XTX501 for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a first-in-human, multicenter, Phase 1/2, open-label study designed to evaluate the safety and tolerability of XTX501 as monotherapy in participants with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors.
Are You a Good Fit for This Trial?
This trial is for adults with metastatic non-small cell lung cancer or certain advanced solid tumors who have already benefited from immunotherapy for at least 6 months. Participants must be in good physical condition, have working major organs, and not have specific genetic mutations like EGFR, ALK, ROS1, RET, MET, HER-2, or NTRK.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- XTX501
Trial Overview
The study is testing a new drug called XTX501 given alone to see if it is safe and tolerable in people with advanced cancers. It’s an early-phase (Phase 1/2), open-label trial conducted at multiple centers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Phase 2 will further evaluate the efficacy of the selected recommended Phase 2 dose(s) in participants with metastatic NSCLC. Up to 80 participants may be enrolled
Part 1A will examine XTX501 monotherapy in a Bayesian Optimal Interval design to determine the maximum tolerated dose up to 10 dose regimens. Up to 60 participants may be enrolled. Part 1B will further evaluate the safety and antitumor activity of XTX501 at dose regimens under consideration for the recommended Phase 2 dose(s). Up to 40 participants may be enrolled
Find a Clinic Near You
Who Is Running the Clinical Trial?
Xilio Development, Inc.
Lead Sponsor
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