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

Sponsored by Janux Therapeutics

About this trial

Last updated 2 years ago

Study ID

PSMA-007-001

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 100 Years
Male
Male

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 months ago

What is this trial 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).

What are the participation requirements?

Yes

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

No

Exclusion Criteria

- Prior solid organ transplant

- Prior treatment with PSMA-targeted CAR-T cell therapy

- 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

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting