Recruiting
Phase 1

GSK5764227

Sponsor:

GlaxoSmithKline

Code:

NCT06551142

Conditions

Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ris-Rez

Cisplatin

Carboplatin

Atezolizumab

Pembrolizumab

Study Details

Brief summary:

The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of Risvutatug rezetecan (Ris-Rez), also known as GSK5764227. The study will also see how the levels of Ris-Rez will change over time at different dose amounts when administered alone and in combination with other medicines like carboplatin, cisplatin, atezolizumab, pembrolizumab, durvalumab, bevacizumab, cetuximab, tarlatamab, dostarlimab

Conditions

Neoplasms

Study ID

NCT06551142

Start date

Sep 30, 2024

Status verified date

May, 2026

Completion date

Jun 8, 2029

Anticipated

Primary completion date

Oct 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

845 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a- Dose escalation- Monotherapy

experimental: Phase 1a- Dose escalation- Combination therapy

experimental: Phase 1b- Dose optimisation- Monotherapy

experimental: Phase 1b- Dose optimisation- Combination therapy

experimental: Phase 1b- Dose expansion- Monotherapy

experimental: Phase 1b- Dose expansion- Combination therapy

Interventions

Ris-Rez

Ris-Rez will be administered

Cisplatin

Cisplatin will be administered

Carboplatin

Carboplatin will be administered

Atezolizumab

Atezolizumab will be administered

Pembrolizumab

Pembrolizumab will be administered

Durvalumab

Durvalumab will be administered

Cetuximab

Cetuximab will be administered

Bevacizumab

Bevacizumab will be administered

Tarlatamab

Tarlatamab will be administered

Dostarlimab

Dostarlimab will be administered

Primary outcome measure

  • Phase 1a: Number of participants with Adverse Events (AEs) [ Time Frame: Up to approximately 28 months ]
  • Phase 1a: Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 21 days ]
  • Phase 1a: Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity [ Time Frame: Up to approximately 30 months ]
  • Phase 1a: Number of participants with AEs leading to dose modifications [ Time Frame: Up to approximately 28 months ]
  • Phase 1a: Number of participants with changes in vital signs, body weight, laboratory tests, electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Up to approximately 28 months ]
  • Phase 1b: Confirmed Objective Response Rate (cORR) [ Time Frame: Up to approximately 27 months ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Stanford, California, United States, 94063

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Christopher Chen

GSK Investigational Site

Recruiting

Denver, Colorado, United States, 80218

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Gerald Falchook

GSK Investigational Site

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Patricia LoRusso

GSK Investigational Site

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sunil Babu

GSK Investigational Site

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Leon Pappas

GSK Investigational Site

Recruiting

Detroit, Michigan, United States, 48201

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Wasif Saif

GSK Investigational Site

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sanjay Goel

GSK Investigational Site

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Neal Shore

GSK Investigational Site

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Benjamin Garmezy

GSK Investigational Site

Recruiting

Austin, Texas, United States, 78705

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Vivian Jean Mikao Cline

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75230

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Reva Schneider

GSK Investigational Site

Recruiting

San Antonio, Texas, United States, 78229

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

David Sommerhalder

GSK Investigational Site

Recruiting

Tyler, Texas, United States, 75702

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Donald Richards

GSK Investigational Site

Recruiting

West Valley City, Utah, United States, 84119

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

William McKean

GSK Investigational Site

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jedrzej Wykretowicz

GSK Investigational Site

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Courtney Coschi

GSK Investigational Site

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

John Hilton

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 1X6

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Albiruni Ryan Ryan Abdul Abdul Razak

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ramy Saleh

GSK Investigational Site

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Michel Pavic

More Information

Sponsor

GlaxoSmithKline

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Solid Tumors
  • GSK5764227
  • Neoplasms
  • EMBOLD PanTumor-101
  • Risvutatug rezetecan
  • Ris-Rez

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-05-22.