NCT06809114

FIH Study to Evaluate Safety, Tolerability, PK, PD & Preliminary Efficacy of AT03-65 With Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: Axcynsis Therapeutics Pte Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 may be selected for further evaluations under Dose Expansion to further evaluate the IMP and identify the RP2D.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	AT03-65	Treatment will continue until disease progression, unacceptable toxicity, subject withdrawal of consent or death.

Timeline

• Start date: 2026-01-14
• Primary completion: 2027-12-01
• Completion: 2028-08-01
• First posted: 2025-02-05
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study