Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC
A Phase 1 Open-Label, Multicenter Study of JANX013 Combined With JANX007 in Participants With Metastatic Castration Resistant 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 early study tests JANX013 with JANX007 in adults with prostate cancer that has spread and keeps growing despite treatment to lower testosterone. Researchers will check safety, how the body handles the drugs, and early signs that they may work.
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).
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 consent form.
- Prostate adenocarcinoma, a type of prostate cancer, confirmed by tissue or cell tests.
- For the dose-finding part: Have had at least 1 newer drug that blocks male hormones, such as abiraterone, enzalutamide, apalutamide, or darolutamide.
- For the dose-finding part: Have had taxane chemotherapy, cannot receive it for medical reasons, or have actively refused it.
- For the expanded-testing part: Be receiving a first or second treatment for prostate cancer that has spread and resists treatment to lower or block male hormones.
- For the expanded-testing part: Have had 1 newer drug that blocks male hormones.
- For the expanded-testing part: Have organs that work well enough.
Who can't join
- Past treatment with CAR T-cell therapy, which uses changed immune cells to fight cancer.
- Past treatment with an approved or experimental T-cell engager, which links immune cells to cancer cells, or a drug that boosts T-cell activity.
- Significant heart or blood vessel disease.
- A past transplant of a solid organ, such as a kidney or liver.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
TN
- Sarah Cannon Research Institute · Nashville, TN 37203More trials in Nashville