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FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 5 of 7 entries
    • Study description expanded, about 2 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 41 to confirmed 44
    • Primary and study completion dates: Apr 30, 2027 to Jul 31, 2027
    • Site details revised
    v11
  3. Enrollment target: 36 to 41
    • Primary and study completion dates: Mar 31, 2027 to Apr 30, 2027
    v10
  4. Interventions: Enzalutamide (Biological), FOR46 (Biological), Pegfilgrastim (Drug) to Blood Samples (Procedure), Enzalutamide (Biological), FOR46 (Biological), Pegfilgrastim (Drug)
    • Eligibility criteria revised
    • Collaborators: 1 to 2
    • Study description expanded, about 1 word
    v9
  5. Eligibility criteria shortened, about 5 wordsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria expanded, about 20 wordsv7
  2. Re-verified, no change to tracked fieldsv6
  3. Interventions: Enzalutamide (Biological), FOR46 (Biological) to Enzalutamide (Biological), FOR46 (Biological), Pegfilgrastim (Drug)v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2022 to Jan 19, 2022
    • Site details revised
    v4
  5. Start date: Dec 1, 2021 to Feb 1, 2022
    • Primary and study completion dates: Jan 31, 2027 to Mar 31, 2027
    v3
  6. Primary and study completion dates: Dec 31, 2025 to Jan 31, 2027
    • Start date: Oct 1, 2021 to Dec 1, 2021
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Rahul Aggarwal
5 trials monitored
See 1 trial at risk
Prostate Cancer
2,546 trials monitored
See 172 trials at risk
This is a Phase 1b/2 study evaluating FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) after prior progression on abiraterone. FOR46 is designed to target and bind to CD46, a transmembrane cellular protein expressed at moderate or high levels in numerous cancer types. The investigators hypothesize that the combination of FOR46 plus enzalutamide will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients.
Trial Details
NCT Number NCT05011188
Lead Sponsor Rahul Aggarwal
Collaborators: Fortis Therapeutics, Inc., Kyntra Bio
Conditions
(from sponsor)		 Metastatic Castration-resistant Prostate Cancer, Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov