NCT07688577 · Xilio Development, Inc.
XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors
What this study is about
This is a first-in-human, conducted at multiple hospitals, Phase 1/2, where both patients and doctors know the treatment given study designed to evaluate the safety and how well patients handle the treatment of XTX501 as treatment given alone in participants with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors.
View original scientific description
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.
Interventions
DRUG
XTX501
XTX501 monotherapy
Primary outcome measures
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Canton, Ohio
- Fort Worth, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 4, 2026 · Source of record for eligibility and locations