Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | JANX014 will be administered at increasing dose levels per cohort to determine the maximum tolerated dose. |
|
| Dose Expansion | Experimental | Participants will be dosed at levels previously declared tolerable. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JANX014 | Biological | JANX014 will be administered via IV dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) | 2 years | |
| Incidence of adverse events (AE) and Serious Adverse Events (SAE) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time 0 to t of JANX014 (AUC0-t) | up to 2 years | |
| Maximum observed concentration of JANX014 (Cmax) | up to 2 years | |
| Number of participants who develop anti-drug antibodies against JANX014 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janux Therapeutics, MD | Contact | +1 858-206-8471 | PRCA-014-001_ct.gov@januxrx.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Nashville | Tennessee | 37203 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 2 years |
| Prostate Specific Antigen (PSA) response | up to 2 years |
| Overall Response Rate | up to 2 years |
| Duration of Response | up to 2 years |
| Radiographic Progression Free Survival (rPFS) | up to 2 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |