A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer (NCT05067140) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
United States152 participantsStarted 2021-09-02
Plain-language summary
A Phase 1/2 study to evaluate the safety and efficacy of ARV-766 given by mouth alone or in combination with abiraterone in men with metastatic prostate cancer.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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…
What they're measuring
1
Part A: Incidence of Dose Limiting Toxicities of ARV-766
Timeframe: 28 Days
2
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766
Timeframe: 28 Days
3
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766
Timeframe: 28 Days
4
Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC
Timeframe: 12 Weeks
5
Part C: Incidence of Dose Limiting Toxicities of ARV-766 / abiraterone combination
Timeframe: 28 Days
6
Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 / abiraterone combination
Timeframe: 28 Days
7
Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 / abiraterone combination