Prostate CancerPhase 1NCT07545811
Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study testing JANX014 in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Janux Therapeutics at 6 sites in United States.
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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration-resistant Prostate Cancer
- What is being tested?
- JANX014
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Apr 2026to Mar 2029
- 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 years and older
- 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: 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 Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC 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 any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy
- Clinically significant cardiovascular disease
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, 29425
- Recruiting
SCRI at Mary Crowley
Dallas, Texas, 75230
- Recruiting
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92037
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
Official title: A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With 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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration-resistant Prostate Cancer
- Being tested
- JANX014
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JANX014Biological
JANX014 will be administered via IV dosing
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | JANX014 will be administered at increasing dose levels per cohort to determine the maximum tolerated dose. Receives: Biological: JANX014 |
| Dose Expansion | Experimental | Participants will be dosed at levels previously declared tolerable. Receives: Biological: JANX014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs)
Measured: 2 years
Incidence of adverse events (AE) and Serious Adverse Events (SAE)
Measured: 2 years
Secondary outcomes (7)
Area under the curve from time 0 to t of JANX014 (AUC0-t)
Measured: up to 2 years
Maximum observed concentration of JANX014 (Cmax)
Measured: up to 2 years
Number of participants who develop anti-drug antibodies against JANX014
Measured: up to 2 years
Prostate Specific Antigen (PSA) response
Measured: up to 2 years
Overall Response Rate
Measured: up to 2 years
Duration of Response
Measured: up to 2 years
Radiographic Progression Free Survival (rPFS)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 Apr 2026
- Primary completionMay 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janux Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545811
- Sponsor's protocol ID
- PRCA-014-001
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With Prostate Cancer
- ClinicalTrials.gov ID
- NCT07545811
- Acronym / sponsor ID
- PRCA-014-001
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration-resistant Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Janux TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Biological: JANX014JANX014 will be administered at increasing dose levels per cohort to determine the maximum tolerated dose. |
| Dose Expansion | Experimental | Biological: JANX014Participants will be dosed at levels previously declared tolerable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male ≥18 years of age at the time of signing informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- For Dose Escalation: 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 Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
Key exclusion criteria (3 listed)
- Prior solid organ transplant
- Prior treatment with any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy
- Clinically significant cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JANX014JANX014 will be administered via IV dosing | Biological | Dose Escalation, Dose Expansion |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: 2 years
Incidence of adverse events (AE) and Serious Adverse Events (SAE)
Time frame: 2 years
7 secondary outcomes
Area under the curve from time 0 to t of JANX014 (AUC0-t)
Time frame: up to 2 years
Maximum observed concentration of JANX014 (Cmax)
Time frame: up to 2 years
Number of participants who develop anti-drug antibodies against JANX014
Time frame: up to 2 years
Prostate Specific Antigen (PSA) response
Time frame: up to 2 years
Overall Response Rate
Time frame: up to 2 years
Duration of Response
Time frame: up to 2 years
Radiographic Progression Free Survival (rPFS)
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JANX014 in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Janux Therapeutics at 6 sites in United States.
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 5 inclusion and 3 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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, MD (+1 858-206-8471, PRCA-014-001_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 (DLTs) (time frame: 2 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?
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 3 Sep 2026.