A Phase I/II Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 in Patients With Metastatic Castration-Resistant Prostate Cancer

Study Identifier:
CJSB462A12101
CT.gov Identifier:
NCT05067140
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruitment Complete

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Study Summary

to evaluate the safety and efficacy of ARV-766 given by mouth in men with metastatic castration-resistant prostate cancer who have progressed on prior approved systemic therapies

To evaluate the safety and efficacy of ARV-766 in men with metastatic castration-resistant prostate cancer.

To evaluating the safety and tolerability of ARV-766, 2 doses (100 mg and 300 mg administered orally once daily in 28-day cycles) were selected for the phase 2 cohort expansion.

In part A (dose escalation), to assess safety and tolerability and select recommended phase 2 doses (RP2Ds);

in part B (cohort expansion), to evaluate the antitumor activity of the RP2Ds

Part C of this study will assess the addition of ARV-766 to abiraterone for the treatment of NHA-naïve mCRPC or mCSPC.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: ARV-766
    • Read More
  • Drug: Part B: Oral tablet(s) once daily in 28 day cycles.
  • Drug: Part D: Combination administered once daily in 28 day cycles.
  • Drug: Parts C&D: Participants will also receive concomitant corticosteroid and ADT therapy of investigator choice/patient preference
  • Drug: In part A (dose escalation) Patients were given ARV-766 orally once daily (QD) in ascending doses
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Part A,B,C and D:
    • Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
    • Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Part A:
    • Progression on at least 2 prior approved systemic therapies for metastatic prostate cancer (at least one must be a second-generation androgen inhibitor, e.g., abiraterone, enzalutamide, darolutamide, apalutamide).
    • Progressive mCRPC
    • Part B:
    • Participants must have received at least one but no more than three prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone).
    • Participants must have received no more than two prior chemotherapy regimens.
    • Progressive mCRPC
    • Part C & D:
    • • Metastatic castration resistant or sensitive prostate cancer with radiographic evidence of metastatic disease
    • In part A (dose escalation), patients (pts) who had ≥2 prior therapies (including ≥1 NHA)
    • in part B (cohort expansion), pts treated with 1–3 prior NHAs and ≤2 chemotherapy regimens
    • Part C will enroll ≤24 men (aged ≥18 y) with histologically, pathologically, or cytologically confirmed mCRPC or mCSPC, Eastern Cooperative Oncology Group performance status score of 0 or 1, and no prior NHA treatment
    Exclusion criteria
    • Part A and B:
    • Known symptomatic brain metastases requiring steroids (above physiologic replacement doses).
    • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery.
    • Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow.
    • Receipt of an investigational drug(s) within 4 weeks prior to anticipated first dose
    • Systemic anti-cancer therapy within 2 weeks of first dose of study drug (except agents to maintain castrate status). For bicalutamide, mitomycin C, or nitrosoureas the exclusion period must be 6 weeks and for abiraterone 4 weeks.
    • Part C and D
    • • Prior treatment with a second generation NHA

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Prostate