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...