Lung Cancer Trials Ask AI to find trials
RecruitingPhase 1 / Phase 2NCT07688577
Official study title

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

Study summary

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.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedXTX501

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 2, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Xilio Development, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Xilio Development, Inc.
Interventions being studied
Drug: XTX501
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Investigator SiteCanton, Ohio
  • Investigator SiteFort Worth, Texas
  • Investigator SiteFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 2, 2026. Always confirm current availability with the study team.

View original record ↗