XTX101 Monotherapy and XTX101 and Pembrolizumab Combination Therapy in Patients With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2026-03-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of XTX101 as monotherapy and XTX101 and pembrolizumab combination therapy in patients with advanced solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xilio Development, Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Disease Criteria - Part 1A and 1C- 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; Part 1B - Any histologically or cytologically confirmed solid tumor malignancy for which anti-PD-1 or anti-PD-L1 treatment is approved and has progressed on or after prior anti-PD-1 or anti-PD-L1 therapy. Part 2- histologically or cytologically confirmed unresectable or metastatic melanoma that has not been treated with prior anti-PD-1 or anti-PD-L1 therapy

• ECOG performance status of 0 or 1

• Adequate organ function

• Part 2 only: measurable disease per iRECIST

Exclusion Criteria:

• Received prior treatment with anti-CTL-4 therapy

• Received prior immune-checkpoint therapy and experienced Grade 3 or greater toxicity lasting greater than 6 weeks

• Received prior systemic anticancer therapy within 4 weeks prior to study treatment

• Received prior radiotherapy within 2 weeks prior to study treatment

• Has a diagnosis of immunodeficiency

• Has known malignancy (other than disease under study) that is progressing or has required active treatment within the past 3 years

• 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

• Has a history of severe hypersensitivity reaction (≥ Grade 3) to any study intervention and/or any of its excipients

• Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

• Part 2 only: has ocular melanoma

• Part 2 only: has received prior anti-PD-1/L-1 therapy