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

Phase 1

Recruiting

• Conditions: Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; Castration Resistant Prostatic Cancer
• Interventions: Biological: JANX007

• 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 administered as a single agent in adults with metastatic castration-resistant prostate cancer (mCRPC).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-29
• Study Start: 2022-09-15
• Status Verified: 2023-03
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04
• Primary Completion: 2024-08
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 105

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Backfill Expansion	JANX007	IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.
Dose Escalation	JANX007	IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.
Expansion	JANX007	IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).

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
Prostate Specific Antigen (PSA) response	Up to 3 years	Best reduction in PSA level achieved
Number of participants who develop anti-drug antibodies against JANX007	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)
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)
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
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 Survival	Up to 3 years	Time from treatment initiation until death from any cause
Overall Response Rate	Up to 3 years	Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3

Trial Locations

Locations (16)

UCLA Department of Medicine; 🇺🇸 Los Angeles, California, United States

University of California Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Sarah Cannon Research; 🇺🇸 Nashville, Tennessee, United States

Mary Crowley Cancer Research; 🇺🇸 Dallas, 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