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New drug combo tested for tough cancers

NCT ID NCT05277051

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called remzistotug, alone or with other cancer drugs, in 152 people with advanced solid tumors that have not responded to standard treatments. The main goal is to check safety and find the right dose. It is not yet known if the drug will shrink tumors or improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remzistotug (alone or with dostarlimab, belrestotug, nelistotug, or GSK5764227)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is a very early (Phase 1) trial focused on safety and dosing, not on proving the drug works. It is small (152 people) and may not lead to an approved treatment.

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

152 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Aug 2027

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: * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: * Is not a woman of childbearing potential (WOCBP) or * Is a WOCBP and using a contraceptive method that is highly effective with a failure rate of less than (\<)1 percent (\[%\] per year), during the intervention period and for specified time after end of study treatment. * A WOCBP must have a negative highly sensitive pregnancy test within 24-48 hours before the first dose of study intervention. * Requirement for Arm I only: Male participants agree to use contraception and for their female partner to use contraception, if applicable. * Histological or cytological documentation of loco-regionally recurrent solid tumors where curative treatment options have been exhausted, or metastatic solid tumors; types as follows: * head and neck squamous cell carcinoma (HNSCC) * non-small-cell lung cancer (NSCLC) * breast cancer (BC) * clear cell renal cell cancer (ccRCC) * gastric cancer (GC) * colorectal cancer (CRC) * endometrial cancer (EC) * epithelial ovarian, fallopian tube, and primary peritoneal cancers- 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. * Measurable disease per RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Life expectancy of at least 12 weeks. * Adequate organ function, as defined in the protocol. * For participants enrolled in a PK/PD cohort, participant agrees to a fresh tumor biopsy during Screening and at approximately 6-weeks after treatment initiation. Exclusion Criteria: * Prior treatment with the following therapies (specified time periods are from last dose of prior treatment to first dose of study intervention): * Any therapy directed against Polio virus receptor (PVR)-related immunoglobulin domain-containing (PVRIG) (COM701 or other anti-PVRIG monoclonal antibody \[mAb\]) or other cluster of differentiation (CD)226 axis receptor (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibition motif domain \[TIGIT\] or CD96) at any time. * For Arm I only, prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents. * Other prior immunotherapy, chemotherapy, targeted therapy, biological therapy or radiation therapy within specified periods as defined in the protocol. * Investigational therapy: if the participant has participated in a clinical study and has received an investigational product within 4 weeks or 5 half-lives of the investigational product (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 * History of myocarditis of any grade during a previous treatment with immunotherapy * Toxicity related to prior treatment that has not resolved to less than or equal to (\<=) Grade 1. Non clinically relevant Grade 2 toxicities, not constituting a safety risk by investigator judgment are allowed. * Participant has a known additional malignancy that progressed or required active treatment within the last 2 years.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm clear cell renal carcinoma colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm fallopian tube cancer gastric cancer gastric neoplasm head and neck squamous cell carcinoma neoplasm Neoplasm Metastasis non-small cell lung carcinoma ovarian carcinoma primary peritoneal carcinoma renal cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Neoplasms

Contacts and locations

Locations

  • GSK Investigational Site

    San Francisco, California, 94158, United States

  • GSK Investigational Site

    Charlotte, North Carolina, 28204, United States

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19111, United States

  • GSK Investigational Site

    Dallas, Texas, 75230, United States

  • GSK Investigational Site

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    Salt Lake City, Utah, 84112, United States

  • GSK Investigational Site

    Nedlands, Western Australia, 6009, Australia

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    Chengdu, 610041, China

  • GSK Investigational Site

    Jinan, 250117, China

  • GSK Investigational Site

    Shanghai, 200126, China

  • GSK Investigational Site

    Wuhan, 430022, China

  • GSK Investigational Site

    Dijon, 21000, France

  • GSK Investigational Site

    Lille, 59000, France

  • 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, 03722, South Korea

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Madrid, 28040, Spain

  • GSK Investigational Site

    Madrid, 28050, Spain

  • GSK Investigational Site

    Málaga, 29010, Spain

  • GSK Investigational Site

    Manchester, M20 4BX, United Kingdom

  • GSK Investigational Site

    Sutton, SM2 5PT, United Kingdom

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