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Trial record 2 of 2 for:    janux
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Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

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ClinicalTrials.gov Identifier: NCT05519449
Recruitment Status : Recruiting
First Posted : August 29, 2022
Last Update Posted : March 4, 2024
Sponsor:
Information provided by (Responsible Party):
Janux Therapeutics

Study Description
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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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Castration-resistant Prostate Cancer Castration Resistant Prostatic Cancer Biological: JANX007 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : September 15, 2022
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation
IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.
 Biological: JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
Experimental: Backfill Expansion
IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.
 Biological: JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
Experimental: Expansion
IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).
 Biological: JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities (DLT) [ Time Frame: 3 years ]
  2. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Number of participants who develop anti-drug antibodies against JANX007 [ Time Frame: Up to 3 years ]
  4. Duration of Response [ Time Frame: Up to 3 years ]
    Time from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3

  5. Prostate Specific Antigen (PSA) response [ Time Frame: Up to 3 years ]
    Best reduction in PSA level achieved

  6. Radiographic Progression Free Survival (rPFS) [ Time Frame: Up to 3 years ]
    Time from treatment initiation to radiographic evidence of disease progression using RECIST v1.1 and PCWG3

  7. Overall Response Rate [ Time Frame: Up to 3 years ]
    Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3

  8. Overall Survival [ Time Frame: Up to 3 years ]
    Time from treatment initiation until death from any cause


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gender Identity
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05519449


Contacts
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Contact: Janux Therapeutics 858-751-4493 psma-007-001_ct.gov@januxrx.com

Locations
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United States, California
UCLA Department of Medicine - Hematology/Oncology Recruiting
Los Angeles, California, United States, 90095
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94158
Contact       HDFCCC.CIP@ucsf.edu   
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
Sarah Cannon Research Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Australia, New South Wales
Chris O'Brien Lifehouse (COBLH) Recruiting
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Southern Oncology Clinical Research Unit (SoCRU) Recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Western Australia
Linear Clinical Research Ltd. Recruiting
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Janux Therapeutics
Investigators
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Study Director: Janux Therapeutics, MD Janux Therapeutics
More Information
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Responsible Party: Janux Therapeutics
ClinicalTrials.gov Identifier: NCT05519449    
Other Study ID Numbers: PSMA-007-001
ENGAGER-PSMA-01 ( Other Identifier: Janux Therapeutics., Inc )
First Posted: August 29, 2022    Key Record Dates
Last Update Posted: March 4, 2024
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janux Therapeutics:
Prostate Cancer
Castration-resistant prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases