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NCT Number: NCT07813637

Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Treatment and study plan

JANX013

Drug

JANX013 will be administered via IV dosing.

JANX007

Drug

JANX007 will be administered via IV dosing.

Primary outcomes

  1. Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

    Time frame: 2 years

  2. Incidence of cytokine release syndrome (CRS)

    Time frame: 2 years

    Cytokine release syndrome (CRS) assessed according to ASTCT criteria.

Secondary outcomes

  1. Area under the curve from 0 to t of JANX013 and JANX007

    Time frame: Up to 2 years

  2. Maximum observed concentration of JANX013 and JANX007

    Time frame: Up to 2 years

  3. Time to maximum concentration of JANX013 and JANX007

    Time frame: Up to 2 years

  4. Number of participants who develop anti-drug antibodies (ADAs) against JANX013 and JANX007

    Time frame: Up to 2 years

  5. Prostate-specific antigen (PSA) response

    Time frame: Up to 2 years

  6. Radiographic progression-free survival (rPFS)

    Time frame: Up to 2 years

  7. Duration of response (DOR)

    Time frame: Up to 2 years

  8. Disease control rate (DCR)

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Janux Therapeutics, MD

CONTACT

[email protected]

1-858-206-8471

Sponsors and collaborators

Lead sponsor

Janux Therapeutics

Industry

Registry information

Official study title

A Phase 1 Open-Label, Multicenter Study of JANX013 Combined With JANX007 in Participants With Metastatic Castration Resistant Prostate Cancer

Acronym: PSMA-013-001

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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