Dose Escalation for Prostate Cancer

Southern Oncology Clinical Research Unit (SoCRU), Bedford Park, Australia
Prostate Cancer+2 More ConditionsJANX007 - Biological
Eligibility
18 - 100
Male

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.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer
  • Castration-resistant Prostate Cancer
  • Prostate Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: 3 years

3 years
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Incidence of Dose Limiting Toxicities (DLT)
Year 3
Area under the concentration time curve to infinity of JANX007 (AUC0-inf)
Maximum observed concentration of JANX007 (Cmax)
Up to 3 years
Duration of Response
Number of participants who develop anti-drug antibodies against JANX007
Overall Response Rate
Overall Survival
Progression Free Survival
Prostate Specific Antigen (PSA) response
Radiographic Progression Free Survival (rPFS)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Dose Escalation
1 of 3
Backfill Expansion
1 of 3
Expansion
1 of 3

Experimental Treatment

90 Total Participants · 3 Treatment Groups

Primary Treatment: Dose Escalation · No Placebo Group · Phase 1

Dose Escalation
Biological
Experimental Group · 1 Intervention: JANX007 · Intervention Types: Biological
Backfill Expansion
Biological
Experimental Group · 1 Intervention: JANX007 · Intervention Types: Biological
Expansion
Biological
Experimental Group · 1 Intervention: JANX007 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

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

Eligibility Criteria

Age 18 - 100 · Male Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Does this trial encompass participants aged 20 and above?

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.