JANX014 for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, JANX014, for men with a type of prostate cancer that has spread and continues to grow despite hormone therapy. The main goal is to determine if JANX014 is safe and to identify the best dose patients can tolerate. The study begins with small doses, gradually increasing to find the optimal amount. Men with this specific type of prostate cancer who have tried other treatments without success might be suitable candidates for the trial. Participants must have adequate organ function and no significant heart issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that JANX014 is likely to be safe for humans?
Research has shown that JANX014 is a new treatment under testing for prostate cancer. In earlier studies with a similar treatment, JANX007, patients did not experience serious side effects like severe cytokine release syndrome (CRS). CRS can cause symptoms such as fever and tiredness, but no severe cases were reported in those studies.
Since JANX014 is in the first phase of testing, researchers are still assessing its safety in humans. Early studies focus on how well people tolerate the treatment and what side effects might occur. This phase often involves testing different doses to determine what is safe for most people.12345Why do researchers think this study treatment might be promising for prostate cancer?
Unlike the standard treatments for prostate cancer, which typically include hormone therapy, chemotherapy, and radiation, JANX014 offers a unique approach by targeting the cancer cells with precision. Researchers are excited about JANX014 because it involves a novel mechanism that precisely zeroes in on cancer cells while minimizing damage to healthy cells. This targeted approach not only has the potential to be more effective but also reduces the side effects often associated with traditional cancer treatments. By escalating doses to determine the most effective yet tolerable level, JANX014 could revolutionize how prostate cancer is managed.
What evidence suggests that JANX014 might be an effective treatment for prostate cancer?
Research has shown that JANX014 is a promising new treatment for prostate cancer. The trial includes a Dose Escalation arm, where researchers will administer JANX014 at increasing dose levels to determine the maximum tolerated dose, and a Dose Expansion arm, where participants will receive doses previously declared tolerable. Studies of a similar drug, JANX007, have shown it to be safe, with no severe immune reactions at the doses used. Early results suggest that JANX014 targets a protein called PSMA on prostate cancer cells, helping the immune system attack the cancer more effectively. In previous studies, about 78% of patients experienced a significant drop in prostate-specific antigen (PSA) levels, indicating decreased cancer activity. These findings support the potential of JANX014 for treating advanced prostate cancer resistant to standard hormone therapy.13456
Are You a Good Fit for This Trial?
This trial is for adult men (18+) with advanced prostate cancer that has spread and no longer responds to hormone therapy. Participants must have tried certain treatments before, unless they can't or choose not to. They also need to have working major organs.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
JANX014 will be administered at increasing dose levels per cohort to determine the maximum tolerated dose
Dose Expansion
Participants will be dosed at levels previously declared tolerable
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JANX014
Trial Overview
The study is testing a new drug called JANX014 in people with metastatic castration-resistant prostate cancer. It's an early-phase, open-label trial looking at safety, how the body processes the drug, and any signs it works.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will be dosed at levels previously declared tolerable.
JANX014 will be administered at increasing dose levels per cohort to determine the maximum tolerated dose.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janux Therapeutics
Lead Sponsor
Citations
1.
investors.januxrx.com
investors.januxrx.com/investor-media/news/news-details/2026/Janux-Therapeutics-Announces-First-Participant-Dosed-in-Phase-1-Study-of-JANX014/default.aspxJanux Therapeutics Announces First Participant Dosed in ...
JANX014 is a double-masked, prostate-specific membrane antigen (PSMA) directed T cell engager (TCE) designed to leverage Janux's tumor-activated ...
First Patient Dosed in JANX014 Trial in Metastatic CRPC
Early clinical data with JANX007 demonstrated a favorable safety profile, with no grade 3 cytokine release syndrome (CRS) observed at clinically ...
Study of JANX014 in Subjects With Metastatic Castration- ...
This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the ...
First patient receives JANX014 dose in Janux's trial for ...
JANX007 clinical data showed no Grade 3 cytokine release syndrome at clinically relevant doses using current mitigation.
5.
urologytimes.com
urologytimes.com/view/psma-targeted-t-cell-engager-enters-phase-1-testing-in-mcrpcPSMA-targeted T-cell engager enters phase 1 testing in ...
JANX014 is designed with both the PSMA-binding and CD3 domains masked, an approach intended to enable tumor-selective T-cell activation and ...
EX-99.1
The Company is also advancing additional PSMA-targeted programs, including JANX014, a double-masked PSMA TRACTr being evaluated in a Phase 1 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.