Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARV-806 · 1 trial · 2 indications
Number of participants within a dose escalation cohort with adverse events (AEs) meeting protocol defined dose limiting toxicities during cycle 1 (28 days).
AEs as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\]), timing, seriousness, and relationship to study intervention as a measure of safety and tolerability
ORR is a parameter measuring the anti-tumor activity of ARV-806. ORR is the percentage of participants for whom the study treatment resulted in a complete response or partial response of the disease under study. It is measured using CT/MRI and RECIST 1.1 criteria per investigator assessment.
| Arm | Type | Description |
|---|---|---|
| Phase 1/Part A Monotherapy (Dose Escalation) | EXPERIMENTAL | Participants will receive ARV-806 at the assigned doses and regimen (weekly or every 2 weeks). |
| Phase 2/Part B Monotherapy (Dose Expansion) | EXPERIMENTAL | Participants will receive ARV-806 at one of up to 2 dose levels/regimens selected from Part A) |
| Name | Type | Description |
|---|---|---|
| ARV-806 | DRUG | Intravenous infusion at assigned dose and dosing schedule |
Inclusion Criteria: Part A: * Histological or cytological diagnosis of unresectable or metastatic solid tumor malignancy, AND * Must have evidence of KRAS G12D mutation in tumor tissue or blood (circulating tumor deoxyribonucleic acid \[ctDNA\]), AND * Must have received prior standard-of-care (SO...
Top 3 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Tango Therapeutics, Inc. | TNGX | 1 | PHASE1 | TNG462 |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 1 | PHASE1 | AN9025 |
ARV-806 is an investigational small molecule being developed by Arvinas, Inc. for advanced solid tumors that carry a KRAS G12D mutation. It is in Phase 1 clinical development and has not been approved by the FDA. It is being studied in adults 18 years and older.
ARV-806 is being studied for the treatment of advanced solid cancers that have a KRAS G12D mutation. It is an investigational therapy in Phase 1 development and is not approved for any indication. The trial enrolls adults with advanced cancer whose tumors carry this mutation.
ARV-806 targets KRAS G12D, a mutated form of the KRAS protein found in certain solid tumors. Arvinas is developing it as a small molecule directed at this specific mutation. Targeting KRAS G12D is intended to address cancers driven by this mutation.
Arvinas, Inc. is developing ARV-806. The company trades on the Nasdaq under the ticker ARVN. Arvinas is the sponsor of the Phase 1 study evaluating the drug in patients with advanced cancer that has the KRAS G12D mutation.
ARV-806 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 study is currently active but not recruiting participants, and no trials of ARV-806 have been completed.
ARV-806 is being evaluated in one clinical trial, NCT07023731, titled A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation. The Phase 1 trial is active but not recruiting, plans to enroll 76 participants, and is conducted in the United States.