Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Conditions
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Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer

Intervention / Treatment
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* Biological: JANX007


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation<br>Weekly dosing during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose. | Biological: JANX007<br>* JANX007 is dosed via IV weekly in a 21-day cycle<br>|
| Experimental: Backfill Expansion<br>Weekly dosing during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable. | Biological: JANX007<br>* JANX007 is dosed via IV weekly in a 21-day cycle<br>|
| Experimental: Expansion<br>Weekly dosing during each 21-day cycle. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D). | Biological: JANX007<br>* JANX007 is dosed via IV weekly in a 21-day cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Dose Limiting Toxicities (DLT) |  | 3 years | 
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | Time from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3 | Up to 3 years | 
| Prostate Specific Antigen (PSA) response | Best reduction in PSA level achieved | Up to 3 years | 
| Radiographic Progression Free Survival (rPFS) | Time from treatment initiation to radiographic evidence of disease progression using RECIST v1.1 and PCWG3 | Up to 3 years | 
| Overall Response Rate | Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3 | Up to 3 years | 
| Overall Survival | Time from treatment initiation until death from any cause | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Castration-resistant prostate cancer