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

J

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)

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

Trial contacts and locations

11

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Central trial contact

Janux Therapeutics

Data sourced from clinicaltrials.gov

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