XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors

Starting soon · Phase 1/Phase 2

Conditions studied: Metastatic NSCLC - Non-Small Cell Lung Cancer, Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT07688577

Run by

Xilio Development, Inc.

People needed

140

Starts

2026-08-01

Expected to finish

2029-11-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Measurable disease at baseline per RECIST v1.1
• ECOG performance status of 0 or 1
• Adequate organ function
• Metastatic NSCLC:
• Must have histologically confirmed metastatic NSCLC.
• Tumor must have been assessed for EGFR and ALK per local standard of practice; patients with these driver mutations are excluded.
• Patients with tumors known to have the following alterations are excluded: ROS1, RET, MET, HER-2, NTRK 1/2/3.
• Patients must have previously derived clinical benefit from a PD-1/PD-L1 inhibitor or PD-1/PDL-1 bispecific without progression for at least 6 months.

You may not qualify if…

• Prior treatment with IL-2
• History of significant pulmonary disease
• History of clinically significant cardiovascular disease
• Active CNS metastases
• Pregnant or breastfeeding
• In Phase 1, participants with select additional solid tumor types may be enrolled.

Full record on ClinicalTrials.gov

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