New drug combo tested for Hard-to-Treat cancers
NCT ID NCT04446351
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.
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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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107 people
The number who actually took part.
- Started
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Jun 2020
- Expected to finish
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Dec 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.
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
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GSK Investigational Site
Los Angeles, California, 90025, United States
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GSK Investigational Site
Boston, Massachusetts, 02215, United States
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GSK Investigational Site
Dallas, Texas, 75230, United States
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GSK Investigational Site
Houston, Texas, 77030-4009, United States
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GSK Investigational Site
San Antonio, Texas, 78229, United States
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GSK Investigational Site
Ottawa, Ontario, K1H 8L6, Canada
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GSK Investigational Site
Toronto, Ontario, M5G 1Z5, Canada
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GSK Investigational Site
Chiba, 277-8577, Japan
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GSK Investigational Site
Tokyo, 104-0045, Japan
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GSK Investigational Site
Seoul, 03080, South Korea
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GSK Investigational Site
Seoul, 06351, South Korea
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Other studies related to the condition(s) this trial covers.
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