Recruiting NCT05519449
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JANX007, Darolutamide.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer. Basic parameters: 18 years — 100 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Overview
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).
Interventions
- Biological JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle. - Drug Darolutamide
Darolutamide is dosed via oral tablets
Primary outcome measures
- Incidence of Dose Limiting Toxicities (DLT) [Time frame: 3 years]
- Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [Time frame: 3 years]
Secondary outcome measures (8)
- 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)]
- 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)]
- Number of participants who develop anti-drug antibodies against JANX007 [Time frame: Up to 3 years]
- Duration of Response [Time frame: Up to 3 years]
- Prostate Specific Antigen (PSA) response [Time frame: Up to 3 years]
- Radiographic Progression Free Survival (rPFS) [Time frame: Up to 3 years]
- Overall Response Rate [Time frame: Up to 3 years]
- Overall Survival [Time frame: Up to 3 years]
Eligibility criteria
Inclusion criteria
- 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.
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 32 centers
- University of Alabama at Birmingham Hospital — Birmingham
- Mayo Clinic — Phoenix
- USC Norris Comprehensive Cancer Center — Los Angeles
- UCLA Department of Medicine — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
- University of California Davis Comprehensive Cancer Center — Sacramento
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
- Yale New Haven Hospital — New Haven
- … and 24 more centers
Australia · 3 centers
- Chris O'Brien Lifehouse (COBLH) — Camperdown
- Southern Oncology Clinical Research Unit (SoCRU) — Bedford Park
- Linear Clinical Research Ltd. — Nedlands
Identifiers
NCT: NCT05519449 · PSMA-007-001 · ENGAGER-PSMA-01