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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Tango Therapeutics, Inc. | TNGX | 1 | PHASE1 | TNG462, RMC-9805, RMC-6236, mFOLFIRINOX, gemcitabine/nab-paclitaxel |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 1 | PHASE1 | AN9025 |
| Myriad Genetics, Inc. | MYGN | 1 | PHASE1 | Melphalan, BCNU, Vitamin B12B, Vitamin C |
ARV-806 is an investigational small molecule being developed for the treatment of advanced solid cancers that have the KRAS G12D mutation. It is currently in Phase 1 clinical development and has not been approved by the FDA.
ARV-806 targets the KRAS G12D mutation, a specific genetic alteration found in certain cancers. By targeting this mutation, the drug aims to address tumors that carry this particular KRAS variant.
ARV-806 is being developed by Arvinas, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ARVN. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
ARV-806 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still being studied in clinical trials.
ARV-806 is being studied in a Phase 1 clinical trial with the identifier NCT07023731. This trial evaluates the drug in adults with advanced cancer that has the KRAS G12D mutation, with an enrollment of 159 participants in the United States.