Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-324 · 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...
ABBV-324 is an investigational small molecule being developed by AbbVie Inc. for the treatment of hepatocellular cancer. It is administered by intravenous infusion and is currently in Phase 1 clinical development. The drug is also being studied in squamous-cell non-small cell lung cancer.
ABBV-324 is being evaluated as a treatment for hepatocellular cancer, the most common form of primary liver cancer. It is an investigational therapy and has not been approved for any indication. The Phase 1 trial also includes patients with squamous-cell non-small cell lung cancer.
ABBV-324 is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the ongoing Phase 1 clinical trial evaluating the drug in hepatocellular cancer and squamous-cell non-small cell lung cancer.
ABBV-324 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The single active trial is currently recruiting participants and is designed to assess adverse events and changes in disease activity.
ABBV-324 is being studied in one active clinical trial, NCT06858813. This Phase 1 study is recruiting adults with hepatocellular cancer or squamous-cell non-small cell lung cancer. It is an active-controlled, randomized trial with an estimated enrollment of 232 participants across the United States, China, Israel, Japan, Puerto Rico, Spain, and Taiwan.