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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05519449
Other study ID # PSMA-007-001
Secondary ID ENGAGER-PSMA-01
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 15, 2022
Est. completion date March 2025

Study information

Verified date March 2023
Source Janux Therapeutics
Contact Janux Therapeutics
Phone 858-751-4493
Email psma-007-001_ct.gov@januxrx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 105
Est. completion date March 2025
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.

Locations

Country Name City State
Australia Southern Oncology Clinical Research Unit (SoCRU) Bedford Park South Australia
Australia Chris O'Brien Lifehouse (COBLH) Camperdown New South Wales
Australia Linear Clinical Research Ltd. Nedlands Western Australia
United States Mary Crowley Cancer Research Dallas Texas
United States UCLA Department of Medicine - Hematology/Oncology Los Angeles California
United States Sarah Cannon Research Nashville Tennessee
United States Yale New Haven Hospital New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center New York New York
United States Oregon Health and Science University Portland Oregon
United States Washington University School of Medicine Saint Louis Missouri
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Janux Therapeutics

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Dose Limiting Toxicities (DLT) 3 years
Primary Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) 3 years
Secondary Area under the concentration time curve to infinity of JANX007 (AUC0-inf) Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years)
Secondary Maximum observed concentration of JANX007 (Cmax) Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years)
Secondary Number of participants who develop anti-drug antibodies against JANX007 Up to 3 years
Secondary Duration of Response Time from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3 Up to 3 years
Secondary Prostate Specific Antigen (PSA) response Best reduction in PSA level achieved Up to 3 years
Secondary Radiographic Progression Free Survival (rPFS) Time from treatment initiation to radiographic evidence of disease progression using RECIST v1.1 and PCWG3 Up to 3 years
Secondary Overall Response Rate Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3 Up to 3 years
Secondary Overall Survival Time from treatment initiation until death from any cause Up to 3 years
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