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New drug XTX202 tested in patients with advanced cancers

NCT ID NCT05052268

Disease control Sponsor: Xilio Development, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called XTX202 in 95 people with advanced solid tumors that had not responded to standard treatments. The goal was to check safety, find the right dose, and see if the drug could shrink tumors. The trial is now complete.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XTX202
What this could lead to
If successful, XTX202 could offer a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 95 participants, so results may not apply to all patients. Side effects and lack of tumor shrinkage are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

95 people

The number who actually took part.

Started

Jan 2022

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Disease Criteria * Phase 1, Part 1a: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available * Phase 1, Part 1b: Histologically or cytologically confirmed solid tumor malignancy with one of the following tumor histologies: RCC of clear cell histology only, melanoma, squamous cell skin carcinoma, ovarian cancer, non-small cell lung cancer. Those patients who previously received immunotherapy must have derived benefit from this treatment. Additionally, patients with any of the above histologies in an advanced setting who plan to undergo debulking surgery or oligometastasectomy may be eligible to receive 2 cycles of XTX202 treatment in a "window of opportunity" subcohort". * Phase 2, Part 2a: Patients with metastatic RCC who have previously been treated with an anti-PD-1 and a TKI, per local and institutional SOC. Patients must have progressed on treatment with an anti-PD-1 mAb administered either as monotherapy or in combination with other therapies * Phase 2, Part 2b: Patients with unresectable or metastatic melanoma who have previously been treated with at least 1 prior line of therapy in the recurrent or metastatic setting. Prior therapy must have included an anti-PD-1 alone or in combination per local and institutional standard of care, and patient must have progressed on checkpoint inhibitor therapy. Patients with BRAF V600-activating mutation must have previously received targeted therapy per local and institutional standard of care. 2. ECOG performance status of 0 or 1 3. Adequate organ function 4. Part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment. Exclusion Criteria: 1. Received prior treatment with IL-2 therapy 2. History of clinically significant pulmonary disease 3. History of clinically significant cardiovascular disease 4. Has a diagnosis of immunodeficiency 5. Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs 6. Has an active infection requiring systemic therapy within 4 weeks prior to study treatment

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Conditions

The condition(s) this trial relates to.

melanoma neoplasm non-small cell lung carcinoma ovarian cancer renal cell carcinoma skin squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor

Contacts and locations

Locations

  • Atlantic Health System/Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • HealthPartners Cancer Center at Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Hoag Memorial Hospital Presbyterian- Newport Beach

    Newport Beach, California, 92663, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • Rutgers Cancer Institute of NJ

    New Brunswick, New Jersey, 08903, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • The Ohio State University Wexner Medical Center James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • UPMC Hillman Cancer Center Pavilion

    Pittsburgh, Pennsylvania, 15213, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

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