 |
| Phase 1a Monotherapy: FPT155 Dose I Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 7 |
| Phase 1a Monotherapy: FPT155 Dose J Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 10 |
| Phase 1a Monotherapy: FPT155 Dose K Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 20 |
| Phase 1a Monotherapy: FPT155 Dose L Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 6 |
| Phase 1b Monotherapy: 1bM1 FPT155 Dose K Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). | 1 |
| Phase 1b Monotherapy: 1bM2 FPT155 Dose K Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). | 5 |
| Phase 1b Monotherapy: 1bM3 FPT155 Dose K Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). | 3 |
| Phase 1b Monotherapy: 1bM4 FPT155 Dose K Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K). | 1 |
| Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab. | 3 |
| Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab. | 3 |
| Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab. | 3 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 1 | 1 | 2 | 0 | 1 | 0 | 3 | 2 | 4 | 1 | 0 | 2 | 1 | 0 | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Missing end of study status | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Other | 0 | 1 | 1 | 0 | 2 | 1 | 2 | 1 | 1 | 4 | 4 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 1 | 2 | 9 | 2 | 1 | 3 | 2 | 0 | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: FPT155 Dose L | Phase 1b Monotherapy: 1bM1 FPT155 Dose K | Phase 1b Monotherapy: 1bM2 FPT155 Dose K | Phase 1b Monotherapy: 1bM3 FPT155 Dose K | Phase 1b Monotherapy: 1bM4 FPT155 Dose K | Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg | Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg | Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 53 years | 61 years | 65.5 years STANDARD_DEVIATION 10.61 | 42 years | 63.5 years STANDARD_DEVIATION 12.61 | 64.3 years STANDARD_DEVIATION 5.13 | 69 years STANDARD_DEVIATION 4.58 | 53 years STANDARD_DEVIATION 7.81 | 57.3 years STANDARD_DEVIATION 16.55 | 58.6 years STANDARD_DEVIATION 7.75 | 60.3 years STANDARD_DEVIATION 12.17 | 59.3 years STANDARD_DEVIATION 14.22 | 64 years | 53.4 years STANDARD_DEVIATION 10.33 | 64.7 years STANDARD_DEVIATION 3.06 | 71 years | 65.3 years STANDARD_DEVIATION 3.06 | 61.0 years STANDARD_DEVIATION 15.13 | 68.7 years STANDARD_DEVIATION 2.52 | 60.4 years STANDARD_DEVIATION 10.95 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants | 12 Participants | 1 Participants | 1 Participants | 5 Participants | 3 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 33 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 9 Participants | 18 Participants | 6 Participants | 1 Participants | 5 Participants | 3 Participants | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 76 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 5 Participants | 7 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 43 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 5 Participants | 5 Participants | 5 Participants | 1 Participants | 5 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 38 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 4 Participants | 5 Participants | 15 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 1 | 0 / 1 | 1 / 2 | 1 / 1 | 2 / 4 | 0 / 3 | 1 / 3 | 0 / 3 | 3 / 7 | 2 / 10 | 4 / 20 | 1 / 6 | 0 / 1 | 2 / 5 | 1 / 3 | 0 / 1 | 1 / 3 | 0 / 3 | 1 / 3 |
| other Total, other adverse events | 0 / 1 | 1 / 1 | 2 / 2 | 1 / 1 | 3 / 4 | 2 / 3 | 3 / 3 | 3 / 3 | 6 / 7 | 10 / 10 | 18 / 20 | 5 / 6 | 1 / 1 | 5 / 5 | 3 / 3 | 1 / 1 | 3 / 3 | 3 / 3 | 2 / 3 |
| serious Total, serious adverse events | 1 / 1 | 0 / 1 | 1 / 2 | 0 / 1 | 1 / 4 | 1 / 3 | 3 / 3 | 0 / 3 | 2 / 7 | 3 / 10 | 10 / 20 | 2 / 6 | 1 / 1 | 0 / 5 | 2 / 3 | 0 / 1 | 2 / 3 | 3 / 3 | 2 / 3 |
Outcome results
Primary
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
TEAE was defined as an adverse event (AE) that was not present prior to the start date of study drug or was worsened during treatment and 100 days after last dose of treatment. An AE that was present at treatment initiation but resolved and then reappeared and the event severity increase while the participant was on treatment is also a TEAE. A severe AE (SAE) is defined as any untoward medical occurrence that at any dose: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, and is a congenital anomaly/birth defect. AEs were graded 1 (mild)-5 (fatal AE) according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03.
Time frame: Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination
Population: Safety population: All participants who received any portion of a least one dose of FPT155.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 4 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 6 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 10 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 6 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 10 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 11 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 20 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 11 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 6 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 6 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 2 Participants |
| Phase 1b Monotherapy: 1bM1 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1b Monotherapy: 1bM1 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 1 Participants |
| Phase 1b Monotherapy: 1bM1 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1b Monotherapy: 1bM1 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 1 Participants |
| Phase 1b Monotherapy: 1bM1 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 1 Participants |
| Phase 1b Monotherapy: 1bM1 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 1 Participants |
| Phase 1b Monotherapy: 1bM2 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1b Monotherapy: 1bM2 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 4 Participants |
| Phase 1b Monotherapy: 1bM2 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 4 Participants |
| Phase 1b Monotherapy: 1bM2 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 5 Participants |
| Phase 1b Monotherapy: 1bM2 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1b Monotherapy: 1bM2 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 0 Participants |
| Phase 1b Monotherapy: 1bM3 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 2 Participants |
| Phase 1b Monotherapy: 1bM3 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 3 Participants |
| Phase 1b Monotherapy: 1bM3 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 2 Participants |
| Phase 1b Monotherapy: 1bM3 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 2 Participants |
| Phase 1b Monotherapy: 1bM3 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 3 Participants |
| Phase 1b Monotherapy: 1bM3 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1b Monotherapy: 1bM4 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 0 Participants |
| Phase 1b Monotherapy: 1bM4 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1b Monotherapy: 1bM4 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 1 Participants |
| Phase 1b Monotherapy: 1bM4 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 0 Participants |
| Phase 1b Monotherapy: 1bM4 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1b Monotherapy: 1bM4 FPT155 Dose K | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 1 Participants |
| Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 3 Participants |
| Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 2 Participants |
| Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 1 Participants |
| Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 2 Participants |
| Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 3 Participants |
| Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 2 Participants |
| Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 0 Participants |
| Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 3 Participants |
| Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 3 Participants |
| Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Grade 3 or Higher | 1 Participants |
| Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Leading to Death | 0 Participants |
| Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 2 Participants |
| Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs Related to FPT155 | 2 Participants |
| Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs Related to FPT155 | 2 Participants |
| Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All SAEs | 2 Participants |
Primary
Phase 1a Combination: Number of Participants Who Experienced DLTs
DLTs ware defined as any of the events that occur during the first 28 days of treatment and are assessed by the CRC as related to FPT155.
Time frame: Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days
Population: DLT-evaluable population: All participants enrolled into Phase 1a dose escalation portion of the study who received at least 1 dose of all assigned study drug(s) and remain on study for the 21-day DLT evaluation period, or who experienced a DLT before clearing the 21-day DLT evaluation interval.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Combination: Number of Participants Who Experienced DLTs | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Combination: Number of Participants Who Experienced DLTs | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Combination: Number of Participants Who Experienced DLTs | Aspartate aminotransferase increased | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Combination: Number of Participants Who Experienced DLTs | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Combination: Number of Participants Who Experienced DLTs | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Combination: Number of Participants Who Experienced DLTs | Aspartate aminotransferase increased | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Combination: Number of Participants Who Experienced DLTs | All DLTs | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Combination: Number of Participants Who Experienced DLTs | Aspartate aminotransferase increased | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Combination: Number of Participants Who Experienced DLTs | Cytokine release syndrome | 1 Participants |
Primary
Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
DLTs ware defined as any of the events that occurred during the first 28 days of treatment and were assessed by the Clinical Research Coordinator (CRC) as related to FPT155.
Time frame: Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days
Population: DLT-evaluable population: All participants enrolled into Phase 1a dose escalation portion of the study who received at least 1 dose of all assigned study drug(s) and remain on study for the 21-day DLT evaluation period, or who experienced a DLT before clearing the 21-day DLT evaluation interval. Study used a 3 + 3 design in the Phase 1a Monotherapy cohorts, from cohort Phase 1a Monotherapy: FPT155 Dose E.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Infusion related reaction | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | All DLTs | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cytokine release syndrome | 1 Participants |
Primary
Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs
Represents the number of participants who had discontinuation of FPT155 dosing due to AEs.
Time frame: Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
Population: Safety population: All participants who received any portion of a least one dose of FPT155.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs | 0 Participants |
Primary
Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs
Represents the number of participants who had an interruption in the dosing schedules of FPT155 due to AEs.
Time frame: Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
Population: Safety population: All participants who received any portion of a least one dose of FPT155.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs | 0 Participants |
Primary
Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs
Represents the number of participants who had a modification in the dosing schedules of FPT155 due to AEs.
Time frame: Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
Population: Safety population: All participants who received any portion of a least one dose of FPT155.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs | 0 Participants |
Secondary
Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm) or PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1.
Time frame: Up to approximately 30 months
Population: Efficacy Population: All participants who received any portion of at least one dose of FPT155.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
Secondary
Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 0.0327 day*ug/mL | — |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 0.1586 day*ug/mL | — |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 1.1365 day*ug/mL | Standard Deviation 0.3622 |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 2.4057 day*ug/mL | — |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 7.6030 day*ug/mL | Standard Deviation 1.70572 |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 20.9191 day*ug/mL | Standard Deviation 2.5834 |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 38.4803 day*ug/mL | Standard Deviation 5.39054 |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 73.3365 day*ug/mL | Standard Deviation 20.47867 |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 165.9985 day*ug/mL | Standard Deviation 38.97415 |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 318.4115 day*ug/mL | Standard Deviation 55.46423 |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 680.4735 day*ug/mL | Standard Deviation 186.74665 |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | 578.2617 day*ug/mL | Standard Deviation 411.33336 |
Secondary
Phase 1a Monotherapy: Clearance (CL) of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Clearance (CL) of FPT155 | 723.1295 mL/day | — |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Clearance (CL) of FPT155 | 816.5143 mL/day | — |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Clearance (CL) of FPT155 | 872.7624 mL/day | Standard Deviation 177.16607 |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Clearance (CL) of FPT155 | 885.2506 mL/day | Standard Deviation 121.93486 |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Clearance (CL) of FPT155 | 1023.0799 mL/day | Standard Deviation 117.05581 |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Clearance (CL) of FPT155 | 921.2589 mL/day | Standard Deviation 387.65387 |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Clearance (CL) of FPT155 | 803.7378 mL/day | Standard Deviation 247.88188 |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Clearance (CL) of FPT155 | 838.7004 mL/day | Standard Deviation 152.86047 |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Clearance (CL) of FPT155 | 822.2251 mL/day | Standard Deviation 308.79493 |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Clearance (CL) of FPT155 | 893.7646 mL/day | — |
Secondary
Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 0.0152 ug/mL | — |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 0.0398 ug/mL | — |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 0.3185 ug/mL | Standard Deviation 0.19304 |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 0.4440 ug/mL | — |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 1.7033 ug/mL | Standard Deviation 0.37909 |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 4.1403 ug/mL | Standard Deviation 1.00748 |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 8.2337 ug/mL | Standard Deviation 0.9991 |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 15.0070 ug/mL | Standard Deviation 1.67983 |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 42.4436 ug/mL | Standard Deviation 14.15113 |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 74.4304 ug/mL | Standard Deviation 12.04634 |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 154.4599 ug/mL | Standard Deviation 36.68364 |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | 236.0270 ug/mL | Standard Deviation 91.32991 |
Secondary
Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment.
Time frame: Cycle 1 (21-day cycles) Day 1
Population: Safety population: All participants who received any portion of a least one dose of FPT155.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 4 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 8 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 8 Participants |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 9 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 6 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 0 Participants |
Secondary
Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | 6.2328 hours | — |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | 5.5142 hours | — |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | 6.2067 hours | Standard Deviation 0.61062 |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | 7.5696 hours | Standard Deviation 0.69887 |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | 5.3969 hours | Standard Deviation 0.40483 |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | 6.7752 hours | Standard Deviation 2.32987 |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | 6.9751 hours | Standard Deviation 1.6227 |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | 5.8128 hours | Standard Deviation 0.80921 |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | 5.9846 hours | Standard Deviation 1.27669 |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | 5.3674 hours | — |
Secondary
Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | 0.0097 ug/mL | — |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | 0.0211 ug/mL | — |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | 0.0670 ug/mL | Standard Deviation 0.03697 |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | 0.2827 ug/mL | Standard Deviation 0.02203 |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | 0.2793 ug/mL | Standard Deviation 0.02875 |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | 0.9813 ug/mL | Standard Deviation 0.72419 |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | 1.8921 ug/mL | Standard Deviation 0.97118 |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | 3.0308 ug/mL | Standard Deviation 0.97789 |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | 8.1734 ug/mL | Standard Deviation 3.7964 |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | 8.0930 ug/mL | — |
Secondary
Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | 5589.3077 mL | — |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | 5945.0963 mL | — |
| Phase 1a Monotherapy: FPT155 Dose E | Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | 6390.4335 mL | Standard Deviation 974.58304 |
| Phase 1a Monotherapy: FPT155 Dose F | Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | 8258.2000 mL | Standard Deviation 1221.67174 |
| Phase 1a Monotherapy: FPT155 Dose G | Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | 7073.7877 mL | Standard Deviation 1555.88613 |
| Phase 1a Monotherapy: FPT155 Dose H | Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | 6994.1331 mL | Standard Deviation 672.03487 |
| Phase 1a Monotherapy: FPT155 Dose I | Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | 6413.4280 mL | Standard Deviation 1007.47809 |
| Phase 1a Monotherapy: FPT155 Dose J | Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | 5958.4609 mL | Standard Deviation 1409.10784 |
| Phase 1a Monotherapy: FPT155 Dose K | Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | 5945.5205 mL | Standard Deviation 1442.85088 |
| Phase 1a Monotherapy: FPT155 Dose L | Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | 6032.9646 mL | — |
Secondary
Phase 1b Monotherapy: AUC0-tau of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: AUC0-tau of FPT155 | 785.6775 day*ug/mL | — |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: AUC0-tau of FPT155 | 874.0402 day*ug/mL | Standard Deviation 236.97475 |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: AUC0-tau of FPT155 | 827.3523 day*ug/mL | Standard Deviation 314.06602 |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1b Monotherapy: AUC0-tau of FPT155 | 245.5924 day*ug/mL | — |
Secondary
Phase 1b Monotherapy: CL of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: CL of FPT155 | 662.0429 mL/day | — |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: CL of FPT155 | 555.8419 mL/day | Standard Deviation 119.27137 |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: CL of FPT155 | 698.3282 mL/day | Standard Deviation 278.39932 |
Secondary
Phase 1b Monotherapy: Cmax of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Cmax of FPT155 | 203.4790 ug/mL | — |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Cmax of FPT155 | 180.9630 ug/mL | Standard Deviation 51.85915 |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Cmax of FPT155 | 214.5727 ug/mL | Standard Deviation 86.57029 |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1b Monotherapy: Cmax of FPT155 | 178.5870 ug/mL | — |
Secondary
Phase 1b Monotherapy: Ctrough of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Ctrough of FPT155 | 1.2920 ug/mL | — |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Ctrough of FPT155 | 11.6875 ug/mL | Standard Deviation 0.77428 |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Ctrough of FPT155 | 5.5480 ug/mL | Standard Deviation 0.58266 |
Secondary
Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1
DCR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm), PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), or stable disease (SD) (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. In numerical terms, it means a reduction in tumor size that is less than 30% \[which is required for PR\] and an increase in size that is less than 20% \[which is required for PD\]) as determined by the investigator per RECIST v1.1.
Time frame: Up to approximately 30 months
Population: Efficacy Population: All participants who received any portion of at least one dose of FPT155.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1 | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1 | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1 | 0 Participants |
Secondary
Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1
DOR was defined as the time from first response (CR \[The disappearance of all target lesions, any pathological lymph nodes {whether target or non-target} or PR \[At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters\] determined by the investigator per RECIST v1.1) that was subsequently confirmed until the onset of progressive disease (DP) (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study \[this includes the baseline sum if that is the smallest on study\]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) or death from any cause, whichever occurred first.
Time frame: Up to approximately 30 months
Population: Efficacy population inclusive of participants with CR or PR.
Secondary
Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment.
Time frame: Cycle 1 (21-day cycles) Day 1
Population: Safety population: All participants who received any portion of a least one dose of FPT155.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 2 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 3 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Negative | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Not Evaluable | 1 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Anti-FPT155 Positive | 0 Participants |
Secondary
Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1
ORR was defined as the total number of participants with confirmed responses of either complete response (CR) (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm) or partial response (PR) (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1.
Time frame: Up to approximately 30 months
Population: Efficacy Population: All participants who received any portion of at least one dose of FPT155.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1 | 0 Participants |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1 | 0 Participants |
Secondary
Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1
PFS was defined as time from the first dose of study treatment until the first documentation by the investigator of DP (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study \[this includes the baseline sum if that is the smallest on study\]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) per RECIST v1.1 or death from any cause, whichever occurred first. The median was estimated by using the Kaplan-Meier method and corresponding 2-sided 90% CI using Brookmeyer and Crowley methodology.
Time frame: Up to approximately 30 months
Population: Efficacy Population: All participants who received any portion of at least one dose of FPT155.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1 | 1.31 months |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1 | 1.38 months |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1 | 4.01 months |
| Phase 1a Monotherapy: FPT155 Dose D | Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1 | 1.41 months |
Secondary
Phase 1b Monotherapy: t1/2 of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: t1/2 of FPT155 | 5.7318 day | — |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: t1/2 of FPT155 | 6.9369 day | Standard Deviation 1.38733 |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: t1/2 of FPT155 | 5.7844 day | Standard Deviation 0.33807 |
Secondary
Phase 1b Monotherapy: Vss of FPT155
Time frame: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a Monotherapy: FPT155 Dose A | Phase 1b Monotherapy: Vss of FPT155 | 3492.6594 mL | — |
| Phase 1a Monotherapy: FPT155 Dose B | Phase 1b Monotherapy: Vss of FPT155 | 5006.6203 mL | Standard Deviation 1687.10134 |
| Phase 1a Monotherapy: FPT155 Dose C | Phase 1b Monotherapy: Vss of FPT155 | 4934.4888 mL | Standard Deviation 1711.72574 |