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Study of AT03-65 for Advanced Solid Tumors

This study is testing a new drug called AT03-65 in adults with advanced solid tumors that have not responded to standard treatments. The main goals are to find the safest dose of AT03-65 and understand its side effects. Researchers will also look at how the drug moves through the body (pharmacokinetics) and its early effects on the tumor (preliminary efficacy). You may be able to join if you are at least 18 years old, have a solid tumor that has progressed, and are generally well enough to participate. This is a first-in-human study, meaning it's one of the first times this drug is being tested in people.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know you are receiving AT03-65. It plans to enroll 83 participants.
What's involved
Treatment with AT03-65 will continue until your disease gets worse, you experience unacceptable side effects, you decide to stop, or you pass away. The study will monitor for side effects and the maximum tolerated dose for up to 21 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for safety are measured up to 21 days.

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NCT06809114

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Axcynsis Therapeutics Pte Ltd
~83 participants
Updated 2026-01-30 on ClinicalTrials.gov
What's tested:AT03-65

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD) of AT03-65
Measured over Up to 21 days
+1 more outcome measured

Conditions

Solid Tumor

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Lung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmSolid Neoplasm

Where it's being run

1 sites across 1 states
Oregon1

Who to contact

Humphrey Gardner
[email protected]
7813756856
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subjects (with documented CLDN6 expression after the lower three dose levels) will be enrolled, including but not limited to the following histological subtypes: serous or endometrioid ovarian cancer, primary peritoneal cancer or fallopian tube cancer, endometrial cancer, NSCLC, breast cancer, esophageal cancer, and gastric/GEJ cancer. There is no upper limit on the number of prior treatment regimens the subject may have received.
Subjects must meet the minimum requirement of CLDN6-expressing by IHC (cutoff value to be determined based on Phase Ia data and/or clinical studies of other CLDN6-targeting drugs), to be confirmed prior to enrollment.

What this trial measures

  • Maximum tolerated dose (MTD) of AT03-65Up to 21 days

    The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.

  • Dose-limiting toxicity (DLT)Up to 21 days

    DLT refers to AEs that occurred during DLT observation period in dose escalation study, excluding toxicities clearly due to the underlying disease or extraneous causes.