NCT07688577RecruitingPhase 1/2
XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX501 in Participants With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 21 Oct 2026
- Primary completion date
- 30 Nov 2029
- Lead sponsor
- Xilio Development, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT07688577
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 180
- From 21 Oct 2026 to the primary completion date, 30 Nov 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with IL-2
Other illness
- History of significant pulmonary disease
- History of clinically significant cardiovascular disease
Other
- Active CNS metastases
- Pregnant or breastfeeding
- In Phase 1, participants with select additional solid tumor types may be enrolled.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigator Site Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.