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New hope for tumors that beat immunotherapy? early trial launches

NCT ID NCT06270706

Disease control Sponsor: Pliant Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug (PLN-101095) alone or with pembrolizumab in adults whose advanced solid tumors have stopped responding to standard immunotherapy. About 124 participants will receive the treatment to check safety and early signs of tumor shrinkage. The goal is to find a safe dose and see if the combination can re-sensitize tumors to immunotherapy.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Jun 2030

An estimate. End dates often move.

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. Has histologically or cytologically confirmed advanced or metastatic solid tumor 2. Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies 3. Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only) 4. Must have subsequently developed radiographic disease progression while receiving anti-PD-1 or anti-PD-L1 treatment or within ≤12 weeks after the last dose of such treatment 5. At least 1 measurable lesion, as defined by RECIST v1.1 6. Estimated survival of ≥3 months 7. Have adequate bone marrow and organ function. 8. A female participant is eligible to participate if she is not pregnant, not breastfeeding Exclusion Criteria: 1. Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab 2. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years 3. Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy 4. Has undergone major surgery within 4 weeks prior to the first dose of study treatment or has not adequately recovered from surgery or related complications 5. Has a diagnosis of immunodeficiency or use of systemic steroids \>10 mg/day 6. Has an active autoimmune disease that has required systemic treatment in the past 2 years 7. Has known active CNS metastases (brain and/or leptomeningeal metastases) 8. Has significant cardiac disease 9. Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C) 10. Has received a live or live-attenuated vaccine within 30 days or a non-live vaccine within 7 days prior to the first dose of PLN-101095

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Conditions

The condition(s) this trial relates to.

anus neoplasm cholangiocarcinoma colorectal neoplasm endometrium neoplasm melanoma metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma ovarian cancer renal cell carcinoma transitional cell carcinoma triple-negative breast carcinoma

As listed by the trial registrant

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

Advanced or metastatic solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    11 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Carolina Cancer Research Center

    RECRUITING

    Wilson, North Carolina, 27893, United States

    Contact Email: •••••@•••••

  • NEXT Austin

    RECRUITING

    Austin, Texas, 78758, United States

    Contact Email: •••••@•••••

  • NEXT Houston

    RECRUITING

    Houston, Texas, 77054, United States

    Contact Email: •••••@•••••

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

    Contact Email: •••••@•••••

  • START Center for Clinical Research

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

    Contact Email: •••••@•••••

  • START New Jersey

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

    Contact Email: •••••@•••••

  • START New York Long Island LLC

    RECRUITING

    Lake Success, New York, 11042, United States

    Contact Email: •••••@•••••

  • South Texas Accelerated Research Therapeutics (START)

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

    Contact Email: •••••@•••••

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Email: •••••@•••••

  • Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

    Contact Email: •••••@•••••

  • Yale University

    ACTIVE_NOT_RECRUITING

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.