XTX301 in Patients With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a first-in-human, multicenter, Phase 1, open-label study designed to evaluate the safety and tolerability of XTX301 as monotherapy in patients with advanced solid tumors.

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

Details

• Lead Sponsor: Xilio Development, Inc.

Criteria

Inclusion Criteria:

• Disease Criteria: Part 1A - Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit, or standard therapy is not available.

Part 1B- Any histologically or cytologically confirmed solid tumor malignancy among the tumor types outlined below, that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit, or standard therapy is not available. Patients with the following tumor types are eligible for Part 1B: melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, triple-negative breast cancer (TNBC), MSI-H/dMMR colorectal cancer, MSI-H/dMMR endometrial cancer, prostate cancer, ovarian cancer, pancreatic cancer, and microsatellite stable colorectal cancer.

• ECOG performance status of 0-2

• Adequate organ function

• Tumor tissue samples: Part 1A: archival tumor tissue available or provide a fresh tumor biopsy. Part 1B: patients must have lesions amenable to biopsy and be willing and able to provide fresh tumor biopsies before and after initiation of treatment

Exclusion Criteria:

• Prior treatment with IL-12 therapy (any form, e.g. recombinant human, prodrug, intratumoral, etc.)