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

Sponsor
Xilio Development, Inc.
Study ID
NCT07688577
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumor
  • Metastatic NSCLC - Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XTX501 — DRUG
    XTX501 monotherapy

Study Details

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.

Key Dates

First listed
Jul 7, 2026
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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. Part 1B will further evaluate the safety and antitumor activity of XTX501 at dose regimens under consideration for the recommended Phase 2 dose(s).
  • 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.

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) ]

Central Contacts

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