Advanced Solid Tumors
Conditions
Keywords
Solid Tumors
Brief summary
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and maximum tolerated dose (MTD) or maximum adminstered dose (MAD) of BPT567 in patients with advanced solid tumors, and establish the recommended dose for expansion cohorts.
Interventions
DRUGBPT567
Immunocytokine infusion
Sponsors
Bright Peak Therapeutics Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Ph1a Dose Escalation followed by and Ph 1b Dose Expansion study including multiple expansion cohorts
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged ≥18 years at the time of signing informed consent form * Measurable disease per RECIST 1.1 * Histologically- or cytologically-diagnosed, locally advanced unresectable or metastatic solid tumor. Progressed or recurred after previously having received approved standard of care agents that are approved and available in their local geography. * ECOG Performance status of 0 or 1 * Life expectancy of at least 3 months * Adequate organ and marrow function * Contraception during study participation, as applicable
Exclusion criteria
* Has received systemic small molecule therapy or radiation therapy within 28 days prior to the first dose. * Treatment with biologic agents including anti-PD-1 or PD-L1 antibodies for less than 6 weeks or 5 half-lives, whichever is shorter, prior to first dose. * Received any investigational agent less than 28 days or 5 half-lives, whichever is shorter, prior to the first dose. * Treatment with another IL-18 therapy. * Received systemic immunosuppressive agents greater than the equivalent of prednisone 10mg daily within 14 days of the study, though inhaled, intranasal, topical or intra-articular corticosteroids are allowed. * Certain clinically significant intercurrent disease. * Primary immune deficiency. * Active untreated brain or spine metastasis or leptomeningeal metastases. * Known HIV seroposivitiy, although patients treated for HIV with no detectable viral load for at least 1 month while on a stable regimen of agents are permitted. * Active hepatitis A or acute or chroming hepatitis B or C infection. * Received a live virus vaccine within 30 days of enrollment or a COVD vaccine within 14 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose limiting toxicity (DLT), Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) | Duration of first cycle (28 Days) for each cohort evaluated | The MTD will be the highest tested dose of BPT567 at which protocol specified number of patients experience DLT or the MAD, highest administered dose in the absence of DLTs |
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through end of study (up to 2 years) | Rate of subjects reporting adverse events or serious adverse events including abnormalities in safety laboratory results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameter - Maximum Concentration (Cmax) | Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years) | Maximum concentration of BPT567 |
| Pharmacokinetic parameter - Time to Maximumn Concentration (Tmax) | Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years) | Time to maximum concentration of BPT567 |
| Pharmacokinetic parameter - Terminal Elimination Half-life (T1/2) | Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years) | Terminal elimination half-life of BPT567 |
| Pharmacokinetic parameter - Area under the plasma concentration curve up to the last quantifiable time-point ((AUC)0-last)) | Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years) | (AUC)0-last of BPT567 |
| Pharmacokinetic parameter - Area area under the curve from 0 to infinite time (AUC0-inf) | Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years) | AUC0-inf of BPT567 |
| Anti-drug Antibody (ADA) Response to BPT567 | Predose and postdose at multiple timepoints up to end of treatment (up to 2 years) | Number of Participants With Anti-drug Antibody (ADA) Response to BPT567 |
| Objective response rate (ORR) | Through study completion up to 2 years | Per RECIST V1.1 |
| Duration of response (DoR) | Through study completion up to 2 years | Per RECIST V1.1 |
| Disease Control Rate (DCR) | Through study completion up to 2 years | Per RECIST V1.1 |
| Progression Free Survival (PFS) | Through study completion up to 2 years | Per RECIST V1.1 |
Countries
United States
Outcome results
None listed