A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer

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Arvinas

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Prostate Cancer Metastatic

Treatments

Drug: ARV-766 + Abiraterone Part C&D
Drug: ARV-766 Part A&B

Study type

Interventional

Funder types

Industry

Identifiers

NCT05067140
ARV-766-mCRPC-101

Details and patient eligibility

About

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.

Enrollment

220 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

220 participants in 2 patient groups

ARV-766
Experimental group
Description:
Oral tablets, once daily in 28 day cycles
Treatment:
Drug: ARV-766 Part A&B
ARV-766 + Abiraterone
Experimental group
Description:
Oral tablets, once daily in 28 day cycles
Treatment:
Drug: ARV-766 + Abiraterone Part C&D

Trial contacts and locations

23

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Central trial contact

Arvinas Androgen Receptor, Inc.

Data sourced from clinicaltrials.gov

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