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
Axcynsis Therapeutics Pte Ltd
Summary
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
Description
This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AT03-65 in adults with advanced solid tumors. AT03-65 is administered via intravenous infusion using an accelerated escalation method for the lower 3 dose level groups and the 3 + 3 escalation method is used in the subsequent dose level groups. The study design is to identify the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) during 21-day cycle. One or more doses or regimens lower than or at the MTD m…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. At least 18 years old at the time of signing written informed consent form (ICF). 2. Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1 at screening and on C1D1. 3. Pathologically documented, definitively diagnosed, advanced/metastatic solid tumor that is resistant or refractory to standard treatment, for which no further standard treatment is available, or the subject refuses or cannot tolerate standard therapy. Subjects must have measurable lesion according to response evaluation criteria in solid tumors (RECIST) v1.1. 3a) Monotherapy dose e…
Interventions
- DrugAT03-65
Treatment will continue until disease progression, unacceptable toxicity, subject withdrawal of consent or death.
Location
- Oregon Health & Science University (OHSU)Portland, Oregon