Prostate CancerPhase 1PSMA-013-001NCT07813637
Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC
A Phase 1 study testing JANX013 and JANX007 in people with Prostate Cancer and Castration-Resistant Prostate Cancer (CRPC), run by Janux Therapeutics at 1 site 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 JANX013 in combination with JANX007 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, Castration-Resistant Prostate Cancer (CRPC), Metastatic Prostate Cancer
- What is being tested?
- JANX013 and JANX007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to Jul 2030
- 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 participants ≥ 18 years of age at the time of signing informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- For Dose Escalation:
- Have received at least 1 novel ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, or darolutamide) in any setting and have received at least 1 taxane regimen (in any setting), or who are medically unsuitable or have actively refused treatment with a taxane regimen.
- For Dose Expansion:
- Must be in the first-line or second-line setting for mCRPC or metastatic androgen pathway modulation resistant disease and must have received 1 novel ARPI in any setting.
- Adequate organ function
Who cannot join
- Prior treatment with any chimeric antigen receptor (CAR) T-cell therapy, any approved or investigational TCE, or any T-cell costimulatory agent
- Clinically significant cardiovascular disease
- Prior solid organ transplant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: A Phase 1 Open-Label, Multicenter Study of JANX013 Combined With JANX007 in Participants 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 JANX013 in combination with JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).
- Conditions
- Prostate Cancer, Castration-Resistant Prostate Cancer (CRPC), Metastatic Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer Patients
- Being tested
- JANX013, JANX007
- Keywords
- mCRPC, Metastatic Castration-Resistant Prostate Cancer, PSMA, Prostate-Specific Membrane Antigen, CD3 T cell engager, T cell engager, Bispecific antibody, Immunotherapy, Prostate cancer metastatic
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JANX013Drug
JANX013 will be administered via IV dosing.
JANX007Drug
JANX007 will be administered via IV dosing.
JANX013Drug
JANX013 will be administered via IV dosing
JANX007Drug
JANX007 will be administered via IV dosing
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Participants receive JANX013 in combination with JANX007 administered at increasing dose levels per cohort Receives: Drug: JANX013; Drug: JANX007 |
| Dose Expansion | Experimental | Participants receive JANX013 in combination with JANX007. Participants will be dosed at levels previously declared tolerable. Receives: Drug: JANX013; Drug: JANX007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Measured: 2 years
Incidence of cytokine release syndrome (CRS)
Cytokine release syndrome (CRS) assessed according to ASTCT criteria.
Measured: 2 years
Secondary outcomes (8)
Area under the curve from 0 to t of JANX013 and JANX007
Measured: Up to 2 years
Maximum observed concentration of JANX013 and JANX007
Measured: Up to 2 years
Time to maximum concentration of JANX013 and JANX007
Measured: Up to 2 years
Number of participants who develop anti-drug antibodies (ADAs) against JANX013 and JANX007
Measured: Up to 2 years
Prostate-specific antigen (PSA) response
Measured: Up to 2 years
Radiographic progression-free survival (rPFS)
Measured: Up to 2 years
Duration of response (DOR)
Measured: Up to 2 years
Disease control rate (DCR)
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 posted10 Sep 2026
- Study start10 Sep 2026
- Primary completionJul 2029 (estimated)
- Study completionJul 2030 (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
- Model description
- Participants are assigned to sequential cohorts in a dose-escalation phase followed by dose-expansion cohorts evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of JANX013 in combination with JANX007 in participants with metastatic castration-resistant prostate cancer.
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT07813637
- Sponsor's protocol ID
- PSMA-013-001
- Acronym
- PSMA-013-001
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 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 JANX013 Combined With JANX007 in Participants With Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07813637
- Acronym / sponsor ID
- PSMA-013-001 / PSMA-013-001
- Conditions
- Prostate Cancer, Castration-Resistant Prostate Cancer (CRPC), Metastatic Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer Patients
- Keywords
- mCRPC, Metastatic Castration-Resistant Prostate Cancer, PSMA, Prostate-Specific Membrane Antigen, CD3 T cell engager, T cell engager, Bispecific antibody, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Janux TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 10 Sep 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 JANX013 in combination with JANX007 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
- Model description
- Participants are assigned to sequential cohorts in a dose-escalation phase followed by dose-expansion cohorts evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of JANX013 in combination with JANX007 in participants with metastatic castration-resistant prostate cancer.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: JANX013, Drug: JANX007Participants receive JANX013 in combination with JANX007 administered at increasing dose levels per cohort |
| Dose Expansion | Experimental | Drug: JANX013, Drug: JANX007Participants receive JANX013 in combination with JANX007. Participants 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 (7 listed)
- Male participants ≥ 18 years of age at the time of signing informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Have received at least 1 novel ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, or darolutamide) in any setting and have received at least 1 taxane regimen (in any setting), or who are medically unsuitable or have actively refused treatment with a taxane regimen.
- Must be in the first-line or second-line setting for mCRPC or metastatic androgen pathway modulation resistant disease and must have received 1 novel ARPI in any setting.
- Adequate organ function
Key exclusion criteria (3 listed)
- Prior treatment with any chimeric antigen receptor (CAR) T-cell therapy, any approved or investigational TCE, or any T-cell costimulatory agent
- Clinically significant cardiovascular disease
- Prior solid organ transplant
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 |
|---|---|---|
| JANX013JANX013 will be administered via IV dosing. | Drug | Dose Escalation |
| JANX007JANX007 will be administered via IV dosing. | Drug | Dose Escalation |
| JANX013JANX013 will be administered via IV dosing | Drug | Dose Expansion |
| JANX007JANX007 will be administered via IV dosing | Drug | Dose Expansion |
Primary outcome
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Time frame: 2 years
Incidence of cytokine release syndrome (CRS)
Time frame: 2 years
Cytokine release syndrome (CRS) assessed according to ASTCT criteria.
8 secondary outcomes
Area under the curve from 0 to t of JANX013 and JANX007
Time frame: Up to 2 years
Maximum observed concentration of JANX013 and JANX007
Time frame: Up to 2 years
Time to maximum concentration of JANX013 and JANX007
Time frame: Up to 2 years
Number of participants who develop anti-drug antibodies (ADAs) against JANX013 and JANX007
Time frame: Up to 2 years
Prostate-specific antigen (PSA) response
Time frame: Up to 2 years
Radiographic progression-free survival (rPFS)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Disease control rate (DCR)
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 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JANX013 and JANX007 in people with Prostate Cancer and Castration-Resistant Prostate Cancer (CRPC), run by Janux Therapeutics at 1 site 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 7 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 17 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 1 site 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, PSMA-013-001_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 adverse events (AEs), serious adverse events (SAEs), and 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 17 Sep 2026.