XTX501 in people with metastatic NSCLC and advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label Phase 1/2 trial of XTX501 given as a single agent. The study aims to characterize safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and anti-tumor activity. Phase 1 uses a Bayesian design to establish a maximum tolerated dose and then to evaluate safety and activity at dose levels under consideration for the recommended Phase 2 dose. Phase 2 will further assess efficacy at the chosen dose(s). Enrollment includes participants with measurable disease and adequate organ function, who have previously benefited from a PD-1/PD-L1 blocker, and excludes certain driver mutations, prior IL-2 therapy, and other comorbid conditions. In addition to NSCLC, select other advanced solid tumors may enroll in Phase 1.

Why it matters

Who can join: the full rules

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.

Where it's running

• Investigator Site
  Canton, Ohio, United States Recruiting
• Investigator Site
  Fort Worth, Texas, United States Recruiting
• Investigator Site
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Xilio Medical Affairs
• Email: medicalaffairs@xiliotx.com
• Phone: (857) 524-2466

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.