Advanced Solid Tumors, Gastric Cancer, Transitional Cell Carcinoma of the Bladder
Conditions
Keywords
FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer
Brief summary
This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.
Detailed description
Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients. Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.
Interventions
DRUGFPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Sponsors
Five Prime Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Life expectancy of at least 3 months * ECOG performance status of 0 to 1 • In sexually-active patients, willingness to use 2 effective methods of contraception * Adequate hematological and organ function, confirmed by lab values * Tumor tissue must be available for prospective determination of FGFR2b overexpression * Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment * Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract * Measurable disease as defined by RECIST version 1.1
Exclusion criteria
* Untreated or symptomatic central nervous system (CNS) metastases * Impaired cardiac function or clinically significant cardiac disease \- Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs \</=14 days (\</=28 days for patients in Korea) prior to first dose of FPA144 * Ongoing acute adverse effects from prior anticancer or investigational therapy \> NCI CTCAE Grade 1 * Retinal disease or a history of retinal disease or detachment * Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea * Major surgical procedures are not allowed ≤28 days prior to FPA144 administration * Females who are pregnant or breastfeeding; women of childbearing potential must not be considering getting pregnant during the study \- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study * Known allergy or hypersensitivity to components of the FPA144 formulation including polysorbate * History of prior malignancy except: * a) Curatively treated non-melanoma skin cancer or * b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or * c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect * Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). | 4 weeks on average | Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs) |
| Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only) | 16 weeks on average | Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration | 16 weeks on average | Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2. • Summary of area under serum concentration-time curve, maximum serum concentration, |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 16 weeks on average | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Duration of Response Per RECIST 1.1 (Part 2 Only) | 16 weeks on average | Duration of complete or partial response with 95% confidence intervals in gastric cancer population. |
| Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve | 16 weeks on average | Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2. • Summary of area under serum concentration-time curve, maximum serum concentration, |
Countries
South Korea, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 4 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.. | 3 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles. | 1 |
| Part 1B: FPA144 Dose Escalation Gastric 6 mg/kg 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles. | 1 |
| Part 1B: FPA144 Dose Escalation Gastric 10 mg/kg 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 15 mg/kg IV every 2 weeks in 28 day cycles. | 6 |
| Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B. | 52 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Other | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Progressive Disease | 2 | 3 | 2 | 3 | 3 | 3 | 1 | 1 | 5 | 39 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 |
Baseline characteristics
| Characteristic | Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg | Part 1B: FPA144 Dose Escalation Gastric 6 mg/kg | Part 1B: FPA144 Dose Escalation Gastric 10 mg/kg | Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 74 years | 64.5 years | 63 years | 62 years | 64 years | 59 years | 54 years | 39 years | 52 years | 57 years | 59 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants | 39 Participants | 46 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 11 Participants | 31 Participants |
| Region of Enrollment South Korea | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants | 5 participants | 33 participants | 40 participants |
| Region of Enrollment Taiwan | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 5 participants | 5 participants |
| Region of Enrollment United States | 3 participants | 4 participants | 3 participants | 3 participants | 3 participants | 3 participants | 0 participants | 0 participants | 1 participants | 14 participants | 34 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants | 21 Participants | 33 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 31 Participants | 46 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 1 | 0 / 1 | 0 / 6 | 5 / 52 |
| other Total, other adverse events | 3 / 3 | 4 / 4 | 3 / 3 | 3 / 3 | 2 / 3 | 3 / 3 | 1 / 1 | 1 / 1 | 6 / 6 | 48 / 52 |
| serious Total, serious adverse events | 1 / 3 | 0 / 4 | 2 / 3 | 0 / 3 | 0 / 3 | 1 / 3 | 0 / 1 | 0 / 1 | 2 / 6 | 17 / 52 |
Outcome results
Primary
Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)
Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)
Time frame: 16 weeks on average
Population: All patients who received FPA144
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only) | 1 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg | Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only) | 1 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg | Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only) | 6 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg | Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only) | 48 Participants |
Primary
Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).
Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)
Time frame: 4 weeks on average
Population: All patients who received FPA144
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). | 0 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg | Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). | 0 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg | Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). | 0 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg | Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). | 0 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). | 0 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). | 0 Participants |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg | Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). | 0 Participants |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg | Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). | 0 Participants |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg | Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). | 0 Participants |
Secondary
Duration of Response Per RECIST 1.1 (Part 2 Only)
Duration of complete or partial response with 95% confidence intervals in gastric cancer population.
Time frame: 16 weeks on average
Population: Gastric cancer patients with various levels of FGFR2b overexpression treated with FPA144 who had an objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Duration of Response Per RECIST 1.1 (Part 2 Only) | 14.1 Weeks |
Secondary
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 16 weeks on average
Population: Patients with various levels of FGFR2b overexpression in tumor samples treated with bemarituzumab who had baseline and post baseline scans performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 1 Participants |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 1 Participants |
| Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 4 Participants |
Secondary
Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve
Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2. • Summary of area under serum concentration-time curve, maximum serum concentration,
Time frame: 16 weeks on average
Population: All patients in the PK Full Analysis Population who have sufficient PK samples for the calculation of at least one PK parameter on at least one Study Day. Dose normalized PK parameters were reported so that patients at 0.3 mg/kg were excluded from mean value for part 1a because it is in the non-linear dose range.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve | 1.288 ug*day/ml | Standard Deviation 0.5159 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve | 1.547 ug*day/ml | Standard Deviation 0.2902 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve | 1.427 ug*day/ml | Standard Deviation 0.2367 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve | 1.863 ug*day/ml | Standard Deviation 0.4119 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve | 1.697 ug*day/ml | Standard Deviation 0.1464 |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg | Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve | 2.69 ug*day/ml | Standard Deviation 0 |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve | 1.59 ug*day/ml | Standard Deviation 0 |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve | 1.648 ug*day/ml | Standard Deviation 0.4055 |
| Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors | Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve | 1.867 ug*day/ml | Standard Deviation 0.4495 |
Secondary
Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration
Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2. • Summary of area under serum concentration-time curve, maximum serum concentration,
Time frame: 16 weeks on average
Population: All patients in the PK Full Analysis Population who have sufficient PK samples for the calculation of at least one PK parameter on at least one Study Day. Dose normalized PK parameters were reported so that patients at 0.3 mg/kg were excluded from mean value for part 1a because it is in the non-linear dose range.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration | 0.2483 ug/ml | Standard Deviation 0.08763 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration | 0.3117 ug/ml | Standard Deviation 0.06536 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration | 0.2873 ug/ml | Standard Deviation 0.02793 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration | 0.4097 ug/ml | Standard Deviation 0.03208 |
| Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration | 0.3847 ug/ml | Standard Deviation 0.14931 |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg | Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration | 0.4900 ug/ml | Standard Deviation 0 |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration | 0.232 ug/ml | Standard Deviation 0 |
| Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg | Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration | 0.2990 ug/ml | Standard Deviation 0.0669 |
| Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors | Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration | 0.3145 ug/ml | Standard Deviation 0.06981 |