Clinical trial · Interventional
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
NCT07688577CI-TRIAL-00117135not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic NSCLC - Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XTX501 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1 - XTX501 Monotherapy Dose Escalation and Backfill
- description
- 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).
- interventionNames
- Drug: XTX501
- type
- EXPERIMENTAL
- label
- Phase 2- XTX501 Monotherapy Dose Expansion in metastatic NSCLC
- description
- Phase 2 will further evaluate the efficacy of the selected recommended Phase 2 dose(s) in participants with metastatic NSCLC.
- interventionNames
- Drug: XTX501
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.