Actively Recruiting
A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors
Led by AP Biosciences Inc. · Updated on 2025-04-25
85
Participants Needed
3
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2, multi-regional, multi-center, open-label, first-in-human (FIH), dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of AP402 in HER2-positive patients with locally or advanced solid tumors.
CONDITIONS
Official Title
A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed locally unresectable advanced or metastatic HER2-positive solid tumors with no suitable standard therapy
- Adults aged 18 years or older at the time of consent
- Provided written informed consent before screening
- ECOG performance status of 0 to 1 and life expectancy of at least 3 months
- At least one measurable tumor lesion (1 cm or larger) by RECIST 1.1
- Adequate organ function including neutrophil count, platelet count, hemoglobin, liver enzymes, bilirubin, alkaline phosphatase, coagulation tests, creatinine clearance, and albumin
- Female patients must not be pregnant or breastfeeding and must use effective contraception during the study and follow-up
- Male patients must be surgically sterile or use effective contraception if sexually active with women of childbearing potential
You will not qualify if you...
- Received other antitumor treatments or investigational products within 28 days or 5 half-lives prior to study drug
- Received CD137-targeted therapies within 28 days or 5 half-lives prior to study drug
- Major surgery within 28 days prior to study drug (except diagnostic biopsy)
- Ongoing toxicities from prior cancer treatments greater than Grade 1 (except alopecia and mild neuropathy)
- History of immune-related adverse events causing immunotherapy discontinuation
- Other cancers within the last 2 years except certain skin or bladder cancers and carcinoma in situ
- Active leptomeningeal disease or untreated brain metastases
- Received organ transplantation including stem cell transplantation
- Active infections including recent systemic antibiotic, antifungal, antiviral use, HIV positive, untreated active hepatitis B or C
- Active or history of autoimmune disease requiring immunosuppression
- Known severe allergic reactions to monoclonal antibodies
- Pregnant or breastfeeding women
- Known drug or alcohol abuse
- Significant cardiovascular diseases or reduced heart function
- Psychiatric conditions preventing informed consent
- Live vaccinations within 28 days before study drug
- Any other significant disease that may impair treatment tolerance according to investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Macquarie University Clinical Trials Unit
Macquarie, New South Wales, Australia, 2109
Not Yet Recruiting
2
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5043
Not Yet Recruiting
3
Linear Clinical Research
Perth, Western Australia, Australia, 6009
Actively Recruiting
Research Team
L
Linnea Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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