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

NCT06809114 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2026-01-30

No results posted yet for this study

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

Conditions

Interventions

DRUG

AT03-65

Treatment will continue until disease progression, unacceptable toxicity, subject withdrawal of consent or death.

Sponsors & Collaborators

  • Axcynsis Therapeutics Pte Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-14
Primary Completion
2027-12-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06809114 on ClinicalTrials.gov