Approval Probability
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Adjusted LOA
ML Risk
Also known as Mo-Rez, Mocertatug rezetecan (Mo-Rez)
Mocertatug rezetecan · 7 trials · 5 indications
PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first
PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first
PFS is defined as the time from the date of randomization to the date of first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first.
OS is defined as the time from the date of randomization to the date of death due to any cause
ORR is defined as the percentage of participants with best overall confirmed response of either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR)
ORR is defined as the percentage of participants with a best overall confirmed (BOR) of Partial Response (PR) or better per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
| Arm | Type | Description |
|---|---|---|
| Mocertatug rezetecan +/- Bevacizumab | EXPERIMENTAL | - |
| Active Observation +/- Bevacizumab | ACTIVE_COMPARATOR | - |
| Mocertatug rezetecan plus physician's choice of immunotherapy (dostarlimab or pembrolizumab) | EXPERIMENTAL | Participants will receive Mocertatug rezetecan along with physician's choice of immunotherapy (Dostarlimab or Pembrolizumab) |
| Physician's choice of immunotherapy (dostarlimab or pembrolizumab) | ACTIVE_COMPARATOR | Participants will receive physician's choice of immunotherapy (Dostarlimab or Pembrolizumab alone) |
| Mocertatug rezetecan (Mo-Rez) + Bevacizumab | EXPERIMENTAL | Participants will receive Mo-Rez + bevacizumab. |
| Platinum doublet + Bevacizumab | ACTIVE_COMPARATOR | Participants will receive platinum doublet chemotherapy (carboplatin with paclitaxel, gemcitabine, or pegylated liposomal doxorubicin \[PLD\]) and bevacizumab, followed by bevacizumab maintenance therapy. |
| Mocertatug rezetecan | EXPERIMENTAL | Participants will receive Mocertatug rezetecan |
| Standard of care | ACTIVE_COMPARATOR | Participants will receive standard of care chemotherapy (Paclitaxel or Pembrolizumab + paclitaxel ± bevacizumab or PLD or Topotecan or Gemcitabine) as per investigator's choice |
| Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer | EXPERIMENTAL | - |
| Module 2 (Mo-Rez +/-Bevacizumab) Ovarian Cancer | EXPERIMENTAL | - |
| Part 1: Dose Escalation | EXPERIMENTAL | Participants with advanced solid tumors who are refractory or intolerant to established standard therapies |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC) |
| Name | Type | Description |
|---|---|---|
| Mocertatug rezetecan | DRUG | Mocertatug rezetecan will be administered |
| Bevacizumab | DRUG | Bevacizumab will be administered |
| Dostarlimab | DRUG | Dostarlimab will be administered |
| Pembrolizumab | DRUG | Pembrolizumab will be administered |
| Mocertatug rezetecan (Mo-Rez) | DRUG | Mocertatug rezetecan will be administered |
| Carboplatin | DRUG | Carboplatin will be administered |
| Paclitaxel | DRUG | Paclitaxel will be administered |
| Gemcitabine | DRUG | Gemcitabine will be administered |
| Pegylated liposomal doxorubicin (PLD) | DRUG | PLD will be administered |
| Topotecan | DRUG | Topotecan will be administered |
| Doxorubicin | DRUG | Doxorubicin will be administered |
| Mo-Rez | DRUG | Mo-Rez will be administered intravenously (IV). |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed Consent Form (ICF). * Has new...
Mocertatug rezetecan is an investigational antibody-drug conjugate being studied in oncology for gynecological cancers. Its clinical program covers ovarian neoplasms and endometrial cancer, including first-line maintenance treatment of non-homologous recombination deficient ovarian cancer, platinum-sensitive ovarian cancer, and endometrial cancer after platinum-based chemotherapy and immunotherapy.
Mocertatug rezetecan is being developed by GSK plc, which trades under the ticker GSK. GSK is running the clinical program for the asset across ovarian and endometrial cancer indications.
Mocertatug rezetecan is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Four Phase 3 studies are listed in the program, three of which are currently recruiting participants, with a combined planned enrollment of about 1,860 patients.
The Phase 3 program includes BEHOLD-Ovarian03 (NCT07694427) in first-line maintenance of non-HRd ovarian cancer, BEHOLD-Ovarian02 (NCT07684612) in platinum-sensitive ovarian cancer, BEHOLD-Endometrial02 (NCT07684599) in MMRp endometrial cancer maintenance, and BEHOLD-Endometrial01 (NCT07286331) in endometrial cancer after platinum-based chemotherapy and immunotherapy.
Yes, Mo-Rez is an alternative name for mocertatug rezetecan. The two names refer to the same GSK antibody-drug conjugate, so trial records and publications using either name describe the same investigational agent.
Mocertatug rezetecan is being studied in gynecological and solid tumor settings, specifically ovarian neoplasms and endometrial cancer. The trials enroll female participants aged 18 years and older, and the studies use active-controlled designs comparing the agent against platinum doublet chemotherapy with bevacizumab or against chemotherapy.