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New hope for Hard-to-Treat cancers: experimental drug combo enters human trials

NCT ID NCT03843359

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

97 people

The number who actually took part.

Started

Mar 2019

Finished

Jan 2026

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: * 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.

Bites and Stings neoplasm

As listed by the trial registrant

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

Contacts and locations

Locations

  • GSK Investigational Site

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    Melbourne, Victoria, 3000, Australia

  • GSK Investigational Site

    Toronto, Ontario, M5G 1Z9, Canada

  • GSK Investigational Site

    Bordeaux, 33076, France

  • GSK Investigational Site

    Villejuif, 94805, France

  • GSK Investigational Site

    Tokyo, 104-0045, Japan

  • GSK Investigational Site

    Tokyo, 135-8550, Japan

  • GSK Investigational Site

    Amsterdam, 1066 CX, Netherlands

  • GSK Investigational Site

    Amsterdam, 1081 HV, Netherlands

  • GSK Investigational Site

    Seoul, 03080, South Korea

  • GSK Investigational Site

    Madrid, 28040, Spain

  • GSK Investigational Site

    Madrid, 28050, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.