Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARV-766 · 1 trial · 1 indication
Number and proportion of participants experiencing dose-limiting toxicities during the DLT evaluation period to assess safety and determine the maximum tolerated dose (MTD) of ARV-766 and/or recommended Phase 2 dose (RP2D)
Number and proportion of participants experiencing dose-limiting toxicities during the DLT evaluation period to determine the recommended dose of ARV-766 in combination with abiraterone
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.
Prostate Specific Antigen 30 (PSA30) Rate is defined as the proportion of participants who achieve a ≥30% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between
Prostate Specific Antigen 50 (PSA50) Rate is defined as the proportion of participants who achieve a ≥50% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between
| Arm | Type | Description |
|---|---|---|
| Part A: ARV-766 Monotherapy (Dose Escalation) | EXPERIMENTAL | Participants with metastatic prostate cancer received escalating dose levels of ARV-766 administered orally to evaluate safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose and/or recommended Phase 2 dose. Participants continued androgen deprivation therapy as clinically indicated. |
| Part B: ARV-766 Monotherapy (Dose Expansion) | EXPERIMENTAL | Participants with metastatic castration-resistant prostate cancer received ARV-766 administered orally at selected dose levels to further evaluate antitumor activity, safety, tolerability, and pharmacokinetics. Participants continued androgen deprivation therapy as clinically indicated. |
| Part C: ARV-766 + Abiraterone | EXPERIMENTAL | Participants received ARV-766 in combination with abiraterone acetate and a corticosteroid (prednisone or prednisolone) to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of the combination regimen. Participants continued androgen deprivation therapy as clinically indicated. |
| Name | Type | Description |
|---|---|---|
| ARV-766 | DRUG | Parts A and C: Daily oral dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment. Part B: 100mg or 300mg oral tablet(s) once daily in 28 day cycles. |
| Abiraterone | DRUG | Abiraterone is administered orally in combination with ARV-766, typically on an empty stomach with water, in accordance with prescribing information and standard clinical practice. |
| Corticosteroid (e.g., prednisone/prednisolone) | DRUG | Prednisone or prednisolone was administered in accordance with local prescribing information during treatment with abiraterone acetate. |
| Androgen Deprivation Therapy (ADT) | OTHER | Ongoing androgen deprivation therapy, including luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or prior orchiectomy, is maintained per investigator choice or patient preference. |
Key Inclusion Criteria for Parts A, B, and C: * Participants must be able to take oral medication without crushing, dissolving, or chewing tablets * Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate * Progression on approved systemic therapies for meta...
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ARV-766 is an investigational small molecule being studied for the treatment of metastatic prostate cancer. It is currently in Phase 1 clinical development, with an active trial evaluating its safety and efficacy in men with this condition.
ARV-766 is a small molecule designed to target and degrade specific proteins involved in cancer growth. By promoting the breakdown of these proteins, it aims to inhibit tumor progression in metastatic prostate cancer. The exact molecular target is not disclosed in available information.
ARV-766 is being developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's potential in treating metastatic prostate cancer.
ARV-766 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess its safety, tolerability, and preliminary efficacy in patients with metastatic prostate cancer.
ARV-766 is being studied in a Phase 1 clinical trial with the identifier NCT05067140. This trial, titled 'A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer,' is active but not recruiting, with an enrollment of 164 participants in the United States.
ARV-766 is a distinct investigational compound developed by Novartis. It is not known to be the same as any other marketed drug. Its unique mechanism and chemical structure differentiate it from existing therapies for metastatic prostate cancer.