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

NCT05957081 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-12-30

No results posted yet for this study

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.

Conditions

  • Advanced or Metastatic Solid Tumors

Interventions

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®)

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • PharmAbcine

    lead INDUSTRY

Principal Investigators

  • Andrea Tazbirkova, Dr · Pindara Private Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2029-10-30
Completion
2030-04-30

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05957081 on ClinicalTrials.gov