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Prostate CancerPhase 1NCT05519449

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

A Phase 1 study testing JANX007 and Darolutamide in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Janux Therapeutics at 38 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 100 years, men only
What is being tested?
JANX007 and Darolutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
38 sitesin 3 countries
Study dates
15 Sep 2022to Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

38 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Janux Therapeutics contact

858-206-8471

psma-007-001_ct.gov@januxrx.com

38 sites in 3 countries

United States33 sites, 33 recruiting

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

    Recruiting

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35249

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43221

    Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Recruiting

  • Northwell Health R.J. Zuckerberg Cancer Hospital

    Lake Success, New York, 11042

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Recruiting

  • UCLA Department of Medicine

    Los Angeles, California, 90095

    Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

    Recruiting

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • NYU Langone Health Long Island

    Mineola, New York, 11501

    Recruiting

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

    Recruiting

  • Sarah Cannon Research

    Nashville, Tennessee, 37203

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Recruiting

  • Thomas Jefferson University Honickman Center

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Mayo Clinic

    Phoenix, Arizona, 85054

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

    HDFCCC.CIP@ucsf.edu

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10461

    Recruiting

Other trials in United States

Australia3 sites, 3 recruiting

  • Southern Oncology Clinical Research Unit (SoCRU)

    Bedford Park, South Australia, 5042

    Recruiting

  • Chris O'Brien Lifehouse (COBLH)

    Camperdown, New South Wales, 2050

    Recruiting

  • Linear Clinical Research Ltd.

    Nedlands, Western Australia, 6009

    Recruiting

Other trials in Australia

Spain2 sites, 2 recruiting

  • Start Madrid - FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040

    Recruiting

  • START Madrid / Centro Integral Oncologico Clara Campal

    Madrid, 28050

    Recruiting

Other trials in Spain

About this study

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

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).

Being tested
JANX007, Darolutamide
Keywords
Prostate Cancer, Castration-resistant prostate cancer
Medical subject headings
Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JANX007Biological

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

  • DarolutamideDrug

    Darolutamide is dosed via oral tablets

Study groups in NCT05519449
Study groupRoleWhat they receive
Dose EscalationExperimentalIV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.
Receives: Biological: JANX007
Backfill ExpansionExperimentalIV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.
Receives: Biological: JANX007
Monotherapy Expansion Parts A - DExperimentalIV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).
Receives: Biological: JANX007
Combination ExpansionExperimentalIV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose
Receives: Biological: JANX007; Drug: Darolutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limiting Toxicities (DLT)

    Measured: 3 years

  2. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)

    Measured: 3 years

Secondary outcomes (8)

  1. Area under the concentration time curve to infinity of JANX007 (AUC0-inf)

    Measured: 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)

    Measured: 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

    Measured: Up to 3 years

  4. Duration of Response

    Time from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3

    Measured: Up to 3 years

  5. Prostate Specific Antigen (PSA) response

    Best reduction in PSA level achieved confirmed by a second PSA test ≥21 days later

    Measured: Up to 3 years

  6. Radiographic Progression Free Survival (rPFS)

    Time from treatment initiation to radiographic evidence of disease progression using RECIST v1.1 and PCWG3

    Measured: Up to 3 years

  7. Overall Response Rate

    Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3

    Measured: Up to 3 years

  8. Overall Survival

    Time from treatment initiation until death from any cause

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2022
  2. Study start15 Sep 2022
  3. Primary completionJul 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
272 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05519449
Sponsor's protocol ID
PSMA-007-001
Other IDs
ENGAGER-PSMA-01
Status last verified
Oct 2026
First submitted
25 Aug 2022
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JANX007 and Darolutamide in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Janux Therapeutics at 38 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Australia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janux Therapeutics (858-206-8471, psma-007-001_ct.gov@januxrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities (DLT) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05519449.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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