Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309
ConditionAdvanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharmAbcine
About this trial
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.
Eligibility criteria
Qualifiers
The participant voluntarily signs an informed consent form (ICF) indicating they understand the purpose and procedures required for the study and are willing to participate in the study.
Are at least 18 years of age.
Are diagnosed with advanced or metastatic solid tumors (non-lymphoma) by histology or pathology that is metastatic or unresectable and considered relapsed and/or refractory to prior therapy.
Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
Disqualifiers
Has received treatment with a VISTA targeting agent.
Has a history of positive testing for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-hepatitis C virus) or other clinically active liver disease, or positive testing at Screening for HBsAg or anti- hepatitis C virus.
HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
Has a medical condition which, in the opinion of the PI (or designee), places the participant at an unacceptably high risk for toxicity.
Trial design
Treatments tested in this trial
- PMC-309 monotherapy
- PMC-309 Dose Escalation in Combination with Pembrolizumab(KEYTRUDA®)
- PMC-309 Dose Expansion
Treatment groups
67 Participants
are divided into 3 treatment groupsSponsors and collaborators
PharmAbcine
Lead sponsor
Novotech (Australia) Pty Limited
Collaborator
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov