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ARV-110

Phase 1

Prostate Cancer Metastatic | Small molecule | Oncology |Arvinas, Inc.|Last Updated: Apr 1, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment248

FDA Designations

No designations recorded

Clinical trial landscape

ARV-110 · 1 trial · 1 indication

Phase 1 1
NCT03888612Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate CancerProstate Cancer Metastatic
COMPLETED248 Analytics
PHASE1COMPLETED
Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer
Prostate Cancer MetastaticUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Incidence of Dose Limiting Toxicities of ARV-110
28 Days

First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug

Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110
28 Days

Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.

Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110
28 Days

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.

Part B: Measurement of PSA response rate per PCWG3 accessing anti-tumor activity of ARV-110
12 Weeks

PSA response rate per PCWG3.

Part B: Measurement of overall RECIST response rate accessing the anti-tumor activity of ARV-110
12 Weeks

Overall RECIST response rate in patients with measurable disease at baseline.

Part B: To evaluate the clinical anti-tumor activity of ARV-110 in patients with mCRPC
12 Weeks

To evaluate the clinical anti-tumor activity (PSA response rate per PCWG3, Overall RECIST RR, rPFS, and PFS) of ARV-110 in patients with mCRPC in different subgroups of patients with mCRPC with predefined tumor genomic and molecular profiles or based on prior therapy.

Secondary Endpoints

Part A: Anti-tumor activity based on the overall PSA response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
12 Weeks
Part A: Anti-tumor activity based on the overall RECIST response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
12 Weeks
Part A: Anti-tumor activity based on the progression free survival in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
12 Weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARV-110EXPERIMENTALPart A: Oral tablet(s), once or twice daily in 28 day cycles Part B: Oral tablet(s), once or twice daily in 28 day cycles

Interventions

NameTypeDescription
ARV-110DRUGPart A: Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment Part B: Daily oral dosage and schedule at a recommended Phase 2 dose based on data from Part A
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites54

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. *...

Countries:United States
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Competitive Landscape -Prostate Cancer 252 trials (matched to "Prostate Cancer Metastatic")

Frequently asked questions about ARV-110

What is ARV-110 used for?

ARV-110 is an investigational small molecule being developed for the treatment of metastatic castration resistant prostate cancer. It is designed to target and degrade the androgen receptor, a key driver of prostate cancer growth. The drug is currently in clinical development and has not been approved by regulatory authorities.

What does ARV-110 target?

ARV-110 targets the androgen receptor, a protein that plays a critical role in the growth and progression of prostate cancer. By degrading this receptor, ARV-110 aims to disrupt cancer cell signaling and inhibit tumor growth. This mechanism is being evaluated in patients with metastatic castration resistant prostate cancer.

Who makes ARV-110?

ARV-110 is being developed by Arvinas, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARVN. The company is focused on developing targeted protein degradation therapies for the treatment of cancer and other diseases.

What phase is ARV-110 in?

ARV-110 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received FDA approval and is still being studied for safety and efficacy in patients with metastatic castration resistant prostate cancer.

What clinical trials is ARV-110 in?

ARV-110 has been studied in a Phase 1 clinical trial with the identifier NCT03888612, titled "Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer." This trial, conducted in the United States, enrolled 248 male patients aged 18 years and older and has been completed.