Cancer Clinical Trials
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Learn moreWhat is the purpose of this study?
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 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Eligibility
- Male ≥18 years of age at the time of signing informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- For Dose Escalation and Backfill: 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
- For Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC or CRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
- For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings
- For Monotherapy Expansion Part d: Have received ≤ 1 anti-androgen therapy and a poly(ADP-ribose) polymerase (PARP) inhibitor for mCRPC and have progressed following treatment with the PARP inhibitor
- For Combination Expansion: Have received ≤ 1 anti-androgen therapy other than darolutamide in the HSPC setting and ≤ 1 taxane in the mCRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
- 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 or radioligand therapy
- Clinically significant cardiovascular disease
- For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting
- For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC
- For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting
- For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC
- 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
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
- Disease Type/ConditionProstate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer
- Principal InvestigatorDavid J. Benjamin, MD
- Co-InvestigatorsCarlos R. Becerra, MD, Chelsea Brown, NP, Sharmeen Mahmood, DO, Shannon Hooper, NP, Rafi Ahmed, MD
- Age GroupAdult, Older Adult
- PhaseI
- ClinicalTrials.gov IDNCT05519449
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Lauren Wagner
lauren.wagner@hoag.org
Hoag Family Cancer Institute
Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.
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