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RecruitingInterventionalPhase 1

A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With Prostate Cancer

NCT ID: NCT07545811Sponsor: Janux TherapeuticsLast updated: 2026-04-22

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).

Arms & interventions

  • BiologicalJANX014

    JANX014 will be administered via IV dosing

Outcome measures

Primary

  • Incidence of Dose Limiting Toxicities (DLTs)

    Time frame: 2 years

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

    Time frame: 2 years

Secondary

  • 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

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

Research Site

Nashville, Tennessee, 37203

Recruiting
Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer | Cancerify