XTX202 in Patients With Advanced Solid Tumors

Completed · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors

Key facts

Study ID

NCT05052268

Run by

Xilio Development, Inc.

People needed

95

Starts

2022-01-18

Expected to finish

2025-03-25

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Disease Criteria
• Phase 1, Part 1a: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available
• Phase 1, Part 1b: Histologically or cytologically confirmed solid tumor malignancy with one of the following tumor histologies: RCC of clear cell histology only, melanoma, squamous cell skin carcinoma, ovarian cancer, non-small cell lung cancer. Those patients who previously received immunotherapy must have derived benefit from this treatment. Additionally, patients with any of the above histologies in an advanced setting who plan to undergo debulking surgery or oligometastasectomy may be eligible to receive 2 cycles of XTX202 treatment in a "window of opportunity" subcohort".
• Phase 2, Part 2a: Patients with metastatic RCC who have previously been treated with an anti-PD-1 and a TKI, per local and institutional SOC. Patients must have progressed on treatment with an anti-PD-1 mAb administered either as monotherapy or in combination with other therapies
• Phase 2, Part 2b: Patients with unresectable or metastatic melanoma who have previously been treated with at least 1 prior line of therapy in the recurrent or metastatic setting. Prior therapy must have included an anti-PD-1 alone or in combination per local and institutional standard of care, and patient must have progressed on checkpoint inhibitor therapy. Patients with BRAF V600-activating mutation must have previously received targeted therapy per local and institutional standard of care.
• ECOG performance status of 0 or 1
• Adequate organ function
• Part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment.

You may not qualify if…

• Received prior treatment with IL-2 therapy
• History of clinically significant pulmonary disease
• History of clinically significant cardiovascular disease
• Has a diagnosis of immunodeficiency
• Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs
• Has an active infection requiring systemic therapy within 4 weeks prior to study treatment

Where it is running

• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian- Newport Beach — Newport Beach, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• HealthPartners Cancer Center at Regions Hospital — Saint Paul, Minnesota, United States
• Atlantic Health System/Morristown Medical Center — Morristown, New Jersey, United States
• Rutgers Cancer Institute of NJ — New Brunswick, New Jersey, United States
• Carolina BioOncology Institute — Huntersville, North Carolina, United States
• The Ohio State University Wexner Medical Center James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States
• UPMC Hillman Cancer Center Pavilion — Pittsburgh, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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