Clinical trial NCT06779851: A Study to Evaluate Safety and Tolerability of BPT567 in Patients With Advanced Solid Tumors
Official title: A Phase 1 Investigation of the Safety, Tolerability and Preliminary Antitumor Activity of BPT567, a Multifunctional PD1-IL18 Immunocytokine in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Solid Tumors
Lead sponsor: Bright Peak Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Ph1a Dose Escalation followed by and Ph 1b Dose Expansion study including multiple expansion cohorts
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of dose limiting toxicity (DLT), Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
timeFrame: Duration of first cycle (28 Days) for each cohort evaluated
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: Through end of study (up to 2 years)
Secondary outcomes:
measure: Pharmacokinetic parameter - Maximum Concentration (Cmax)
timeFrame: 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)
measure: Pharmacokinetic parameter - Time to Maximumn Concentration (Tmax)
timeFrame: 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)
measure: Pharmacokinetic parameter - Terminal Elimination Half-life (T1/2)
timeFrame: 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)
measure: Pharmacokinetic parameter - Area under the plasma concentration curve up to the last quantifiable time-point ((AUC)0-last))
timeFrame: 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)
measure: Pharmacokinetic parameter - Area area under the curve from 0 to infinite time (AUC0-inf)
timeFrame: 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)
measure: Anti-drug Antibody (ADA) Response to BPT567
timeFrame: Predose and postdose at multiple timepoints up to end of treatment (up to 2 years)
measure: Objective response rate (ORR)
timeFrame: Through study completion up to 2 years
measure: Duration of response (DoR)
timeFrame: Through study completion up to 2 years
measure: Disease Control Rate (DCR)
timeFrame: Through study completion up to 2 years
measure: Progression Free Survival (PFS)
timeFrame: Through study completion up to 2 years
Other outcomes:
measure: Evaluate changes in immune cell composition and tumor genome.
timeFrame: Through study completion up to 2 years
Locations:
city: Scottsdale
country: United States
facility: Honor Health Research Institute
state: Arizona
city: Grand Rapids
country: United States
facility: Start Midwest
state: Michigan
city: Huntersville
country: United States
facility: Carolina BioOncology Institute
state: North Carolina
Study officials:
References: