Clinical Trial to Evaluate ARV-766 in Patients With Metastatic Castration-Resistant Prostate Cancer

Sponsor

Arvinas Androgen Receptor, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05067140

Collaborator

(none)

Enrollment

Locations

Arm

45.8

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of ARV-766 in men with metastatic castration-resistant prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Metastatic	Drug: ARV-766	Phase 1

Detailed Description

The study will evaluate ARV-766 given once or twice daily to cohorts of patients in escalating doses. Each dose level will have safety assessed and if found safe and tolerable, the next cohort of patients will be enrolled at a higher dose level. Increasing dose levels will be evaluated until the highest safe dose is identified. Patients treated at lower doses may increase to the next higher dose level once it is determined to be safe, provided they have been on their current dose for 28 or more days and have no major side effects.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

Subsequent dose level is determined by the Cohort Review Committee after the initial starting dose cohort and each subsequent dose cohort completes the first 28 days of treatmentSubsequent dose level is determined by the Cohort Review Committee after the initial starting dose cohort and each subsequent dose cohort completes the first 28 days of treatment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 in Patients With Metastatic Castration-Resistant Prostate Cancer

Actual Study Start Date :

Sep 2, 2021

Anticipated Primary Completion Date :

Dec 6, 2024

Anticipated Study Completion Date :

Jun 27, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ARV-766 Oral tablet(s), once or twice daily in 28 day cycles	Drug: ARV-766 Daily dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment.

Arm

Intervention/Treatment

Experimental: ARV-766

Oral tablet(s), once or twice daily in 28 day cycles

Drug: ARV-766

Daily dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment.

Outcome Measures

Primary Outcome Measures

Incidence of Dose Limiting Toxicities of ARV-766 [28 Days]
First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug
Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 [28 Days]
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 [28 Days]
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
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
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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trial Site	La Jolla	California	United States	92037
2	Clinical Trial Site	New Haven	Connecticut	United States	06510
3	Clinical Trial Site	Boston	Massachusetts	United States	02114
4	Clinical Trial Site	Buffalo	New York	United States	14203
5	Clinical Trial Site	Nashville	Tennessee	United States	37203
6	Clinical Trial Site	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

Arvinas Androgen Receptor, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arvinas Androgen Receptor, Inc.

ClinicalTrials.gov Identifier:

NCT05067140

Other Study ID Numbers:

ARV-766-mCRPC-101

First Posted:

Oct 5, 2021

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Arvinas Androgen Receptor, Inc.

Metastatic Prostate Cancer

Castrate-Resistant

Prostate Cancer

mCRPC adenocarcinoma of prostate

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Mar 17, 2022