Study on XTX501 for Patients with Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors

Sponsor: Xilio Development, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07688577

This clinical trial is testing a new drug, XTX501, to see if it is safe and well-tolerated in patients with metastatic non-small cell lung cancer (NSCLC) and certain advanced solid tumors. The study will also evaluate how the drug affects the body and its potential to fight cancer.

Patient Parameters

Parameter	Options

Program Overview

This study is the first time XTX501 is being tested in humans. It involves multiple centers and is open to participants with metastatic non-small cell lung cancer (NSCLC) and certain advanced solid tumors. The main goal is to assess the safety and tolerability of XTX501 when used alone. The study will also look at how the drug behaves in the body, its effects on the immune system, and its ability to fight cancer. The study is divided into two phases: Phase 1 will determine the safest dose of XTX501, while Phase 2 will evaluate how effective the drug is at that dose.

Description

The study is divided into two main phases:

Phase 1: This phase is further divided into two parts. Part 1A will test different doses of XTX501 to find the highest dose that patients can tolerate without severe side effects. Part 1B will continue to assess the safety and cancer-fighting ability of XTX501 at doses that are being considered for further testing.
Phase 2: This phase will focus on how well XTX501 works at the selected dose from Phase 1.

Throughout the study, researchers will monitor participants for any side effects, how the drug is processed by the body, and its impact on the immune system. The study aims to gather information on the potential benefits of XTX501 for treating metastatic NSCLC and other advanced solid tumors.

Eligibility Criteria

Inclusion Criteria

Have a measurable tumor based on standard criteria.
Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Have good organ function as determined by specific medical tests.
For patients with metastatic NSCLC:
- Must have a confirmed diagnosis of metastatic NSCLC.
- Tumors must have been tested for specific genetic changes (EGFR and ALK) and not have certain other genetic alterations (ROS1, RET, MET, HER-2, NTRK 1/2/3).
- Must have previously benefited from a PD-1/PD-L1 inhibitor or similar treatment without cancer progression for at least 6 months.

Exclusion Criteria

Have had prior treatment with IL-2.
Have a history of significant lung disease.
Have a history of serious heart disease.
Have active cancer that has spread to the brain.
Be pregnant or breastfeeding.

In Phase 1, participants with certain other types of solid tumors may also be included.

Locations

FACILITY	ZIP	CITY	STATE
Investigator Site	44718	Canton	Ohio
Investigator Site	76104	Fort Worth	Texas
Investigator Site	22031	Fairfax	Virginia

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