NCT05957081

Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309

A Phase 1a/1b, First-in-Human, Open Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of PMC-309 (Anti-VISTA), as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: PharmAbcine · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1a/1b, first-in-human (FIH), open label study to evaluate the safety, tolerability, and pharmacokinetics (PK) of PMC-309, a mAb against the human VISTA ligand, in participants with advanced or metastatic solid tumors administered as a monotherapy and in combination with pembrolizumab.

Detailed description

Phase 1a is a 2-part dose escalation; both part will adopt the modified toxicity probability interval (mTPI) design with a dose limiting toxicity (DLT) rate of 30% for dose finding. * Part A is planned as a PMC-309 dose escalation. * Part B: is planned as a PMC-309 dose escalation in combination with pembrolizumab. Phase 1b is planned as a cohort expansion with PMC-309 administered as a monotherapy (Cohort A) at the preliminary recommended Phase 2 dose (RP2D) found at Phase 1a (Part A) and in combination with pembrolizumab (Cohort B) with PMC-309 at the maximum tolerated dose (MTD)/preliminary recommended Phase 2 dose (RP2D) found at Phase 1a (Part B). A minimum of 67 participants are to be enrolled to the study. Treatment Groups: Phase 1a Part A: PMC-309 Phase 1a Part B: PMC-309 + Pembrolizumab Phase 1b Cohort A: PMC-309 Phase 1b Cohort B: PMC-309 + Pembrolizumab Estimated overall study duration: approximately 2 to 6 years Dosing Cycle: the duration of a treatment cycle is 3 weeks/21 days.

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	PMC-309 monotherapy	PMC-309 will be administered intravenously.
DRUG	PMC-309 Dose Escalation in Combination with Pembrolizumab(KEYTRUDA®)	Both PMC-309 and pembrolizumab will be administered intravenously. At the time of the combination therapy (Week 1/Day 1 of each cycle), participants will be dosed with pembrolizumab(KEYTRUDA®) first, administered over 0.5 hours (± 10 minutes). Following an interval of 1 hour (± 15 minutes), participants will be dosed with PMC-309 administered over 1 hour (± 0.5 hours), after which participants will be observed for a period of 1.5 hours post administration.
DRUG	PMC-309 Dose Expansion	Phase 1b will enroll participants with advanced or metastatic tumor types into 1 of 2 cohorts: * Cohort A: PMC-309 monotherapy therapy \- PMC-309 dosing will be at the preliminary RP2D, as identified in Phase 1a: Part A * Cohort B: PMC-309 plus pembrolizumab(KEYTRUDA®) combination therapy - PMC-309 dosing will be as identified in Phase 1a: Part B in combination with 200 mg pembrolizumab(KEYTRUDA®)

Timeline

• Start date: 2024-01-03
• Primary completion: 2029-10-30
• Completion: 2030-04-30
• First posted: 2023-07-24
• Last updated: 2025-12-30

Locations

4 sites across 1 country: Australia