A Phase 1, Open-label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients With Metastatic Castration-resistant Prostate Cancer Who Have Progressed on at Least Two Prior Systemic Therapies.
- Study HIC#:2000024729
- Last Updated:07/15/2021
This is a first in human, dose escalation study and will assess the safety and tolerability of ARV 110 in men with mCRPC who have progressed on at least 2 prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).
- Age18 years and older
- GenderMale only
- Start Date06/10/2020
- End Date03/31/2021
Trial Purpose and Description
Primary Outcome Measures :
- Incidence of Dose Limiting Toxicities of ARV-110 [ Time Frame: 28 Days ]First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug
- Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110 [ Time Frame: 28 Days ]Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.
- Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110 [ Time Frame: 28 Days ]Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
- Patients must be male and at least 18 years of age at the time of signing the informed consent.
- Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate.
- Patients must have progressed on at least 2 prior approved systemic therapies for CRPC (at least one must be abiraterone or enzalutamide).
- Patients with progressive mCRPC
- Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
- Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses)
- Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
- Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study
- Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are ineligible if they received any other type of anti cancer agent (except agents to maintain castrate status) within 2 weeks before first dose of study drug.