New hope for Hard-to-Treat cancers: experimental drug combo enters human trials
NCT ID NCT03843359
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This early-stage study tests a new drug called GSK3745417, given alone or with another drug (dostarlimab), in about 97 adults with advanced solid tumors that have stopped responding to standard treatments. The main goal is to find a safe dose and check for side effects. This is a first-in-human trial, so the drug's effectiveness is not yet known.
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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97 people
The number who actually took part.
- Started
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Mar 2019
- Finished
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Jan 2026
- 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: * Participant must be more than or equal to (\>=)18 years of age. * Participants with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established. * Histological or cytological documentation of an advanced solid tumor. * Participants must provide a fresh biopsy. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Adequate organ function per protocol specifications. * Male or female participants. * Female participants are eligible to participate if they are not breastfeeding or pregnant (or intend to breastfeed or become pregnant). Women of childbearing potential must use a highly effective method of contraception. * Capable of giving signed informed consent. Exclusion Criteria: * 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 within 28 days before the first dose of study treatment. * Current unstable liver or biliary disease. * History of vasculitis at any time prior to study treatment. * Evidence or history of significant active bleeding or coagulation disorder. * Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C. * QT duration corrected for heart rate by Fridericia's formula (QTcF) more than (\>)450 milliseconds (msec) or QTcF \>480 msec for participants with bundle branch block. * Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction. * Recent history of allergen desensitization therapy within 4 weeks of starting study treatment. * History or evidence of cardiovascular (CV) risk * Recent (within the past 6 months) history of symptomatic pericarditis. * History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis. * History of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions. * Prior treatment with the following agents: 1. Stimulator of Interferon Genes (STING) agonist at any time. 2. Anticancer therapy or investigational therapy or used an investigational device within 28 days or 5 half-lives of the drug, whichever is shorter. 3. Checkpoint inhibitors, including Programmed death receptor-1 (PD-1), Programmed death Ligand-1 (PD-L1), PD-L2 and Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors within 28 days. 4. Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. * Pregnant and/or breast feeding participants or those who plan to become pregnant and/or breastfeed. * Receipt of any live vaccine within 30 days of the start of study treatment. * Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation. * Major surgery less than or equal to (\<=)28 days before the first dose of study treatment. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment. * Participants with signs/symptoms suggestive of Coronavirus Disease-2019 (COVID-19) within 14 days of study entry, or with known exposure to COVID-19 within 14 days prior to study entry. * Participants are excluded from Part 2A of the study if they have known hypersensitivity to dostarlimab or associated excipients.
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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
Houston, Texas, 77030, United States
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GSK Investigational Site
Melbourne, Victoria, 3000, Australia
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GSK Investigational Site
Toronto, Ontario, M5G 1Z9, Canada
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GSK Investigational Site
Bordeaux, 33076, France
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GSK Investigational Site
Villejuif, 94805, France
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GSK Investigational Site
Tokyo, 104-0045, Japan
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GSK Investigational Site
Tokyo, 135-8550, Japan
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GSK Investigational Site
Amsterdam, 1066 CX, Netherlands
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GSK Investigational Site
Amsterdam, 1081 HV, Netherlands
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GSK Investigational Site
Seoul, 03080, South Korea
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GSK Investigational Site
Madrid, 28040, Spain
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GSK Investigational Site
Madrid, 28050, Spain
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