Recruiting
Phase 1
Phase 2

XTX501

Sponsor:

Xilio Development, Inc.

Code:

NCT07688577

Conditions

Metastatic NSCLC - Non-Small Cell Lung Cancer

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

XTX501

Study Details

Brief 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.

Conditions

Metastatic NSCLC - Non-Small Cell Lung Cancer

Advanced Solid Tumor

Study ID

NCT07688577

Start date

Oct 21, 2026

Status verified date

Oct, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1 - XTX501 Monotherapy Dose Escalation and Backfill

Part 1A will examine XTX501 monotherapy in a Bayesian Optimal Interval design to determine the maximum tolerated dose up to 10 dose regimens. Up to 60 participants may be enrolled.

Part 1B will further evaluate the safety and antitumor activity of XTX501 at dose regimens under consideration for the recommended Phase 2 dose(s). Up to 40 participants may be enrolled

experimental: Phase 2- XTX501 Monotherapy Dose Expansion in metastatic NSCLC

Phase 2 will further evaluate the efficacy of the selected recommended Phase 2 dose(s) in participants with metastatic NSCLC. Up to 80 participants may be enrolled

Interventions

XTX501

XTX501 monotherapy

Primary outcome measure

  • Incidence of Dose Limiting Toxicities (DLTs) in Part 1A [ Time Frame: Cycle 1 Day 1 up to just prior to the second dose of study drug (approximately 21 days) ]
  • Incidence of treatment-emergent adverse events (Phase 1 and Phase 2) [ Time Frame: Up to Safety Follow Up Period (90 [+7] days after the last dose) ]
  • Incidence of serious adverse events (Phase 1 and Phase 2) [ Time Frame: Up to Safety Follow Up Period (90 [+7] days after the last dose) ]
  • Incidence of significant change from baseline in clinical laboratory values (Phase 1 and Phase 2) [ Time Frame: Up to Safety Follow Up Period (90 [+7] days after the last dose) ]
  • Investigator-assessed objective response rate (ORR) per RECIST v1.1 (Phase 2) [ Time Frame: Up to Safety Follow Up Period (90 [+7] days after the last dose) ]

Central Contacts and Locations

Central contacts

Xilio Medical Affairs

(857) 524-2466medicalaffairs@xiliotx.com

Locations

Investigator Site

Recruiting

Canton, Ohio, United States, 44718

Investigator Site

Recruiting

Fort Worth, Texas, United States, 76104

Investigator Site

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Xilio Development, Inc.

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Xilio Development, Inc. on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.