Actively Recruiting
FIH Study to Evaluate Safety, Tolerability, PK, PD & Preliminary Efficacy of AT03-65 With Advanced Solid Tumors
Led by Axcynsis Therapeutics Pte Ltd · Updated on 2026-01-30
83
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase I, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AT03-65 in Adults with Advanced Solid Tumors
CONDITIONS
Official Title
FIH Study to Evaluate Safety, Tolerability, PK, PD & Preliminary Efficacy of AT03-65 With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at the time of signing informed consent.
- ECOG Performance Status score of 0 or 1 at screening and on Cycle 1 Day 1.
- Pathologically confirmed advanced or metastatic solid tumor resistant or refractory to standard treatment, with measurable lesions per RECIST v1.1.
- For Phase 1a monotherapy dose escalation: documented CLDN6 expression after lower three dose levels; includes ovarian, peritoneal, fallopian tube, endometrial, NSCLC, breast, esophageal, gastric/GEJ cancers.
- For Phase 1b monotherapy expansion: confirmed CLDN6 expression by immunohistochemistry.
- Cohort 1: advanced/metastatic CLDN6-expressing ovarian cancer, platinum resistant/refractory/non-tolerant, with at least one prior platinum-based chemotherapy.
- Cohort 2: advanced/metastatic CLDN6-expressing NSCLC with prior checkpoint inhibitor combination or platinum doublet therapy; progression on standard care for driver mutations.
- Cohort 3: other advanced/metastatic CLDN6-expressing solid tumors with exhausted standard treatment options.
- Availability of fresh tumor sample or archival block for CLDN6 testing (except lower three dose levels of Phase 1a).
- Good organ function.
- Left ventricular ejection fraction of at least 50% by echocardiogram or MUGA within 28 days prior to treatment.
- Life expectancy of at least 3 months.
- Agreement to use effective contraception during the study and for at least 6 months after final dose; males agree not to freeze or donate sperm during this time; females agree not to donate or retrieve ova.
You will not qualify if you...
- Systemic anti-cancer therapy within 4 weeks or according to drug half-life prior to first dose.
- Not recovered to Grade 1 or baseline for prior treatment toxicities, except alopecia.
- Recovery time after surgery less than 28 days.
- Clinically significant congenital or acquired cardiovascular diseases.
- Other active invasive cancers within 5 years except treated basal cell carcinoma or in situ cervical carcinoma.
- Severe or uncontrolled systemic diseases including hypertension, diabetes, bleeding disorders, or active infections requiring IV antibiotics.
- History or suspicion of significant lung disease.
- Receipt of live vaccine within 4 weeks prior to first dose.
- Active or untreated central nervous system or meningeal metastases, or leptomeningeal disease.
- Prior treatment with any antibody-drug conjugate targeting CLDN6.
- Previous allogeneic or autologous bone marrow transplant.
- Pregnancy or planning pregnancy.
- Use of moderate or strong CYP2C8, CYP3A inhibitors or inducers, or P-glycoprotein inhibitors within 14 days prior or unable to discontinue during study.
- Investigator judgment of unsuitability due to mental disorder, poor compliance, or other reasons.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
H
Humphrey Gardner
CONTACT
M
Maria DeAssis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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