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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

Sponsor: Xilio Development, Inc. · Participants: 180 · Started: Oct 21, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07688577

Locations in the U.S.

OhioInvestigator Site, Canton
TexasInvestigator Site, Fort Worth
VirginiaInvestigator Site, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.