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

About

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

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

Male

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

100 Years

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

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