Back to resultsStudy of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Primary Purpose
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JANX007
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Castration-resistant prostate cancer
Eligibility Criteria
Inclusion Criteria:
- Male subjects ≥18 years of age at the time of signing informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Subjects with mCRPC who progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Subjects who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible
- PSMA expressing tumor
- Adequate organ function
Exclusion Criteria:
- Prior solid organ transplant
- Prior treatment with PSMA-targeted CAR-T cell therapy
- 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
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer CenterRecruiting
- Yale New Haven HospitalRecruiting
- Washington University School of MedicineRecruiting
- Sarah Cannon ResearchRecruiting
- Mary Crowley Cancer ResearchRecruiting
- Chris O'Brien Lifehouse (COBLH)Recruiting
- Southern Oncology Clinical Research Unit (SoCRU)Recruiting
- Linear Clinical Research Ltd.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dose Escalation
Backfill Expansion
Expansion
Arm Description
Weekly dosing during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
Weekly dosing during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
Weekly dosing during each 21-day cycle. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).
Outcomes
Primary Outcome Measures
Incidence of Dose Limiting Toxicities (DLT)
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Secondary Outcome Measures
Area under the concentration time curve to infinity of JANX007 (AUC0-inf)
Maximum observed concentration of JANX007 (Cmax)
Number of participants who develop anti-drug antibodies against JANX007
Duration of Response
Time from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3
Prostate Specific Antigen (PSA) response
Best reduction in PSA level achieved
Radiographic Progression Free Survival (rPFS)
Time from treatment initiation to radiographic evidence of disease progression using RECIST v1.1 and PCWG3
Overall Response Rate
Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3
Overall Survival
Time from treatment initiation until death from any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05519449
Brief Title
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Official Title
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janux Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer
Keywords
Prostate Cancer, Castration-resistant prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
Weekly dosing during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
Arm Title
Backfill Expansion
Arm Type
Experimental
Arm Description
Weekly dosing during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
Arm Title
Expansion
Arm Type
Experimental
Arm Description
Weekly dosing during each 21-day cycle. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).
Intervention Type
Biological
Intervention Name(s)
JANX007
Intervention Description
JANX007 is dosed via IV weekly in a 21-day cycle
Primary Outcome Measure Information:
Title
Incidence of Dose Limiting Toxicities (DLT)
Time Frame
3 years
Title
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Area under the concentration time curve to infinity of JANX007 (AUC0-inf)
Time Frame
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)
Title
Maximum observed concentration of JANX007 (Cmax)
Time Frame
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)
Title
Number of participants who develop anti-drug antibodies against JANX007
Time Frame
Up to 3 years
Title
Duration of Response
Description
Time from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3
Time Frame
Up to 3 years
Title
Prostate Specific Antigen (PSA) response
Description
Best reduction in PSA level achieved
Time Frame
Up to 3 years
Title
Radiographic Progression Free Survival (rPFS)
Description
Time from treatment initiation to radiographic evidence of disease progression using RECIST v1.1 and PCWG3
Time Frame
Up to 3 years
Title
Overall Response Rate
Description
Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3
Time Frame
Up to 3 years
Title
Overall Survival
Description
Time from treatment initiation until death from any cause
Time Frame
Up to 3 years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Gender Identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janux Therapeutics
Phone
858-751-4493
Email
PSMA-007-001@januxrx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janux Therapeutics, MD
Organizational Affiliation
Janux Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
HDFCCC.CIP@ucsf.edu
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
Chris O'Brien Lifehouse (COBLH)
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Southern Oncology Clinical Research Unit (SoCRU)
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Name
Linear Clinical Research Ltd.
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
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