Actively Recruiting
Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309
Led by PharmAbcine · Updated on 2025-12-30
67
Participants Needed
4
Research Sites
329 weeks
Total Duration
On this page
Sponsors
P
PharmAbcine
Lead Sponsor
N
Novotech (Australia) Pty Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant voluntarily signs informed consent and agrees to study procedures
- At least 18 years of age
- Diagnosed with advanced or metastatic solid tumors (non-lymphoma) that are relapsed or refractory to prior therapy
- Progressed after treatment with anti-PD-1/L1 monoclonal antibody, confirmed by RECIST v1.1 and iRECIST v1.1 criteria
- Have measurable disease per RECIST v1.1 confirmed by CT or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Meet hematologic criteria: ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, hemoglobin ≥ 9.0 g/dL without recent transfusions
- Meet blood coagulation criteria: prothrombin time ≤ 1.5 × upper limit of normal (ULN), activated partial thromboplastin time ≤ 1.5 × ULN
- Meet hepatic function criteria: total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN; AST or ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastasis)
- Meet renal function criteria: creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL/min if above this threshold
- Willing and able to adhere to study prohibitions and restrictions
- Agree to use reliable contraception from screening until 120 days after last dose
- Women of childbearing potential must have negative pregnancy test at screening and agree to additional tests
- HIV-infected participants must be on stable antiretroviral therapy with well-controlled infection and CD4+ count ≥ 350 cells/mm³
You will not qualify if you...
- Prior treatment with a VISTA targeting agent
- History or current positive test for hepatitis B surface antigen or hepatitis C antibody, or active liver disease
- HIV-infected participants with history of Kaposi sarcoma or Multicentric Castleman Disease
- Medical conditions posing high risk for toxicity as judged by investigator
- Known additional progressing malignancy requiring treatment within past 3 years
- Participation in other investigational agent studies or anticancer immunotherapy within 4 weeks prior to first dose
- Active autoimmune disease requiring immunosuppressants within past 6 months or systemic treatment within past 2 years
- History of seizure disorder
- Oxygen-dependent chronic disease
- Serious grade 4 venous thromboembolic event, including pulmonary embolism
- Receiving therapeutic anticoagulants
- History of allogeneic tissue or solid organ transplant
- Major surgery within 4 weeks before first dose or planned during study participation
- Pregnant, breastfeeding, or planning pregnancy during study or within 120 days after last dose
- Men planning to father a child during study or within 3 months after last dose; must avoid sperm donation during treatment and specified period after
- Vaccinated with live vaccine within 30 days prior to first dose (except annual inactivated influenza vaccine)
- Received COVID-19 vaccine within 7 days before first dose
- Uncontrolled intercurrent illness including poorly controlled hypertension or diabetes, active infection, symptomatic heart failure, unstable angina, or active psychiatric disorder limiting compliance
- Diagnosis of immunodeficiency or receiving high-dose systemic corticosteroids or immunosuppressive therapy within 7 days prior to first dose
- Active central nervous system metastases or carcinomatous meningitis unless stable and steroid-free
- Prior allogeneic organ or bone marrow transplant
- Prior T-cell receptor-modified or CAR T-cell therapy
- Other anticancer therapy within 4 weeks prior to first dose
- Prior radiotherapy within 2 weeks before first dose except limited palliative radiation
- Unresolved toxicities from prior anti-tumor therapy greater than Grade 1 except alopecia, pigmentation, or hearing loss
- Discontinued prior anti-PD-1 or anti-PD-L1 therapy due to Grade 3 or higher immune-related adverse event
- Active autoimmune disease requiring systemic treatment
- History or current pneumonitis or interstitial lung disease requiring steroids
- Class III or IV heart failure by NYHA criteria
- History of abdominal fistula or gastrointestinal perforation within 6 months
- History of serious gastrointestinal hemorrhage within 6 months
- History of hypertensive crisis or encephalopathy
- History of posterior reversible encephalopathy syndrome
- Social situations limiting compliance with study requirements
- Receiving chronic systemic corticosteroids exceeding 10 mg prednisone equivalent daily or other immunosuppressive therapy within 7 days prior to first dose; inhaled or topical steroids allowed if no active autoimmune disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Australian Hospital Care (Pindara) PTY LTD. Trading as Pindara Private Hospital
Benowa, Queensland, Australia, 4217
Actively Recruiting
2
Ballarat Regional Integrated Cancer Centre (Grampians Health)
Ballarat, Victoria, Australia, 3350
Actively Recruiting
3
Cabrini Health Limited
Malvern, Victoria, Australia, 3144
Actively Recruiting
4
Alfred Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
H
Hyojin Koh, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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