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Virus Therapy

PCUR-101 + ADT for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Pellficure Pharmaceuticals, Inc
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 through study completion, average of 12 months
Awards & highlights
No Placebo-Only Group
Approved for 30 Other Conditions
All Individual Drugs Already Approved

Summary

This trial tests a new drug, PCUR-101, in patients with advanced prostate cancer that doesn't respond to standard treatments. The study aims to find the safest and most effective dose. Once the best dose is identified, more patients will be treated to confirm its safety and effectiveness.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average of 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Occurrence of Dose Limiting Toxicity
Secondary study objectives
Determination of pharmacokinetic parameters - Cmax
Determination of pharmacokinetic parameters - T1/2
Determination of pharmacokinetic parameters - Tmax
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups
Experimental Treatment
Group I: PCUR-101 Dose Expansion Cohort 3Experimental Treatment2 Interventions
PCUR-101 dosed orally once per day in combination with abiraterone (once per day) and prednisone (twice per day) in 28 day cycles
Group II: PCUR-101 Dose Expansion Cohort 2Experimental Treatment2 Interventions
PCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles
Group III: PCUR-101 Dose Expansion Cohort 1Experimental Treatment1 Intervention
PCUR-101 dosed orally once per day in 28 day cycles
Group IV: PCUR-101 Dose EscalationExperimental Treatment1 Intervention
PCUR-101 dosed orally once per day in 28 day cycles. Patients will be enrolled into escalating dose levels during the dose escalation phase
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dutasteride
FDA approved

Find a Location

Who is running the clinical trial?

Pellficure Pharmaceuticals, IncLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

PCUR-101 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04677855 — Phase 1
Prostate Cancer Research Study Groups: PCUR-101 Dose Expansion Cohort 3, PCUR-101 Dose Escalation, PCUR-101 Dose Expansion Cohort 1, PCUR-101 Dose Expansion Cohort 2
Prostate Cancer Clinical Trial 2023: PCUR-101 Highlights & Side Effects. Trial Name: NCT04677855 — Phase 1
PCUR-101 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04677855 — Phase 1
~2 spots leftby Nov 2025
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