NCT05957081 (MarkV-01) is a Phase 1 clinical trial of PMC-309 monotherapy in Advanced or Metastatic Solid Tumors, sponsored by PharmAbcine.

Who is sponsoring NCT05957081?

NCT05957081 is sponsored by PharmAbcine.

What drugs are being tested in NCT05957081?

Interventions in NCT05957081: PMC-309 monotherapy, PMC-309 Dose Escalation in Combination with Pembrolizumab(KEYTRUDA®), PMC-309 Dose Expansion.

What condition does NCT05957081 study?

NCT05957081 studies Advanced or Metastatic Solid Tumors.

Is NCT05957081 still recruiting?

NCT05957081 is currently recruiting now. Last updated 30 December 2025.

Last reviewed 2025-12-30 · How we verify

NCT05957081: MarkV-01

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 1 Last updated 30 December 2025

What this trial tests

Phase 1 trial testing PMC-309 monotherapy in Advanced or Metastatic Solid Tumors in 67 participants. Currently enrolling.

Timeline

3 January 2024

Primary endpoint
30 October 2029

30 April 2030

Quick facts

Lead sponsor	PharmAbcine
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	3 January 2024
Primary completion	30 October 2029
Estimated completion	30 April 2030
Sites	4 locations across Australia

Drugs / interventions tested

PMC-309 monotherapy — full drug profile →
PMC-309 Dose Escalation in Combination with Pembrolizumab(KEYTRUDA®) — full drug profile →
PMC-309 Dose Expansion — full drug profile →

Conditions studied

Advanced or Metastatic Solid Tumors — all drugs for Advanced or Metastatic Solid Tumors →

Sponsor

PharmAbcine — full company profile →

Who can join

18 and older, any sex, with Advanced or Metastatic Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Emerging Immunotherapy Targets in Early Drug Development.
Morchón-Araujo D, Catani G, Mirallas O, Pretelli G, et al · · 2025 · cited 6× · PMID 40508202 · DOI 10.3390/ijms26115394

Verify or expand the search:

Other recruiting trials for Advanced or Metastatic Solid Tumors

Currently open trials in the same condition.

NCT07510828 — PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07205718 — A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07260305 — A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolima · Phase 1 · recruiting
NCT06548217 — A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting
NCT06074497 — This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Mo · Phase 1 · active not recruiting

Other PharmAbcine trials

Trials by the same sponsor.

NCT05953012 — Study to Assess Safety and Tolerability of PMC-403 in Subjects With Neovascular Age-related Macular Degeneration · Phase 1 · completed
NCT04986852 — Olinvacimab With Pembrolizumab in Patients With mTNBC · Phase 2 · terminated
NCT03856099 — TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab · Phase 2 · terminated
NCT03722342 — TTAC-0001 and Pembrolizumab Combination phase1b Trial in Recurrent Glioblastoma · Phase 1 · unknown
NCT03720431 — TTAC-0001 and Pembrolizumab Phase Ib Combination Trial in Metastatic Triple-negative Breast Cancer · Phase 1 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05957081 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PharmAbcine
Last refreshed: 30 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05957081.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing