New drug combo targets tough tumors
NCT ID NCT05840224
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 182 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Asan Medical Center
Seoul, 05505, South Korea
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Chang Gung Memorial Hospital Linkuo Branch of the Chang Gung Medical Foundation
Taoyuan, 333, Taiwan
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Clinica Universidad de Navarra- Unidad Central de Ensayos Clinicos
Pamplona, 31008, Spain
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Hospital Universitari Vall D'Hebron- Oncology Service
Barcelona, 08035, Spain
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NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1
Barcelona, 08023, Spain
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National Taiwan University Hospital
Taipei, 100229, Taiwan
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START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I
Madrid, 28050, Spain
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START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I
Madrid, 28040, Spain
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Samsung Medical Center
Seoul, 06351, South Korea
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Severance Hospital, Yonsei University Health Systems
Seoul, 06273, South Korea
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St Bartholomew's Hospital
London, E1 1FR, United Kingdom
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Taichung Veterans General Hospital
Taichung, 40705, Taiwan
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The Ottawa Hospital
Ottawa, K1H 8L6, Canada
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The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
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The University of Washington/FHCC
Seattle, Washington, 98109, United States
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University Health Network, Princess Margaret Cancer Centre
Toronto, M5G 1Z5, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers