Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Conditions

• Castration Resistant Prostatic Cancer
• Metastatic Castration-resistant Prostate Cancer
• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• JANX007 — BIOLOGICAL
  JANX007 is dosed via IV in a 21- or 28-day cycle.
• Darolutamide — DRUG
  Darolutamide is dosed via oral tablets

Study Details

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 JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Key Dates

Start date

Sep 15, 2022

Status verified

Jul 2025

Primary completion

Jul 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

272 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation
  IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.
• Experimental: Backfill Expansion
  IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.
• Experimental: Monotherapy Expansion Parts A - D
  IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).
• Experimental: Combination Expansion
  IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLT) [ Time Frame: 3 years ]

Central Contacts

• Janux Therapeutics
  858-206-8471
  [email protected]

Locations (32)

Find similar trials in Birmingham, AL

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