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

NCT07688577 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: XTX501-01/02-001
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (5)

• Incidence of Dose Limiting Toxicities (DLTs) in Part 1A

  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)

  Up to Safety Follow Up Period (90 [+7] days after the last dose)

• Incidence of serious adverse events (Phase 1 and Phase 2)

  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)

  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)

  Up to Safety Follow Up Period (90 [+7] days after the last dose)

Secondary Outcomes (12)

• Investigator-assessed objective response rate (ORR) per RECIST v1.1 (Phase 1)

  Up to Safety Follow Up Period (90 [+7] days after the last dose)

• Investigator-assessed duration of response (DOR) per RECIST v1.1 (Phase 1 and Phase 2)

  Up to Safety Follow Up Period (90 [+7] days after the last dose)

• Investigator-assessed disease control rate (DCR) per RECIST v1.1 (Phase 2)

  Up to Safety Follow Up Period (90 [+7] days after the last dose)

• Investigator-assessed progression free survival (PFS) per RECIST v1.1 (Phase 2)

  Up to Safety Follow Up Period (90 [+7] days after the last dose)

• Incidence and persistence of antidrug antibodies (ADAs) (Phase 1 and Phase 2)

  Up to End of Treatment (within 10 days of the decision to discontinue XTX501)

Study Arms (2)

Phase 1 - XTX501 Monotherapy Dose Escalation and Backfill

EXPERIMENTAL

Part 1A will examine XTX501 monotherapy in a Bayesian Optimal Interval design to determine the maximum tolerated dose up to 10 dose regimens. Part 1B will further evaluate the safety and antitumor activity of XTX501 at dose regimens under consideration for the recommended Phase 2 dose(s).

Drug: XTX501

Phase 2- XTX501 Monotherapy Dose Expansion in metastatic NSCLC

EXPERIMENTAL

Phase 2 will further evaluate the efficacy of the selected recommended Phase 2 dose(s) in participants with metastatic NSCLC.

Drug: XTX501

Interventions

XTX501 DRUG

XTX501 monotherapy

Phase 1 - XTX501 Monotherapy Dose Escalation and Backfill; Phase 2- XTX501 Monotherapy Dose Expansion in metastatic NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xilio Development, Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xilio Medical Affairs

CONTACT

(857) 524-2466; medicalaffairs@xiliotx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share