Clinical trial NCT05067140: A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
Official title: A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 Monotherapy and in Combination With Abiraterone in Patients With Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer Metastatic
Keywords: Metastatic Prostate Cancer
Castrate-Resistant
Prostate Cancer
mCRPC adenocarcinoma of prostate
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Castrate-Sensitive
mCSPC adenocarcinoma of prostate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-10-05
Enrollment: 152
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 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

Primary outcomes:
measure: Part A: Incidence of Dose Limiting Toxicities of ARV-766
timeFrame: 28 Days
measure: Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766
timeFrame: 28 Days
measure: Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766
timeFrame: 28 Days
measure: Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC
timeFrame: 12 Weeks
measure: Part C: Incidence of Dose Limiting Toxicities of ARV-766 / abiraterone combination
timeFrame: 28 Days
measure: Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 / abiraterone combination
timeFrame: 28 Days
measure: Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 / abiraterone combination
timeFrame: 28 Days
measure: Part D: To evaluate the clinical anti-tumor activity of ARV-766 / abiraterone combination in patients with NHA-naïve mPC
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Clinical Trial Site
state: California
city: Fresno
country: United States
facility: Clinical Trial Site
state: California
city: La Jolla
country: United States
facility: Clinical Trial Site
state: California
city: Orange
country: United States
facility: Clinical Trial Site
state: California
city: Santa Monica
country: United States
facility: Clinical Trial Site
state: California
city: New Haven
country: United States
facility: Clinical Trial Site
state: Connecticut
city: Washington
country: United States
facility: Clinical Trial Site
state: District of Columbia
city: Lake Mary
country: United States
facility: Clinical Trial Site
state: Florida
city: Chicago
country: United States
facility: Clinical Trial Site
state: Illinois
city: New Orleans
country: United States
facility: Clinical Trial Site
state: Louisiana
city: Baltimore
country: United States
facility: Clinical Trial Site
state: Maryland
city: Boston
country: United States
facility: Clinical Trial Site
state: Massachusetts
city: Detroit
country: United States
facility: Clinical Trial Site
state: Michigan
city: Buffalo
country: United States
facility: Clinical Trial Site
state: New York
city: New York
country: United States
facility: Clinical Trial Site
state: New York
city: Philadelphia
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Nashville
country: United States
facility: Clinical Trial Site
state: Tennessee
city: San Antonio
country: United States
facility: Clinical Trial Site
state: Texas
city: Charlottesville
country: United States
facility: Clinical Trial Site
state: Virginia
city: Fairfax
country: United States
facility: Clinical Trial Site
state: Virginia
city: Madison
country: United States
facility: Clinical Trial Site
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: