Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Budigalimab, Budiglimab
ABBV-181 · 4 trials · 5 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.
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
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)
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.
Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome.
Maximum Observed Concentration (Cmax) of ABBV-181.
Time to Cmax (Tmax) of ABBV-181.
Observed Concentration (Ctrough) at the end of the dosing intervals for ABBV-181.
Area Under the Curve (AUCtau) during the dosing intervals for ABBV-181.
Half-life (t1/2) of ABBV-181 following the last dose.
| 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. |
| Combo 1 | EXPERIMENTAL | TTX-030 plus budigalimab plus mFOLFOX6 |
| Combo 2 | EXPERIMENTAL | TTX-030 plus budigalimab plus docetaxel |
| Combo 3 | EXPERIMENTAL | TTX-030 plus mFOLFOX6 |
| Combo 4 | EXPERIMENTAL | TTX-030 plus pembrolizumab |
| Combo 5 | EXPERIMENTAL | TTX-030 plus budigalimab (selected tumors evaluated in expansion) |
| Combo 6 | EXPERIMENTAL | TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine |
| Combo 7 | EXPERIMENTAL | TTX-030 plus nab-paclitaxel + gemcitabine |
| Combo 8 | EXPERIMENTAL | Budigalimab plus mFOLFOX6 |
| 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. |
| Stage 1: Arm A | PLACEBO_COMPARATOR | Participants will receive placebo. |
| Stage 1: Arm B | EXPERIMENTAL | Participants will receive ABBV-181 dose A. |
| Stage 1: Arm C | EXPERIMENTAL | Participants will receive ABBV-181 dose B. |
| Stage 2: Arm D | PLACEBO_COMPARATOR | Participants will receive Placebo. |
| Stage 2: Arm E | EXPERIMENTAL | Participants will receive ABBV-181 dose C. |
| Name | Type | Description |
|---|---|---|
| Budigalimab | DRUG | Intravenous (IV) Infusion |
| Livmoniplimab | DRUG | Intravenous (IV) Infusion |
| Lenvatinib | DRUG | Oral: Capsule |
| Sorafenib | DRUG | Oral: Tablet |
| TTX-030, budigalimab and mFOLFOX6 | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030, budigalimab and docetaxel | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030 and mFOLFOX6 | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030 and budigalimab | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030, budigalimab, nab-paclitaxel and gemcitabine | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030 and pembrolizumab | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030, nab-paclitaxel and gemcitabine | COMBINATION_PRODUCT | Dose and schedule per protocol |
| Budigalimab and mFOLFOX6 | COMBINATION_PRODUCT | Dose and schedule per protocol |
| Placebo | DRUG | Subcutaneous (SC) |
| ABBV-181 | DRUG | Intravenous (IV) Infusion |
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 ...
ABBV-181 is an investigational small molecule being studied for the treatment of Human Immunodeficiency Virus (HIV), specifically HIV-1 infection. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
ABBV-181 targets PD-1, a protein involved in immune regulation. By modulating PD-1, the drug aims to alter immune responses in the context of HIV infection, though its exact therapeutic mechanism in this setting is still under investigation.
ABBV-181 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's safety and effects in people with HIV.
ABBV-181 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. Its safety and efficacy are still being evaluated in early-stage clinical trials.
ABBV-181 has been studied in one completed Phase 1 clinical trial, identified as NCT04223804. This randomized, double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of ABBV-181 in adult participants with HIV-1. The trial enrolled 41 participants across the United States, Australia, Canada, and Puerto Rico.
Yes, ABBV-181 is also known as budigalimab. In clinical trial records, the drug is referred to as ABBV-181 (Budigalimab), indicating that both names refer to the same investigational compound being developed by AbbVie.