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XYA02 in Advanced Solid Tumors

NCT07670312Phase 2

Key facts

Status: Recruiting
Start: Sep 2026
Primary completion: Sep 2029
Countries: 1
Sponsor: XYone Therapeutics

Drugs: XYA02
Conditions: solid tumornon-small cell lung cancer (NSCLC)ovarian cancergastroesophageal junction adenocarcinomacolorectal cancer (CRC)

Overview

Phase 2, open-label trial of XYA02 in solid tumor, non-small cell lung cancer (NSCLC), ovarian cancer and 4 more (2 arms), sponsored by XYone Therapeutics. Primary endpoints: Treatment Emergent Adverse Events at 16 weeks and Maximum Tolerated Dose at 16 weeks. Started Sep 2026; status: recruiting.

Design

2 arms

Study design: Non-randomizedOpen-label

Dose Escalation
Participants receive escalating doses of XYA02 IV infusion.
Dose Expansion
Participants in specific tumor cohorts receive XYA02 IV infusion at the determined dose.

Who it enrols

Adults with advanced, relapsed/refractory solid tumors (NSCLC, ovarian, gastric/GEJ, CRC, pancreatic) who have progressed on at least 1 prior systemic therapy. Must have adequate organ function and ECOG 0-1. Excludes patients refractory to TOP1 inhibitor ADCs, with active brain metastases, or significant cardiac history.

Endpoints

Primary

Treatment Emergent Adverse Events16 weeks
Maximum Tolerated Dose16 weeks

Secondary

Anti-tumor activity2 years
Pharmacokinetics16 weeks
Anti-Drug Antibodies16 weeks
Biomarkers of response16 weeks

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