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JANX007 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose. |
| Backfill Expansion | EXPERIMENTAL | IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable. |
| Monotherapy Expansion Parts A - D | EXPERIMENTAL | IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D). |
| Combination Expansion | EXPERIMENTAL | IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose |
| Name | Type | Description |
|---|---|---|
| JANX007 | BIOLOGICAL | JANX007 is dosed via IV in a 21- or 28-day cycle. |
| Darolutamide | DRUG | Darolutamide is dosed via oral tablets |
Inclusion Criteria: * Male ≥18 years of age at the time of signing informed consent * Histologically or cytologically confirmed adenocarcinoma of the prostate * For Dose Escalation and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane cont...
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JANX007 is an investigational monoclonal antibody being studied for the treatment of prostate cancer, specifically metastatic castration-resistant prostate cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
JANX007 targets PSMA, or prostate-specific membrane antigen, a protein commonly expressed on prostate cancer cells. By binding to PSMA, the antibody is designed to direct an immune response against PSMA-expressing tumor cells.
JANX007 is being developed by Janux Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol JANX. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
JANX007 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is actively recruiting participants.
JANX007 is being evaluated in a Phase 1 clinical trial with the identifier NCT05519449, titled 'Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)'. The trial is recruiting in the United States and Australia, with an enrollment target of 272 participants.