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RecruitingInterventionalPhase 1

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

NCT ID: NCT05519449Sponsor: Janux TherapeuticsLast updated: 2026-01-20

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).

Arms & interventions

  • BiologicalJANX007

    JANX007 is dosed via IV in a 21- or 28-day cycle.

  • DrugDarolutamide

    Darolutamide is dosed via oral tablets

Outcome measures

Primary

  • 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

  • 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

Sex: MaleAge: 18 Years to 100 YearsHealthy volunteers: No
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

Study locations (32)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35249

Recruiting

Mayo Clinic

Phoenix, Arizona, 85054

Recruiting

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting

UCLA Department of Medicine

Los Angeles, California, 90095

Recruiting

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

Recruiting

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

Recruiting

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158

Recruiting

Yale New Haven Hospital

New Haven, Connecticut, 06510

Recruiting

Mayo Clinic

Jacksonville, Florida, 32224

Recruiting

University of Chicago Medical Center

Chicago, Illinois, 60637

Recruiting

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Active Not Recruiting

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455

Recruiting

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting

Northwell Health R.J. Zuckerberg Cancer Hospital

Lake Success, New York, 11042

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

Weill Cornell Medicine

New York, New York, 10065

Recruiting

Montefiore Medical Center

The Bronx, New York, 10461

Recruiting

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267

Recruiting

Oregon Health and Science University

Portland, Oregon, 97239

Active Not Recruiting

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

Recruiting

Thomas Jefferson University Honickman Center

Philadelphia, Pennsylvania, 19107

Recruiting

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting

Rhode Island Hospital

Providence, Rhode Island, 02903

Recruiting

Medical University of South Carolina

Charleston, South Carolina, 29425

Recruiting

Sarah Cannon Research

Nashville, Tennessee, 37203

Recruiting

Mary Crowley Cancer Research

Dallas, Texas, 75230

Recruiting

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Recruiting

Houston Methodist Hospital

Houston, Texas, 77030

Recruiting

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792

Recruiting

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting