Prostate Cancer Clinical Trial

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

Summary

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 adult subjects with metastatic castration-resistant prostate cancer (mCRPC).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT05519449

Recruitment Status:

Recruiting

Sponsor:

Janux Therapeutics

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There are 2 Locations for this study

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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94158, United States
Sarah Cannon Research
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT05519449

Recruitment Status:

Recruiting

Sponsor:


Janux Therapeutics

How clear is this clinincal trial information?

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