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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Axcynsis Therapeutics Pte Ltd
Study ID
NCT06809114
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jan 14, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
83 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AT03-65 Dose Escalation and Dose Expansion
    Subjects will receive AT03-65 via intravenous (IV) infusion on Day 1 of a 21-Day treatment cycle.

Primary Outcome Measure

Maximum tolerated dose (MTD) of AT03-65 [ Time Frame: Up to 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science University (OHSU)PortlandOregon97239
Knight Cancer Institute Trial Center
[email protected]
503-494-1080

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By research site
Oregon Health & Science University (OHSU)· Portland, OR

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