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Recruiting

NCT Number: NCT07545811

Study of JANX014 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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Nashville, Tennessee, 37203, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

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: 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.

Exclusion criteria

  • 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

Treatment and study plan

JANX014

Biological

JANX014 will be administered via IV dosing

Primary outcomes

  1. Incidence of Dose Limiting Toxicities (DLTs)

    Time frame: 2 years

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

    Time frame: 2 years

Secondary outcomes

  1. Area under the curve from time 0 to t of JANX014 (AUC0-t)

    Time frame: up to 2 years

  2. Maximum observed concentration of JANX014 (Cmax)

    Time frame: up to 2 years

  3. Number of participants who develop anti-drug antibodies against JANX014

    Time frame: up to 2 years

  4. Prostate Specific Antigen (PSA) response

    Time frame: up to 2 years

  5. Overall Response Rate

    Time frame: up to 2 years

  6. Duration of Response

    Time frame: up to 2 years

  7. Radiographic Progression Free Survival (rPFS)

    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 JANX014 in Participants With Prostate Cancer

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 22, 2026
Registry last updated
Apr 22, 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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