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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug for prostate cancer that has spread and is resistant to hormone therapy. They will study how well the drug works and if it is safe.
Who is the study for?
This trial is for adult men with metastatic castration-resistant prostate cancer who have already tried at least one novel anti-androgen therapy and a taxane regimen, or cannot take taxane due to medical reasons. They must have a PSMA expressing tumor, no significant heart disease, no organ transplants, and no active serious infections.
What is being tested?
The study tests JANX007's safety, how well it's tolerated by the body (tolerability), its behavior in the body (pharmacokinetics), its effect on the body (pharmacodynamics), and initial effectiveness in treating advanced prostate cancer that resists standard treatments.
What are the potential side effects?
As this is a first-in-human study of JANX007, specific side effects are not yet known but may include typical reactions related to immune therapies such as fatigue, fever, allergic reactions or issues affecting organs where PSMA is present.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Duration of Response
Overall Response Rate
Overall Survival
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: ExpansionExperimental Treatment1 Intervention
IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).
Group II: Dose EscalationExperimental Treatment1 Intervention
IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.
Group III: Backfill ExpansionExperimental Treatment1 Intervention
IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.
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Who is running the clinical trial?
Janux TherapeuticsLead Sponsor
1 Previous Clinical Trials
130 Total Patients Enrolled
Janux Therapeutics, MDStudy DirectorJanux Therapeutics
1 Previous Clinical Trials
130 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious infections.My organs are working well.I don't have any health issues that could affect the study's safety or results.I have had a solid organ transplant.My prostate cancer was confirmed by a lab test.I am a man aged 18 or older.I have previously received PSMA-targeted therapy for cancer.I have a serious heart condition.My prostate cancer has worsened despite anti-androgen therapy and chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
- Group 2: Expansion
- Group 3: Backfill Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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