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JANX007 for Prostate Cancer

Phase 1

Recruiting

Research Sponsored by Janux Therapeutics

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 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)

Incidence of Dose Limiting Toxicities (DLT)

Secondary outcome measures

Area under the concentration time curve to infinity of JANX007 (AUC0-inf)

Duration of Response

Maximum observed concentration of JANX007 (Cmax)

+5 more

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.

Do I qualify?Apply below to find out

Find a Location

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

Media Library

JANX007 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05519449 — Phase 1

Prostate Cancer Research Study Groups: Dose Escalation, Expansion, Backfill Expansion

Prostate Cancer Clinical Trial 2023: JANX007 Highlights & Side Effects. Trial Name: NCT05519449 — Phase 1

JANX007 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05519449 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial encompass participants aged 20 and above?

"This research endeavour is accommodating people aged 18 and up to 100 years old."

Answered by AI

Has the FDA sanctioned dose escalation as a viable therapeutic approach?

"The limited data available suggests that Dose Escalation is safe enough to receive a score of 1 on our team's internal scale. This Phase 1 trial does not provide ample evidence for either efficacy or safety."

Answered by AI

Are there any openings for participants in this clinical investigation?

"Affirmative. According to information hosted on clinicaltrials.gov, the medical trial is still actively seeking out qualified candidates since its initial posting date of September 15th 2022 and last update of September 20th 2022. The research requires 90 participants at one locale for enrollment."

Answered by AI

How many participants are currently included in the experimental protocol?

"Affirmative. The clinical trial is actively recruiting, as evidenced by the data on clinicaltrials.gov which was first posted on September 15th 2022 and most recently updated on September 20th 2022. 90 patients are sought from one medical centre."

Answered by AI

For whom is this clinical experiment accessible?

"This clinical trial is seeking 90 male participants aged 18 and above who are suffering from castration-resistant prostatic cancer. To qualify, they must have progressed after one novel anti-androgen therapy and a taxane containing regimen (or be medically ineligible to receive it). Additionally, the tumor must express PSMA, with adequate organ function being necessary as well as histological or cytological confirmation of prostate adenocarcinoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

2022. "Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05519449.

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