Metastatic NSCLC - Non-Small Cell Lung CancerPhase 1/2NCT07688577
XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors
A Phase 1/2 study testing XTX501 in people with Metastatic NSCLC - Non-Small Cell Lung Cancer and Advanced Solid Tumor, run by Xilio Development, Inc. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic NSCLC - Non-Small Cell Lung Cancer, Advanced Solid Tumor
- What is being tested?
- XTX501
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Oct 2026to Nov 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Investigator Site
Canton, Ohio, 44718
- Recruiting
Investigator Site
Fairfax, Virginia, 22031
- Recruiting
Investigator Site
Fort Worth, Texas, 76104
About this study
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
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.
Read the 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).
- Being tested
- XTX501
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XTX501Drug
XTX501 monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 - XTX501 Monotherapy Dose Escalation and Backfill | Experimental | Part 1A will examine XTX501 monotherapy in a Bayesian Optimal Interval design to determine the maximum tolerated dose up to 10 dose regimens. Up to 60 participants may be enrolled.
Part 1B will further evaluate the safety and antitumor activity of XTX501 at dose regimens under consideration for the recommended Phase 2 dose(s). Up to 40 participants may be enrolled Receives: Drug: XTX501 |
| Phase 2- XTX501 Monotherapy Dose Expansion in metastatic NSCLC | Experimental | Phase 2 will further evaluate the efficacy of the selected recommended Phase 2 dose(s) in participants with metastatic NSCLC. Up to 80 participants may be enrolled Receives: Drug: XTX501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs) in Part 1A
Measured: 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)
Measured: Up to Safety Follow Up Period (90 [+7] days after the last dose)
Incidence of serious adverse events (Phase 1 and Phase 2)
Measured: 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)
Measured: 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)
Measured: Up to Safety Follow Up Period (90 [+7] days after the last dose)
Secondary outcomes (12)
Investigator-assessed objective response rate (ORR) per RECIST v1.1 (Phase 1)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Maximum observed plasma concentration (Cmax) (Phase 1 and Phase 2)
Measured: 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)
Measured: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Trough concentrations (Ctrough) (Phase 1 and Phase 2)
Measured: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Area under the curve (AUC) (Phase 1 and Phase 2)
Measured: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Half-life (t1/2) (Phase 1 and Phase 2)
Measured: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Systemic clearance (CL) (Phase 1 and Phase 2)
Measured: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Volume of distribution (Vd) (Phase 1 and Phase 2)
Measured: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start21 Oct 2026
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic NSCLC - Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xilio Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688577
- Sponsor's protocol ID
- XTX501-01/02-001
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07688577
- Acronym / sponsor ID
- XTX501-01/02-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Xilio Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2026 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - XTX501 Monotherapy Dose Escalation and Backfill | Experimental | Drug: XTX501Part 1A will examine XTX501 monotherapy in a Bayesian Optimal Interval design to determine the maximum tolerated dose up to 10 dose regimens. Up to 60 participants may be enrolled. Part 1B will further evaluate the safety and antitumor activity of XTX501 at dose regimens under consideration for the recommended Phase 2 dose(s). Up to 40 participants may be enrolled |
| Phase 2- XTX501 Monotherapy Dose Expansion in metastatic NSCLC | Experimental | Drug: XTX501Phase 2 will further evaluate the efficacy of the selected recommended Phase 2 dose(s) in participants with metastatic NSCLC. Up to 80 participants may be enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Measurable disease at baseline per RECIST v1.1
- ECOG performance status of 0 or 1
- Adequate organ function
- Metastatic NSCLC:
Key exclusion criteria (6 listed)
- Prior treatment with IL-2
- History of significant pulmonary disease
- History of clinically significant cardiovascular disease
- Active CNS metastases
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XTX501XTX501 monotherapy | Drug | Phase 1 - XTX501 Monotherapy Dose Escalation and Backfill, Phase 2- XTX501 Monotherapy Dose Expansion in metastatic NSCLC |
Primary outcome
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)
12 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XTX501 in people with Metastatic NSCLC - Non-Small Cell Lung Cancer and Advanced Solid Tumor, run by Xilio Development, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xilio Medical Affairs ((857) 524-2466, medicalaffairs@xiliotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.