Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Risvutatug Rezetecan · 2 trials · 3 indications
Confirmed ORR is defined as the proportion of participants who have achieved best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by investigator, according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
The total, cleaved, and unbound GSK5757810 payload concentration in Gd enhancing and Gd non-enhancing tumor tissue collected during Phase 0 surgery from participants with rGBM, and Gd enhancing tumor tissue collected during Phase 0 surgery from participants with brain metastases, will be determined.
Incidence of the following will be summarized: AEs, SAEs, and AEs of Special Interest (AESIs); treatment discontinuations, dose interruptions, and dose reductions due to AEs; changes in vital signs, body weight, laboratory tests, ECG, and ECOG performance status
| Arm | Type | Description |
|---|---|---|
| CRC-A: Risvutatug Rezetecan (Dose 1) | EXPERIMENTAL | - |
| CRC-A: Risvutatug Rezetecan (Dose 2) | EXPERIMENTAL | - |
| CRC-B: Risvutatug Rezetecan (Dose 3) | EXPERIMENTAL | - |
| CRC-B: Risvutatug Rezetecan (Dose 4) | EXPERIMENTAL | - |
| CRC-C: Risvutatug Rezetecan (Dose 3) + Drug 1 | EXPERIMENTAL | - |
| CRC-D: Risvutatug Rezetecan (Dose 3) + Drug 1 + Drug 2 / Drug 3 | EXPERIMENTAL | - |
| CRC-E: Risvutatug Rezetecan (Dose 3) + Drug 4 | EXPERIMENTAL | - |
| CRC-E: Risvutatug Rezetecan (Dose 3) + Drug 4 + Drug 1 | EXPERIMENTAL | - |
| PDAC: Risvutatug Rezetecan (Dose 1) | EXPERIMENTAL | - |
| rGBM and Brain Mets | EXPERIMENTAL | Group A will include participants with recurrent WHO Grade 4 glioma (rGBM) and group B will include participants with brain metastases (brain mets) |
| Name | Type | Description |
|---|---|---|
| Risvutatug Rezetecan | BIOLOGICAL | Risvutatug Rezetecan will be administered |
| Drug 1 | DRUG | Drug 1 will be administered |
| Drug 2 | DRUG | Drug 2 will be administered |
| Drug 3 | DRUG | Drug 3 will be administered |
| Drug 4 | DRUG | Drug 4 will be administered |
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the informed consent form (ICF). CRC Cohor...
Risvutatug Rezetecan is an investigational monoclonal antibody being studied for gastrointestinal neoplasms and glioblastoma (GBM). It is in Phase 1 clinical development for these oncology indications, including advanced gastrointestinal cancers that cannot be surgically removed and recurrent grade 4 glioma.
Risvutatug Rezetecan targets B7-H3, a protein expressed on tumor cells. It is designed as a B7-H3-targeted antibody-drug conjugate (ADC) that delivers a cytotoxic payload to cancer cells expressing this target.
Risvutatug Rezetecan is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK.
Risvutatug Rezetecan is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is currently being evaluated in early-stage clinical trials for gastrointestinal cancers and glioblastoma.
Risvutatug Rezetecan is being studied in two recruiting trials. NCT06885034 is a Phase 1 study of GSK5764227 alone or with other treatments in advanced gastrointestinal cancers, enrolling 451 participants across multiple countries. NCT07268053 is a Phase 0/1 trial in recurrent grade 4 glioma and brain metastases, enrolling 15 participants in the United States.
Yes, Risvutatug Rezetecan is also known as GSK5764227. Clinical trial records use the GSK5764227 name to refer to this B7-H3-targeted antibody-drug conjugate.