Evaluation of XYA02 in Patients With Advanced Solid Tumors
- Sponsor
- XYone Therapeutics, Inc
- Study ID
- NCT07670312
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Colorectal Cancer
- GEJ Adenocarcinoma
- MUC1-expressing Advanced, Relapsed and/or Refractory Solid Tumors
- Non-Small Cell Lung Cancer
- Ovarian Cancer
- Pancreatic Adenocarcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- XYA02 — BIOLOGICALIV infusion
Study Details
This study will evaluate the safety, tolerability, and efficacy of XYA02 in participants with advanced solid tumors.
Key Dates
- First listed
- Jun 26, 2026
- Start date
- Jul 15, 2026
- Status verified
- Jul 2026
- Primary completion
- Jul 15, 2029
- Completion
- Jul 15, 2030
Study Design
- Enrollment
- 190 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose EscalationParticipants with locally advanced, relapsed, or refractory tumors who will receive an intravenous (IV) infusion of XYA02.
- Experimental: Dose ExpansionMultiple expansion cohorts targeting various advanced solid tumors who will receive an intravenous (IV) infusion of XYA02.
Primary Outcome Measure
Frequency of Treatment Emergent Adverse Events of XYA02 [ Time Frame: From enrollment for a minimum of 16 weeks ]
Central Contacts
- Tiffany Sepp617-710-0770
- Anshu Goyal917-445-1846
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