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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

November 28, 2023

Primary Completion Date

September 10, 2025

Study Completion Date

October 4, 2028

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

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 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 combination therapy - PMC-309 dosing will be as identified in Phase 1a: Part B in combination with 200 mg pembrolizumab"

Trial Locations (4)

3004

Alfred Health, Melbourne

3144

Cabrini Health Limited, Malvern

3350

Ballarat Regional Integrated Cancer Centre (Grampians Health), Ballarat

4217

Australian Hospital Care (Pindara) PTY LTD. Trading as Pindara Private Hospital, Benowa

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Novotech (Australia) Pty Limited

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

PharmAbcine

INDUSTRY

NCT05957081 - Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309 | Biotech Hunter | Biotech Hunter