Approval Probability
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vudalimab · 2 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| vudalimab | EXPERIMENTAL | - |
| Cohort A - AVPCa | EXPERIMENTAL | - |
| Cohort B - HRD/CDK12 PARP - Progressors | EXPERIMENTAL | - |
| Cohort C - HRD/CDK12 PARP Naïve | EXPERIMENTAL | - |
| Cohort D - MSI-H, MMRD or TMB-H | EXPERIMENTAL | - |
| Cohort E - No Targetable Mutations | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| vudalimab | BIOLOGICAL | Monoclonal bispecific antibody |
| vudalimab + carboplatin + cabazitaxel | COMBINATION_PRODUCT | Vudalimab IV, carboplatin IV, cabazitaxel IV |
| vudalimab + olaparib | COMBINATION_PRODUCT | Vudalimab IV, olaparib oral |
| vudalimab monotherapy | BIOLOGICAL | Vudalimab IV |
| vudalimab + docetaxel | COMBINATION_PRODUCT | Vudalimab IV, docetaxel IV |
| vudalimab + cabazitaxel or docetaxel | COMBINATION_PRODUCT | Vudalimab IV, cabazitaxel or docetaxel IV |
Inclusion Criteria: * Able to provide written informed consent * Adult (age ≥ 18 years) * Cancer must have progressed after treatment with standard of care therapy approved for the treatment of that indication * Histologically confirmed diagnosis of one of the following tumor types, along with clin...
Vudalimab is an investigational monoclonal antibody being studied in oncology for metastatic castration-resistant prostate cancer and ovarian cancer, including clear cell carcinoma. It is also being evaluated in other advanced gynecologic and genitourinary malignancies such as endometrial cancer and cervical carcinoma. It is not approved for any indication.
Vudalimab targets PD-1 and CTLA-4, two immune checkpoint proteins. By binding both targets, it is designed to enhance T-cell activation against tumor cells. This dual-targeting approach is intended to improve anti-tumor immune responses compared with single-checkpoint blockade.
Vudalimab is being developed by Xencor, Inc., which trades on the Nasdaq under the ticker XNCR. Xencor is a clinical-stage biopharmaceutical company focused on engineered antibodies for cancer and autoimmune diseases.
Vudalimab is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 2 program includes studies in metastatic castration-resistant prostate cancer and selected advanced gynecologic and genitourinary malignancies.
Vudalimab has been studied in two Phase 2 trials. NCT05032040 is an active, not recruiting study in advanced gynecologic and genitourinary malignancies, including ovarian, endometrial, cervical, and prostate cancers, with 170 patients enrolled. NCT05005728 is a completed Phase 2 trial in metastatic castration-resistant prostate cancer that enrolled 72 patients.