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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 therapy being developed for prostate cancer, including metastatic castration-resistant prostate cancer. It is a monoclonal antibody that targets PSMA and is being studied in adult male patients with these advanced prostate cancer conditions.
JANX007 targets PSMA, or prostate-specific membrane antigen. It is a monoclonal antibody directed at this target, and it is being developed as an investigational treatment for prostate cancer, including metastatic castration-resistant prostate cancer.
JANX007 is being developed by Janux Therapeutics, Inc., which trades under the ticker JANX. The company is running the clinical development program for this PSMA-targeting monoclonal antibody in prostate cancer.
JANX007 is in Phase 1 clinical development. It is an investigational agent and is not described as approved; its only listed trial is a Phase 1 study that is currently recruiting participants.
JANX007 is being studied in the ENGAGER-PSMA-01 trial, registered as NCT05519449. This Phase 1 study enrolls adults aged 18 years and older with metastatic castration-resistant prostate cancer and other prostate cancer conditions, and it is recruiting in the United States, Australia, and Spain.
The ENGAGER-PSMA-01 trial of JANX007, NCT05519449, has a planned enrollment of 272 participants. It is a controlled Phase 1 study in adult male patients with metastatic castration-resistant prostate cancer and related prostate cancer conditions.