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New hope for tough prostate cancer? early trial begins

NCT ID NCT05519449

Disease control Sponsor: Janux Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug called JANX007 in men with advanced prostate cancer that has spread and stopped responding to standard treatments. The main goal is to check safety and find the right dose. About 272 men will take part across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JANX007 (an experimental biologic drug given by IV)
What this could lead to
If it works, this could point toward a new treatment option for advanced prostate cancer that has stopped responding to standard therapies.
What could go wrong
This is a very early Phase 1 trial focused on safety, not proof of effectiveness. It is small and may not lead to a working treatment. Side effects are unknown.
Why investors are watching

Janux Therapeutics is running a Phase 1 trial of JANX007, a first-in-human drug for men with metastatic castration-resistant prostate cancer. For a small company, this early-stage readout matters because it is the first test of whether the drug is safe and shows any sign of working. A clear signal could define the company's value, while a weak result could leave it without a lead program.

If it works: If JANX007 shows acceptable safety and hints of tumor control, Janux could advance the drug to later trials and attract partnership interest. That would validate its platform and give the company a path forward.

If it fails: Phase 1 trials often fail to show enough benefit or reveal safety problems, and JANX007 is no exception. A poor result or delay could set Janux back significantly, since the company's prospects rest heavily on this single drug.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 272 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Castration-resistant prostatic cancer Metastatic castration-resistant prostate cancer Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chris O'Brien Lifehouse (COBLH)

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Froedtert Hospital and the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Linear Clinical Research Ltd.

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Mary Crowley Cancer Research

    RECRUITING

    Dallas, Texas, 75230, United States

  • Mayo Clinic

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • NYU Langone Health Long Island

    RECRUITING

    Mineola, New York, 11501, United States

  • Northwell Health R.J. Zuckerberg Cancer Hospital

    RECRUITING

    Lake Success, New York, 11042, United States

  • Penn State Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Sarah Cannon Research

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Southern Oncology Clinical Research Unit (SoCRU)

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43221, United States

  • Thomas Jefferson University Honickman Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA Department of Medicine

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94158, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Alabama at Birmingham Hospital

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Maryland Greenebaum Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Minnesota Medical Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Wisconsin Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10065, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06510, United States

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