Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK5764227, Ris-Rez, Risvutatug rezetecan (Ris-Rez), HS-20093
Risvutatug rezetecan · 8 trials · 7 indications
rPFS is defined as time from randomization to the first documented radiographic disease progression, per Prostate cancer clinical trials working group 3 (PCWG3) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.
OS is defined as the time from randomization to date of death by any cause.
Number of participants will be assessed
Number of participants will be assessed
Number of participants will be assessed
Number of participants will be assessed
Number of participants will be assessed
cORR is defined as the proportion of participants who have confirmed Complete Response (CR) or Partial Response (PR), assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Confirmed ORR is defined as the proportion of participants who have achieved a confirmed Complete Response (CR) or Partial Response PR as assessed by investigator, according to RECIST 1.1
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)
cORR is defined as the proportion of participants who have confirmed Complete response (CR) or Partial response (PR), assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) criteria or other imaging criteria for defined tumor types.
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 |
|---|---|---|
| Risvutatug rezetecan (Ris-Rez) | EXPERIMENTAL | Participants will receive Risvutatug rezetecan (Ris-Rez). |
| Standard of Care | ACTIVE_COMPARATOR | Participants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone). |
| Topotecan | ACTIVE_COMPARATOR | - |
| Phase 1: Dose escalation | EXPERIMENTAL | - |
| Phase 2: Dose expansion | EXPERIMENTAL | - |
| Cohort 1A (Ris-Rez) | EXPERIMENTAL | - |
| Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)] | EXPERIMENTAL | - |
| Cohort 2 (Ris-Rez) | EXPERIMENTAL | - |
| Metastatic colorectal cancer (mCRC) cohort A1 | EXPERIMENTAL | - |
| Metastatic colorectal cancer (mCRC) cohort A2 | EXPERIMENTAL | - |
| Metastatic castration-resistant prostate cancer (mCRPC) cohort B | EXPERIMENTAL | - |
| CRC-A: Risvutatug Rezetecan (Dose 1) | EXPERIMENTAL | - |
| CRC-A: Risvutatug Rezetecan (Dose 3) | EXPERIMENTAL | - |
| CRC-B: Risvutatug Rezetecan (Dose 6) | EXPERIMENTAL | - |
| CRC-B: Risvutatug Rezetecan (Dose 7) | EXPERIMENTAL | - |
| PDAC-A: Risvutatug Rezetecan (Dose 1/Dose 2 and/or Dose 4/Dose 5) | EXPERIMENTAL | - |
| PDAC-B: Risvutatug Rezetecan (Dose 4/Dose 5 and/or Dose 1/Dose 2) | 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 | 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 (Ris-Rez) | BIOLOGICAL | Risvutatug rezetecan (Ris-Rez) will be administered. |
| Enzalutamide | DRUG | Enzalutamide will be administered. |
| Abiraterone | DRUG | Abiraterone will be administered. |
| Prednisone | DRUG | Prednisone will be administered along with Abiraterone. |
| Prednisolone | DRUG | Prednisolone will be administered along with Abiraterone. |
| Topotecan | DRUG | Topotecan will be administered |
| Risvutatug rezetecan | BIOLOGICAL | Risvutatug rezetecan will be administered |
| Ivonescimab | BIOLOGICAL | Ivonescimab will be administered |
| Ris-Rez | BIOLOGICAL | Ris-Rez will be administered |
| G-CSF | BIOLOGICAL | G-CSF will be administered |
| GSK5764227 | DRUG | Participants will receive GSK5764227. |
| Bevacizumab | DRUG | Participants will receive bevacizumab. |
| Fluorouracil | DRUG | Participants will receive fluorouracil. |
| leucovorin | DRUG | Participants will receive leucovorin. |
| Cisplatin | DRUG | Cisplatin will be administered |
| Carboplatin | DRUG | Carboplatin will be administered |
| Atezolizumab | BIOLOGICAL | Atezolizumab will be administered |
| Pembrolizumab | BIOLOGICAL | Pembrolizumab will be administered |
| Durvalumab | BIOLOGICAL | Durvalumab will be administered |
| Cetuximab | BIOLOGICAL | Cetuximab will be administered |
| Tarlatamab | BIOLOGICAL | Tarlatamab will be administered |
| Dostarlimab | BIOLOGICAL | Dostarlimab will be administered |
Inclusion Criteria: * Participants ≥18 years of age * Has histologically or cytologically confirmed adenocarcinoma of the prostate. * Has an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1, with no deterioration in the 2 weeks before randomization. * Has a life expectancy of at least 4 month...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | Luspatercept, Fedratinib, BMS-986158 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, ABBV-744, IMGN632 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Incyte Corporation | INCY | 8 | PHASE2 | Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Momelotinib |
| Eli Lilly and Company | LLY | 2 | PHASE1 | LY3410738, LY5830966 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Damora Therapeutics, Inc. | DMRA | 2 | PHASE2 | GB2064, DMR-001 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE1 | Revumenib |
Risvutatug rezetecan is an investigational antibody-drug conjugate (ADC) being developed by GSK plc for the treatment of cancer. It is being studied across multiple tumor types, including prostate cancer, lung cancer, sarcoma, and other advanced solid tumors. It is not yet approved and remains in clinical development.
Risvutatug rezetecan is being studied for several cancer indications, including metastatic castration-resistant prostate cancer (mCRPC), lung neoplasms, sarcoma, glioblastoma, gastrointestinal neoplasms, and other advanced solid tumors. It is an investigational therapy and has not been approved for any indication.
Risvutatug rezetecan is developed by GSK plc, which trades under the ticker GSK. GSK is running the clinical development program, which includes studies in prostate cancer, sarcoma, lung cancer, and other advanced solid tumors.
Risvutatug rezetecan is in Phase 1 clinical development, with a Phase 3 trial also underway in metastatic castration-resistant prostate cancer. It is an investigational drug and has not received FDA approval. The program includes both Phase 1 and Phase 3 studies across multiple cancer types.
Risvutatug rezetecan is being evaluated in several recruiting trials: NCT07802704 (Phase 3, mCRPC), NCT07602855 (Phase 1, with ivonescimab in advanced solid tumors), NCT07602777 (Phase 1, advanced sarcomas), and NCT07277270 (Phase 1, with standard of care or other agents in advanced solid tumors). All are currently recruiting.
Yes, risvutatug rezetecan is also known as GSK5764227 and Ris-Rez. These names refer to the same investigational antibody-drug conjugate developed by GSK plc. The alternative designations appear in trial listings and company communications for the same compound.