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New drug cocktail aims to tackle Hard-to-Treat cancers

NCT ID NCT06551142

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called Risvutatug rezetecan (Ris-Rez) in people with advanced solid tumors that have spread or cannot be removed. The study will give Ris-Rez alone or combined with other cancer drugs like chemotherapy or immunotherapy. Researchers want to see if it is safe, how the body processes it, and whether it can shrink tumors. About 845 adults with various solid tumors are being recruited.

What this could mean

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

Active substance
Risvutatug rezetecan (Ris-Rez), also known as GSK5764227
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early phase 1 trial, so the main goal is safety, not effectiveness. The drug may not shrink tumors or could cause side effects. Results may not apply to all cancer types.

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

About 845 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jun 2029

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 * Male or female participants at least 18 years of age (≥18 years) * Participants with histologically confirmed advanced/metastatic solid tumors, as defined per study phase and cohort, as follows: Phase 1a: 1. Participants with advanced/metastatic solid tumors. 2. For monotherapy dose escalation: participants must have progressed on or become intolerant to all available SOC therapies. 3. For combination dose escalation: participants must have received 3 or fewer prior lines of systemic anticancer therapy in the advanced/metastatic setting * Has at least 1 target lesion per RECIST 1.1, as determined by the investigator. * Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose. * Has adequate organ function. * Where available, participants should provide a formalin fixed and paraffin embedded (FFPE) tumor sample from the most recent biopsy of primary cancer or from a metastatic site for central testing. Exclusion criteria * Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy. * Prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents. * Primary brain tumor or evidence of brain metastasis (unless meeting the following criteria at the same time: asymptomatic; medically stable for at least 4 weeks prior to initial dosing; no steroid treatment required for at least 4 weeks prior to initial dosing; and no midline shift due to herniation); or untreated progression due to brain metastasis or primary brain tumor during or after the last treatment prior to screening; or evidence of meningeal/brainstem involvement; or evidence of spinal cord compression (detected by radiographic examination, symptomatic or not). * Any of the following cardiac examination abnormality: 1. Has QT interval, corrected for heart rate (QTc) \>450 msec or QTc \>480 msec for participants with bundle branch block. 2. Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular \[AV\] block, second-degree AV block, PR interval \>250 msec). 3. Risk factors of prolonged QTc or arrhythmia events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of any direct relative under 40 years old or any concomitant medications that prolong the QT interval. 4. Left ventricular ejection fraction (LVEF) \<50%. * Has severe, uncontrolled or active CV disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events * Participants with evidence of current ILD/non-infectious pneumonitis OR a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids OR suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging. * Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening. Participants with prior history of autoimmune disease must be discussed with the medical monitor. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary). * Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant. * Has received prior anticancer therapy within 28 days of the first dose of study intervention or having to continue these medications during the study.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    66 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Stanford, California, 94063, United States

  • GSK Investigational Site

    RECRUITING

    Denver, Colorado, 80218, United States

  • GSK Investigational Site

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • GSK Investigational Site

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • GSK Investigational Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • GSK Investigational Site

    RECRUITING

    Detroit, Michigan, 48201, United States

  • GSK Investigational Site

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • GSK Investigational Site

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • GSK Investigational Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • GSK Investigational Site

    RECRUITING

    Austin, Texas, 78705, United States

  • GSK Investigational Site

    RECRUITING

    Dallas, Texas, 75230, United States

  • GSK Investigational Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    RECRUITING

    Tyler, Texas, 75702, United States

  • GSK Investigational Site

    RECRUITING

    West Valley City, Utah, 84119, United States

  • GSK Investigational Site

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • GSK Investigational Site

    COMPLETED

    Rosario, S2002, Argentina

  • GSK Investigational Site

    RECRUITING

    Viedma, R8500ACE, Argentina

  • GSK Investigational Site

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • GSK Investigational Site

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M5G 1X6, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • GSK Investigational Site

    RECRUITING

    Bordeaux, 33076, France

  • GSK Investigational Site

    RECRUITING

    Lyon, 69373, France

  • GSK Investigational Site

    RECRUITING

    Villejuif, 94805, France

  • GSK Investigational Site

    RECRUITING

    Pokfulam, Hong Kong

  • GSK Investigational Site

    RECRUITING

    Shatin, Hong Kong

  • GSK Investigational Site

    RECRUITING

    Jerusalem, 91031, Israel

  • GSK Investigational Site

    RECRUITING

    Jerusalem, 9112001, Israel

  • GSK Investigational Site

    RECRUITING

    Ramat Gan, 5266202, Israel

  • GSK Investigational Site

    RECRUITING

    Tel Aviv, 64239, Israel

  • GSK Investigational Site

    RECRUITING

    Milan, 20141, Italy

  • GSK Investigational Site

    RECRUITING

    Naples, 80131, Italy

  • GSK Investigational Site

    RECRUITING

    Roma, 00168, Italy

  • GSK Investigational Site

    RECRUITING

    Verona, 37134, Italy

  • GSK Investigational Site

    RECRUITING

    Aichi, 464-8681, Japan

  • GSK Investigational Site

    RECRUITING

    Chiba, 277-8577, Japan

  • GSK Investigational Site

    RECRUITING

    Shizuoka, 411-8777, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 104-0045, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 135-8550, Japan

  • GSK Investigational Site

    RECRUITING

    Panama City, Panama

  • GSK Investigational Site

    RECRUITING

    Panama City, Panama

  • GSK Investigational Site

    RECRUITING

    Gyeonggi-do, 10408, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 03080, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 03722, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 135-710, South Korea

  • GSK Investigational Site

    RECRUITING

    Badajoz, 06080, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08035, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08036, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28034, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28040, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28041, Spain

  • GSK Investigational Site

    RECRUITING

    Málaga, 29010, Spain

  • GSK Investigational Site

    RECRUITING

    Valencia, 46026, Spain

  • GSK Investigational Site

    RECRUITING

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    RECRUITING

    Changhua, 500, Taiwan

  • GSK Investigational Site

    RECRUITING

    Kaohsiung City, 83301, Taiwan

  • GSK Investigational Site

    RECRUITING

    Taichung, 40447, Taiwan

  • GSK Investigational Site

    RECRUITING

    Tainan, 704, Taiwan

  • GSK Investigational Site

    RECRUITING

    Taipei, 10002, Taiwan

  • GSK Investigational Site

    RECRUITING

    Taipei, 11217, Taiwan

  • GSK Investigational Site

    RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, W1G 6AD, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, WC1E 6AG, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

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