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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05519449




Registration number
NCT05519449
Ethics application status
Date submitted
25/08/2022
Date registered
29/08/2022
Date last updated
4/03/2024

Titles & IDs
Public title
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Scientific title
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
ENGAGER-PSMA-01
Secondary ID [2] 0 0
PSMA-007-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Metastatic Castration-resistant Prostate Cancer 0 0
Castration Resistant Prostatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - JANX007

Experimental: Dose Escalation - IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.

Experimental: Backfill Expansion - IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.

Experimental: Expansion - IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).


Other interventions: JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Dose Limiting Toxicities (DLT)
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Timepoint [2] 0 0
3 years
Secondary outcome [1] 0 0
Area under the concentration time curve to infinity of JANX007 (AUC0-inf)
Timepoint [1] 0 0
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 outcome [2] 0 0
Maximum observed concentration of JANX007 (Cmax)
Timepoint [2] 0 0
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 outcome [3] 0 0
Number of participants who develop anti-drug antibodies against JANX007
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Duration of Response
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Prostate Specific Antigen (PSA) response
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Radiographic Progression Free Survival (rPFS)
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Overall Response Rate
Timepoint [7] 0 0
Up to 3 years
Secondary outcome [8] 0 0
Overall Survival
Timepoint [8] 0 0
Up to 3 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse (COBLH) - Camperdown
Recruitment hospital [2] 0 0
Southern Oncology Clinical Research Unit (SoCRU) - Bedford Park
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd. - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janux Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05519449
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janux Therapeutics, MD
Address 0 0
Janux Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Janux Therapeutics
Address 0 0
Country 0 0
Phone 0 0
858-751-4493
Fax 0 0
Email 0 0
psma-007-001_ct.gov@januxrx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05519449