Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lenvatinib · 1 trial · 2 indications
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Number of Participants with Change in Vital Signs will be assessed.
Number of Participants with Change in ECG will be assessed.
Number of participants with change in clinical laboratory tests will be assessed.
ORR is defined as the percentage of participants with a confirmed Complete Response or partial response(PR) per investigator review according to response evaluation criteria in solid tumors (RECIST) version 1.1.
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose Escalation: ABBV-324 | EXPERIMENTAL | Participants will receive escalating doses of ABBV-324 as part of the approximately 6.5 year study duration. |
| Part 2 Dose Optimization Arm 1: ABBV-324 Dose 1 | EXPERIMENTAL | Participants will receive ABBV-324 dose 1 as part of the approximately 6.5 year study duration. |
| Part 2 Dose Optimization Arm 1: ABBV-324 Dose 2 | EXPERIMENTAL | Participants will receive ABBV-324 dose 2 as part of the approximately 6.5 year study duration. |
| Part 2 Dose Optimization Arm 1: ABBV-324 Dose 3 | EXPERIMENTAL | Participants will receive ABBV-324 dose 3 as part of the approximately 6.5 year study duration. |
| Part 2 Comparator Arm 4: Lenvatinib | ACTIVE_COMPARATOR | Participants will receive lenvatinib as part of the approximately 6.5 year study duration. |
| Name | Type | Description |
|---|---|---|
| Lenvatinib | DRUG | Oral Capsule |
| ABBV-324 | DRUG | Intravenous (IV) Infusion |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Hepatocellular cancer (HCC) only: Child-Pugh A classification within 7 days before Cycle 1, Day 1 dosing. * Laboratory values meeting the criteria outlined in the protocol. * QT interval corrected for he...
Lenvatinib is an investigational small molecule being studied for the treatment of Hepatocellular Cancer (HCC). It is currently in Phase 1 clinical development, with an active trial recruiting adult participants with HCC or squamous-cell non-small cell lung cancer. The drug is administered intravenously and is being evaluated for adverse events and change in disease activity.
Lenvatinib targets FLT1, FLT4, and KDR, which are receptor tyrosine kinases involved in angiogenesis. As an inhibitor of these targets, it is designed to block signaling pathways that promote tumor growth and blood vessel formation. This mechanism is being investigated in the context of hepatocellular cancer and other solid tumors.
Lenvatinib is being developed by AbbVie Inc., a biopharmaceutical company listed on the stock exchange under the ticker ABBV. The company is conducting a Phase 1 clinical trial to assess the safety and efficacy of the drug in adult participants with hepatocellular cancer or squamous-cell non-small cell lung cancer.
Lenvatinib is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and effectiveness. The ongoing Phase 1 study is actively recruiting participants with hepatocellular cancer or squamous-cell non-small cell lung cancer.
Lenvatinib is being evaluated in a single active clinical trial with the identifier NCT06858813. This Phase 1 study is recruiting 232 adult participants with hepatocellular cancer or squamous-cell non-small cell lung cancer across multiple countries, including the United States, China, Israel, Japan, Puerto Rico, Spain, and Taiwan. The trial is active-controlled and randomized.
Lenvatinib is also known as ABBV-324, as indicated in the clinical trial title. The study NCT06858813 evaluates intravenously infused ABBV-324 in adult participants with hepatocellular cancer or squamous-cell non-small cell lung cancer. Both names refer to the same investigational drug being developed by AbbVie Inc.