XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XTX501.
- Who it may be relevant to
- Registry conditions: Metastatic NSCLC - Non-Small Cell Lung Cancer, Advanced Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, PK, pharmacodynamics, immunogenicity, and antitumor activity of XTX501, an investigational bispecific PD-1/masked IL-2 in participants with metastatic NSCLC and select advanced solid tumors.
Phase 1, Part 1A will examine XTX501 monotherapy in a Bayesian Optimal Interval design to determine the maximum tolerated dose up to 10 dose regimens.
Phase 1, Part 1B will further evaluate the safety and antitumor activity of XTX501 at dose regimens under consideration for the recommended Phase 2 dose(s).
Phase 2 will further evaluate the efficacy of the selected recommended Phase 2 dose(s).
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)]
Secondary outcome measures (12)
- Investigator-assessed objective response rate (ORR) per RECIST v1.1 (Phase 1) [Time frame: Up to Safety Follow Up Period (90 [+7] days after the last dose)]
- Investigator-assessed duration of response (DOR) per RECIST v1.1 (Phase 1 and Phase 2) [Time frame: Up to Safety Follow Up Period (90 [+7] days after the last dose)]
- Investigator-assessed disease control rate (DCR) per RECIST v1.1 (Phase 2) [Time frame: Up to Safety Follow Up Period (90 [+7] days after the last dose)]
- Investigator-assessed progression free survival (PFS) per RECIST v1.1 (Phase 2) [Time frame: Up to Safety Follow Up Period (90 [+7] days after the last dose)]
- Incidence and persistence of antidrug antibodies (ADAs) (Phase 1 and Phase 2) [Time frame: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
- Maximum observed plasma concentration (Cmax) (Phase 1 and Phase 2) [Time frame: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
- Time of maximum observed concentration (Tmax) (Phase 1 and Phase 2) [Time frame: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
- Trough concentrations (Ctrough) (Phase 1 and Phase 2) [Time frame: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
- Area under the curve (AUC) (Phase 1 and Phase 2) [Time frame: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
- Half-life (t1/2) (Phase 1 and Phase 2) [Time frame: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
- Systemic clearance (CL) (Phase 1 and Phase 2) [Time frame: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
- Volume of distribution (Vd) (Phase 1 and Phase 2) [Time frame: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07688577 · XTX501-01/02-001