XTX202

P1/2, N=189, Active, not recruiting, Xilio Development, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Apr 2024 --> Feb 2026 | Trial primary completion date: Apr 2024 --> Feb 2026

Background High-dose recombinant human interleukin-2 (IL-2, aldesleukin) is approved for the treatment of renal cell carcinoma (RCC) and melanoma based on durable responses. Clinical testing of XTX202 is ongoing ( NCT05052268 ). Ethics Approval All animal procedures were either approved by an Institutional Animal Care and Use Committee and conducted in accordance with the National Institutes of Health Guide for the Care and Use of Laboratory Animals.

Part 2b will enroll patients with unresectable or metastatic melanoma who have received immune-checkpoint therapy with an anti-PD-1 therapy and an anti-CTLA-4 therapy to determine the efficacy of XTX202 monotherapy in this population. Enrollment to the study began in January 2022.

Funding: Xilio Therapeutics Background: High-dose recombinant human interleukin-2 (aldesleukin) elicits anti-tumor immunity and is approved for the treatment of renal cell carcinoma and melanoma based on durable complete remissions . XTX202, a third generation, tumor-selective IL-2, inhibits tumor growth and is well tolerated in repeat dose studies in NHPs at high doses . GLP toxicity studies with XTX202 are underway and first-in-human studies are expected to initiate this year . XTX202 has the potential to be a best-in-class IL-2 immunotherapy by expanding the curative anti-tumor activity of IL-2 while minimizing dose-limiting toxicities.