Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARV-110 · 1 trial · 1 indication
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
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
PSA response rate per PCWG3.
Overall RECIST response rate in patients with measurable disease at baseline.
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.
| Arm | Type | Description |
|---|---|---|
| ARV-110 | EXPERIMENTAL | Part 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 |
| Name | Type | Description |
|---|---|---|
| ARV-110 | DRUG | Part 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 |
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. *...
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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.
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.
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.
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.
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.