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

Prostate Cancer Clinical Trial

Official title:

A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer

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
• 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
• 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

Related Conditions & MeSH terms

• Castration Resistant Prostatic Cancer
• Metastatic Castration-resistant Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

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