Actively Recruiting
A Phase 1/2 Open-label Study of Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, Including Selected Malignancies
Led by AP Biosciences Inc. · Updated on 2025-03-26
168
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AP203, a drug being studied in adults with locally advanced or metastatic solid tumors, including specific cancers like non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and esophageal squamous cell carcinoma (ESCC). This open-label study involves two phases: dose escalation to find safe dose levels, and dose expansion to further assess the drug in selected tumor types. The goal is to understand the safety, how the drug moves through and affects the body, immune responses, and anti-tumor effects. Participants receive AP203 through intravenous infusion. In the dose escalation phase, eight dose levels from 0.00064 to 20 mg/kg are tested weekly for the first 3 weeks, then every 2 weeks afterward to find the maximum tolerated or recommended phase 2 dose. The dose expansion phase follows, giving participants the recommended dose on the same schedule to study its effect in specific cancers. The study is non-randomized and open-label, meaning both patients and researchers know the treatment given. During the study, participants are closely monitored for side effects and toxicities, with assessments for adverse events up to 90 days after the last dose. Tumor response is measured using imaging criteria (RECIST v1.1), and participants undergo regular blood tests to check organ function and immune responses. The study includes safety evaluations during the first 28 days and after repeated doses. Participants remain in the study until disease progression or unacceptable side effects, with overall safety and clinical activity tracked throughout the trial period, which is expected to continue until December 2027.
CONDITIONS
Brief Title
A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before screening.
- Adults with ECOG performance status of 0 to 1 and life expectancy of at least 3 months.
- Have at least one measurable tumor lesion per RECIST version 1.1.
- Adequate organ function by specified blood counts and liver/kidney function tests.
- Use highly effective contraception if risk of conception exists.
- Dose escalation phase: Histologically or cytologically confirmed locally unresectable advanced or metastatic solid tumors refractory or intolerant to standard therapy or with no standard therapy.
- Dose expansion phase: Confirmed relapsed or refractory, locally unresectable advanced or metastatic NSCLC, HNSCC, or ESCC with prior systemic treatment including anti-PD-1 or anti-PD-L1 therapy.
- NSCLC cohort: Tumors expressing PD L1 (TPS ≥ 1%), no sensitive EGFR mutation or ALK rearrangement, and no actionable genomic alterations.
- HNSCC cohort: Squamous cell carcinoma (excluding nasopharynx) refractory or intolerant to platinum-based chemotherapy, with PD L1 CPS ≥ 1.
- ESCC cohort: Squamous carcinoma with PD L1 CPS ≥ 1.
You will not qualify if you...
- Received concurrent antitumor treatment or investigational products within 28 days before study intervention.
- Major surgery within 28 days before study intervention (excluding biopsy).
- Unresolved toxicities from prior treatments above specified grades.
- History of immune-mediated adverse events leading to immunotherapy discontinuation.
- Previous malignant disease within 2 years except certain skin, bladder, or cervical cancers.
- Active leptomeningeal disease or uncontrolled brain metastasis.
- Received organ transplantation including stem cell transplantation.
- Significant infections including HIV, untreated or unstable hepatitis B or active hepatitis C.
- Active or history of autoimmune disease that may relapse, except specified conditions.
- Known severe hypersensitivity to monoclonal antibodies.
- Pregnancy or lactation.
- Known alcohol or drug abuse.
- Significant active cardiovascular disease.
- Psychiatric condition preventing informed consent.
- Live vaccination within 28 days before first dose and during study.
- Any other significant disease impairing tolerance to study intervention.
- Dose expansion phase specific: Prior therapy with any PD-L1 x CD137 bispecific antibody.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive AP203 by intravenous infusion. For the first 3 weeks, infusions are given weekly (every 1 week ± 1 day) for the first 4 doses, then every 2 weeks (± 3 days) for subsequent doses. Dose levels vary based on escalation or expansion cohort.
Weekly infusions for the first 3 weeks, then biweekly infusions thereafter
Duration - Up to 90 days after last dose
Participants are monitored for adverse events and overall response after the last dose of AP203.
Visits as needed for safety monitoring up to 90 days post-treatment
Trial Site Locations
Total: 1 location
1
AP Biosciences Inc.
Taipei, Taiwan, 115011
Actively Recruiting
Research Team
Y
Ya Shen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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