Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Budigalimab · 2 trials · 2 indications
BOR is defined as a subject achieving confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by investigators at any time prior to subsequent anticancer therapy.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalization, Grade 4 being life-threatening requiring immediate intervention and Grade 5 being death related to an AE.
Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines \[which utilizes the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) grading scale\] but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.
Maximum Serum Concentration (Cmax) of Budigalimab.
Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.
Area Under the Plasma Concentration-time Curve (AUC).
Terminal phase elimination half-life (t1/2)
| Arm | Type | Description |
|---|---|---|
| Arm 1: Lenvatinib or Sorafenib | ACTIVE_COMPARATOR | Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period. |
| Arm 2: Livmoniplimab Dose A + Budigalimab | EXPERIMENTAL | Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period. |
| Arm 3: Livmoniplimab Dose B + Budigalimab | EXPERIMENTAL | Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period. |
| Group 1: Placebo SC + Placebo IV | EXPERIMENTAL | Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo. |
| Group 2: Budigalimab (SC) + Placebo IV | EXPERIMENTAL | Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo. |
| Group 3: Budigalimab SC + Placebo IV | EXPERIMENTAL | Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo. |
| Group 4: Placebo SC + Budigalimab IV | EXPERIMENTAL | Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab. |
| Name | Type | Description |
|---|---|---|
| Budigalimab | DRUG | Intravenous (IV) Infusion |
| Livmoniplimab | DRUG | Intravenous (IV) Infusion |
| Lenvatinib | DRUG | Oral: Capsule |
| Sorafenib | DRUG | Oral: Tablet |
| Placebo | DRUG | Subcutaneous (SC) |
Inclusion Criteria: * Child-Pugh A classification. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * Received an immune checkpoint inhibitor in first-line (1L) hepatocellular carcinoma (HCC) treatment regimen. * Adequate hematologic and end-organ function. * Tissue biopsy ...