XTX202 in Patients With Advanced Solid Tumors

Open to people ages 18 years and up

1. 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. Patients must have been treated with available standard therapy. 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 approved anti-PD-1 and a TKI. 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 an approved anti-PD-1 and an anti-CTLA4 checkpoint inhibitor
2. ECOG performance status of 0 or 1
3. Adequate organ function
4. Part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment.

1. Received prior treatment with IL-2 therapy
2. History of clinically significant pulmonary disease
3. History of clinically significant cardiovascular disease
4. Has a diagnosis of immunodeficiency
5. 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
6. Has an active infection requiring systemic therapy within 4 weeks prior to study treatment