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New drug combo tested for Hard-to-Treat cancers

NCT ID NCT04446351

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage study tests a new experimental drug called GSK6097608, given alone or with other cancer medicines, in people with advanced solid tumors that have spread or come back. The main goals are to check safety, find the right dose, and see if the drug shrinks tumors. About 107 adults with various advanced cancers are taking 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

107 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Dec 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.

Inclusion Criteria: * Adults 18 years of age or older (or \>=20 years of age in Arm-A Japan, Arm-D Japan, Arm E-Japan, Arm F-Japan, and Arm G-Japan) * Female participants of childbearing potential must agree to use a highly effective form of contraception * Histological or cytological documentation of locally advanced, recurrent, or metastatic solid malignancy. Enrollment in PK/PD cohorts will be restricted to participants with histologically or cytologically confirmed diagnosis of 1 or more of the following: non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), endometrial cancer (EC), colorectal cancer (CRC) (including specified molecular subtypes of these) or an alternative immunogenic tumor type with medical monitor approval * Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists * Participants in a PK/PD cohort (Arms A, B, E and F) must provide fresh tumor biopsies. Biopsies are not required from participants enrolled in Arm D, Arm E, (non-PK/PD cohorts only), Arm F (non-PK/PD cohort only), Arm G or any participant enrolled in mainland China * Eastern cooperative oncology group (ECOG) performance status (PS) 0 to 1 * Life expectancy of at least 12 weeks * Adequate organ function as determined by laboratory assessments * Adequate cardiac ejection fraction as measured by echocardiogram * Arm A-Japan, Arm D-Japan, Arm E-Japan, Arm F-Japan, and Arm G-Japan only: lives in Japan and is racially Japanese, defined as all biological grandparents being Japanese * Arm A-China, Arm B-China, Arm D-China, Arm E-China and Arm F-China only (excluding PK/PD cohorts in Arm E and Arm F): is of Chinese descent and lives in China * Arm D, Arm E, Arm F, and Arm G only: has been deemed suitable for assigned treatment based on assessment by the investigator Exclusion Criteria: * Prior anti-cancer treatment including investigational agents, immune checkpoint inhibitors, chemotherapy, targeted therapy, and biological therapy: within 4 weeks or 5 half-lives of the drug, whichever is shorter * Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation * Toxicity from previous anticancer treatment, including; greater than or equal to (\>=) Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that led to treatment discontinuation; or toxicity related to prior treatment that has not resolved; or history of myocarditis of any grade during a previous treatment with immunotherapy * Known additional malignancy that progressed or required active treatment within the last 2 years * Uncontrolled or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis * Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years * Concurrent medical condition requiring the use of systemic immunosuppressive treatment * Cirrhosis or current unstable liver or biliary disease per investigator assessment * Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) * Prolonged QT as measured by electrocardiogram * Allergen desensitization therapy within 4 weeks of starting study intervention * History of hypersensitivity to any of the study interventions or their excipients * Has a history or evidence of cardiac abnormalities within the 6 months prior to enrolment * Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions * History of idiopathic pulmonary fibrosis; interstitial lung disease; organizing pneumonia; noninfectious pneumonitis that required steroids, or evidence of active, noninfectious pneumonitis * Pregnant or lactating woman * Receipt of live vaccine within 30 days of the start of study intervention * Receipt of transfusion of blood products or administration of colony-stimulating factors within 14 days before the first dose of study intervention * Major surgery less than 4 weeks before the first dose of study intervention * Known drug or alcohol abuse

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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

  • GSK Investigational Site

    Los Angeles, California, 90025, United States

  • GSK Investigational Site

    Boston, Massachusetts, 02215, United States

  • GSK Investigational Site

    Dallas, Texas, 75230, United States

  • GSK Investigational Site

    Houston, Texas, 77030-4009, United States

  • GSK Investigational Site

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 1Z5, Canada

  • GSK Investigational Site

    Chiba, 277-8577, Japan

  • GSK Investigational Site

    Tokyo, 104-0045, Japan

  • GSK Investigational Site

    Seoul, 03080, South Korea

  • GSK Investigational Site

    Seoul, 06351, South Korea

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