Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Status
RECRUITING
Phase
PHASE1
Age
18 - 100 Years
Enrollments
105Conditions
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic CancerSummary
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).
Locations
13 locations Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Janux Therapeutics
- 858-751-4493
- [email protected]
Study Director
- Janux Therapeutics, MD
Status
- RECRUITING
Central Contacts
- Janux Therapeutics
- 858-751-4493
- [email protected]
Study Director
- Janux Therapeutics, MD
Status
- RECRUITING
Study Director
- Janux Therapeutics, MD
Status
- RECRUITING
Study Director
- Janux Therapeutics, MD
Status
- RECRUITING
Study Director
- Janux Therapeutics, MD
Status
- RECRUITING
Study Director
- Janux Therapeutics, MD
Status
- RECRUITING
Study Director
- Janux Therapeutics, MD
Status
- RECRUITING
Study Director
- Janux Therapeutics, MD
Status
- RECRUITING
Study Director
- Janux Therapeutics, MD
Status
- RECRUITING
Study Director
- Janux Therapeutics, MD
Status
- RECRUITING
Study Director
- Janux Therapeutics, MD
Status
- RECRUITING
Study Director
- Janux Therapeutics, MD
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
Study Plan
Dose Escalation
EXPERIMENTAL
IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.
BIOLOGICAL:
JANX007Description:
JANX007 is dosed via IV in a 21- or 28-day cycle.
Backfill Expansion
EXPERIMENTAL
IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.
BIOLOGICAL:
JANX007Description:
JANX007 is dosed via IV in a 21- or 28-day cycle.
Expansion
EXPERIMENTAL
IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).
BIOLOGICAL:
JANX007Description:
JANX007 is dosed via IV in a 21- or 28-day cycle.
Outcome Measures
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
Prostate Specific Antigen (PSA) response
Radiographic Progression Free Survival (rPFS)
Overall Response Rate
Overall Survival
Timeline
Last Updated
September 23, 2024Start Date
August 29, 2022Today
February 5, 2025Completion Date ( Estimated )
December 1, 2026
Sponsors of this trial
Lead Sponsor
Janux Therapeutics
RECRUITING 
21 - 64 Years