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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests JANX014 in people for the first time. It looks at safety, how the drug acts in the body, and early signs that it may work. It is for adult men with prostate cancer that has spread and keeps growing despite treatment to lower male hormones.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 18 or older when they sign the form agreeing to join.
  • Prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue or cell test.
  • Organs must work well enough for the study.
  • For the dose-increase part: cancer has worsened after at least one newer drug that blocks male hormones and at least one taxane treatment (a type of chemotherapy). Men who refused taxane treatment or cannot safely receive it may also qualify.
  • For the dose-expansion part: no more than 2 prior treatments that block male hormones, either before or after the cancer stopped responding to hormone-lowering treatment.
  • For the dose-expansion part: no more than 1 prior taxane treatment while the cancer still responded to hormone-lowering treatment. Men who refused taxane treatment or cannot safely receive it may also qualify.

Who can't join

  • Have had a solid organ transplant.
  • Have had CAR-T cell therapy or T-cell engager therapy, which use immune cells to fight cancer, including approved or experimental treatments.
  • Have had radioligand therapy, which delivers radiation to cancer cells.
  • Have serious heart or blood vessel disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (6)

CA

MO

SC

TN

TX