67
Participants
Start Date
November 28, 2023
Primary Completion Date
September 10, 2025
Study Completion Date
October 4, 2028
PMC-309 monotherapy
PMC-309 will be administered intravenously.
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.
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"
Alfred Health, Melbourne
Cabrini Health Limited, Malvern
Ballarat Regional Integrated Cancer Centre (Grampians Health), Ballarat
Australian Hospital Care (Pindara) PTY LTD. Trading as Pindara Private Hospital, Benowa
Lead Sponsor
Novotech (Australia) Pty Limited
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
PharmAbcine
INDUSTRY