Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
- Conditions
- Prostate CancerMetastatic Castration-resistant Prostate CancerCastration Resistant Prostatic Cancer
- Interventions
- Registration Number
- NCT05519449
- Lead Sponsor
- Janux Therapeutics
- 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 in adults with metastatic castration-resistant prostate cancer (mCRPC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 272
- Male ≥18 years of age at the time of signing informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- For Dose Escalation and Backfill: 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
- For Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC or CRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
- For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings
- For Monotherapy Expansion Part d: Have received ≤ 1 anti-androgen therapy and a poly(ADP-ribose) polymerase (PARP) inhibitor for mCRPC and have progressed following treatment with the PARP inhibitor
- For Combination Expansion: Have received ≤ 1 anti-androgen therapy other than darolutamide in the HSPC setting and ≤ 1 taxane in the mCRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
- 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 or radioligand therapy
- Clinically significant cardiovascular disease
- For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting
- For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC
- For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting
- For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation JANX007 IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose. Backfill Expansion JANX007 IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable. Monotherapy Expansion Parts A - D JANX007 IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D). Combination Expansion JANX007 IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose Combination Expansion Darolutamide IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose
- Primary Outcome Measures
Name Time Method Incidence of Dose Limiting Toxicities (DLT) 3 years Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) 3 years
- Secondary Outcome Measures
Name Time Method 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) Number of participants who develop anti-drug antibodies against JANX007 Up to 3 years Duration of Response Up to 3 years Time from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3
Prostate Specific Antigen (PSA) response Up to 3 years Best reduction in PSA level achieved confirmed by a second PSA test ≥21 days later
Radiographic Progression Free Survival (rPFS) Up to 3 years Time from treatment initiation to radiographic evidence of disease progression using RECIST v1.1 and PCWG3
Overall Response Rate Up to 3 years Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3
Overall Survival Up to 3 years Time from treatment initiation until death from any cause
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)
Trial Locations
- Locations (18)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
UCLA Department of Medicine
🇺🇸Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Sarah Cannon Research
🇺🇸Nashville, Tennessee, United States
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Chris O'Brien Lifehouse (COBLH)
🇦🇺Camperdown, New South Wales, Australia
Southern Oncology Clinical Research Unit (SoCRU)
🇦🇺Bedford Park, South Australia, Australia
Linear Clinical Research Ltd.
🇦🇺Nedlands, Western Australia, Australia