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New drug combo targets tough tumors

NCT ID NCT05840224

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug called GS-4528, given alone or with another cancer drug (anti-PD-1), in adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety and find the best dose. About 182 participants will take part.

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 182 people

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

Started

May 2023

Expected to finish

Oct 2026

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.

Key Inclusion Criteria: * Documented disease: * Phase 1a dose escalation and backfill cohorts; Phase 1b dose escalation: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy. * Phase 1a dose expansion: Individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy. * Eastern Cooperative Oncology Group performance status 0 or 1. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. * Adequate organ function. * Individuals of childbearing potential who engage in heterosexual intercourse must agree to use method(s) of contraception. * Tissue requirements: * Phase 1a dose escalation, Phase 1a dose expansion, and Phase 1b dose escalation: Must provide pre-treatment adequate tumor tissue sample prior to enrolment. * Phase 1a backfill cohorts: Individuals must have fresh pre-treatment and on-treatment biopsy for biomarker analysis. * Life expectancy ≥ 3 months. Key Exclusion Criteria: * Positive serum pregnancy test or lactating female. * Prohibited concurrent anticancer therapy listed in the protocol. * Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: major surgery (\<28 days), immunotherapy or biologic therapy (\< 28 days), chemotherapy (\< 21 days), targeted small molecule therapy (\< 14 days or \< 5 half-lives whichever is shorter), hormonal therapy or other adjunctive therapy (\< 14 days) or radiotherapy (\< 21 days). * Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. * Diagnosis of immunodeficiency, either primary or acquired, or systemic steroid requirement of \> 10 mg of prednisone or equivalent. * History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy. * History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study treatment. * Concurrent active second malignancy. Note: Individuals with a history of malignancy that have been completely treated, with no evidence of active cancer for 2 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence are allowed to enroll. * Have known active central nervous system (CNS) metastases and/ or carcinomatous meningitis. * Significant cardiovascular disease. * Have active serious infection requiring antibiotics. * Have active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). * History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis). * Symptomatic ascites or pleural effusion. * Live vaccines within 28 days of initiation of investigational product(s). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Chang Gung Memorial Hospital Linkuo Branch of the Chang Gung Medical Foundation

    Taoyuan, 333, Taiwan

  • Clinica Universidad de Navarra- Unidad Central de Ensayos Clinicos

    Pamplona, 31008, Spain

  • Hospital Universitari Vall D'Hebron- Oncology Service

    Barcelona, 08035, Spain

  • NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1

    Barcelona, 08023, Spain

  • National Taiwan University Hospital

    Taipei, 100229, Taiwan

  • START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I

    Madrid, 28050, Spain

  • START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I

    Madrid, 28040, Spain

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Severance Hospital, Yonsei University Health Systems

    Seoul, 06273, South Korea

  • St Bartholomew's Hospital

    London, E1 1FR, United Kingdom

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • The Ottawa Hospital

    Ottawa, K1H 8L6, Canada

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT, United Kingdom

  • The University of Washington/FHCC

    Seattle, Washington, 98109, United States

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, M5G 1Z5, Canada

More trials for these conditions

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