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

Janux Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Castration Resistant Prostatic Cancer; Metastatic Castration-resistant Prostate Cancer; Prostate Cancer

Treatments: Biological: JANX007

Study type: Interventional

Funder types: Industry

Identifiers

NCT05519449

PSMA-007-001

ENGAGER-PSMA-01 (Other Identifier)

Details and patient eligibility

About

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 administered as a single agent in adults with metastatic castration-resistant prostate cancer (mCRPC).

Enrollment: 105 estimated patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male ≥18 years of age at the time of signing informed consent
• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible
• Adequate organ function

Exclusion criteria

• Prior solid organ transplant
• Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies
• Clinically significant cardiovascular disease
• Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
• Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Dose Escalation

Experimental group

Description:

IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.

Treatment:

Biological: JANX007

Backfill Expansion

Experimental group

Description:

IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.

Treatment:

Biological: JANX007

Expansion

Experimental group

Description:

IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).

Treatment:

Biological: JANX007