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XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors
RecruitingPhase 1/2
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX501 in Participants With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
About the study
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.
What is being tested
- XTX501 (drug)
Sponsor: Xilio Development, Inc. · Participants: 180 · Started: Oct 21, 2026
Contact the study team
- Xilio Medical Affairs · Phone: (857) 524-2466
Official record on ClinicalTrials.gov — NCT07688577
Locations in the U.S.
| Ohio | Investigator Site, Canton |
| Texas | Investigator Site, Fort Worth |
| Virginia | Investigator Site, Fairfax |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.