trial of arv-110 in patients with metastatic castration resistant prostate cancer

Conditions: Prostate Cancer Metastatic

Summary: phase 1/2 dose escalation study to assess the safety and tolerability of arv-110 in men with mcrpc who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).


Eligibility criteria:
inclusion criteria: part a: * 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). part b: * 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 received at least one but no more than two prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone) for crpc. * patients must have received no more than one prior chemotherapy regimen in each of the following settings: castrate sensitive and castrate resistant prostate cancer. * patients must have ongoing adt with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration). part b - phase 2 expansion cohort subgroup 4 * patient has received only one prior ar second generation therapy (e.g., abiraterone or enzalutamide) either as treatment for cspc or crpc and no more than 1 regimen in crpc setting. * no prior chemotherapy exclusion criteria: part a: * 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. part b: * 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.

Keywords: metastatic prostate cancer castrate-resistant prostate cancer mcrpc adenocarcinoma of the prostate bavdegalutamide