Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 100 Years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About 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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * 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. 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 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
Study sites (33)
AL
- University of Alabama at Birmingham Hospital · Birmingham, AL 35249More trials in Birmingham
AZ
- Mayo Clinic · Phoenix, AZ 85054More trials in Phoenix
CA
- USC Norris Comprehensive Cancer Center · Los Angeles, CA 90033More trials in Los Angeles
- UCLA Department of Medicine · Los Angeles, CA 90095More trials in Los Angeles
- Hoag Memorial Hospital Presbyterian · Newport Beach, CA 92663More trials in Newport Beach
- University of California Davis Comprehensive Cancer Center · Sacramento, CA 95817More trials in Sacramento
- UCSF Helen Diller Family Comprehensive Cancer Center · San Francisco, CA 94158 · Study contact · HDFCCC.CIP@ucsf.eduMore trials in San Francisco
CT
- Yale New Haven Hospital · New Haven, CT 06510More trials in New Haven
FL
- Mayo Clinic · Jacksonville, FL 32224More trials in Jacksonville
IL
- University of Chicago Medical Center · Chicago, IL 60637More trials in Chicago
MD
- University of Maryland Greenebaum Comprehensive Cancer Center · Baltimore, MD 21201More trials in Baltimore
MN
- University of Minnesota Medical Center · Minneapolis, MN 55455More trials in Minneapolis
- Mayo Clinic · Rochester, MN 55905More trials in Rochester
MO
- Washington University School of Medicine · St Louis, MO 63110More trials in St Louis
NY
- Northwell Health R.J. Zuckerberg Cancer Hospital · Lake Success, NY 11042More trials in Lake Success
- NYU Langone Health Long Island · Mineola, NY 11501More trials in Mineola
- NYU Langone Health · New York, NY 10016More trials in New York
- Memorial Sloan Kettering Cancer Center · New York, NY 10065More trials in New York
- Weill Cornell Medicine · New York, NY 10065More trials in New York
- Montefiore Medical Center · The Bronx, NY 10461More trials in The Bronx
OH
- University of Cincinnati Medical Center · Cincinnati, OH 45267More trials in Cincinnati
- The Ohio State University · Columbus, OH 43221More trials in Columbus
PA
- Penn State Milton S. Hershey Medical Center · Hershey, PA 17033More trials in Hershey
- Thomas Jefferson University Honickman Center · Philadelphia, PA 19107More trials in Philadelphia
- UPMC Hillman Cancer Center · Pittsburgh, PA 15232More trials in Pittsburgh
RI
- Rhode Island Hospital · Providence, RI 02903More trials in Providence
SC
- Medical University of South Carolina · Charleston, SC 29425More trials in Charleston
TN
- Sarah Cannon Research · Nashville, TN 37203More trials in Nashville
TX
- Mary Crowley Cancer Research · Dallas, TX 75230More trials in Dallas
- University of Texas Southwestern Medical Center · Dallas, TX 75390More trials in Dallas
- Houston Methodist Hospital · Houston, TX 77030More trials in Houston
WI
- University of Wisconsin Carbone Cancer Center · Madison, WI 53792More trials in Madison
- Froedtert Hospital and the Medical College of Wisconsin · Milwaukee, WI 53226More trials in Milwaukee