Trial Title:
Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
NCT ID:
NCT05519449
Condition:
Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Castration Resistant Prostatic Cancer
Conditions: Official terms:
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Conditions: Keywords:
Prostate Cancer
Castration-resistant prostate cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
JANX007
Description:
JANX007 is dosed via IV in a 21- or 28-day cycle.
Arm group label:
Backfill Expansion
Arm group label:
Dose Escalation
Arm group label:
Expansion
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).
Criteria for eligibility:
Criteria:
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
Gender:
Male
Gender based:
Yes
Gender description:
Gender Identity
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA Department of Medicine
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Davis Comprehensive Cancer Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Facility:
Name:
UCSF Helen Diller Family Comprehensive Cancer Center
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Email:
HDFCCC.CIP@ucsf.edu
Facility:
Name:
Yale New Haven Hospital
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago Medical Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Weill Cornell Medicine
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Facility:
Name:
Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston Methodist Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Chris O'Brien Lifehouse (COBLH)
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Southern Oncology Clinical Research Unit (SoCRU)
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Facility:
Name:
Linear Clinical Research Ltd.
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Start date:
September 15, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
Janux Therapeutics
Agency class:
Industry
Source:
Janux Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519449
