Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-400 · 3 trials · 13 indications
OR is defined as complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, as assessed by the investigator.
PFS is defined as the time from the first dose of study drug to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
ORR defined as percentage of participants with confirmed best overall response of confirmed partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Cmax of ABBV-400 conjugate.
AUCtau of ABBV-400 conjugate.
| Arm | Type | Description |
|---|---|---|
| Stage 1: ABBV-400+FFB A | EXPERIMENTAL | Participants will receive escalating ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB) on dose schedule A as part of the safety lead in, during the 3 year study duration. |
| Stage 1: ABBV-400+FFB B | EXPERIMENTAL | Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration. |
| Stage 2: ABBV-400+FFB A Low | EXPERIMENTAL | Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration. |
| Stage 2: ABBV-400+FFB A High | EXPERIMENTAL | Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration. |
| Stage 2: FFB+Irinotecan (Standard of Care [SOC]) | EXPERIMENTAL | Participants will receive SOC during the 3 year study duration. |
| Stage 3: ABBV-400+FFB B Low | EXPERIMENTAL | Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization/expansion, during the 3 year study duration. |
| Stage 3: ABBV-400+Bevacizumab C High | EXPERIMENTAL | Participants will receive ABBV-400 in combination with Bevacizumab at the high dose determined in the safety lead in on dose schedule C as part of the dose optimization/expansion, during the 3 year study duration. |
| Cohort 1: Hepatocellular Carcinoma (HCC) | EXPERIMENTAL | Participants with HCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. |
| Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC) | EXPERIMENTAL | Participants with PDAC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. |
| Cohort 3: Biliary Tract Cancers (BTC) | EXPERIMENTAL | Participants with BTC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. |
| Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC) | EXPERIMENTAL | Participants with ESCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. |
| Cohort 5: Triple Negative Breast Cancer (TNBC) | EXPERIMENTAL | Participants with TNBC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. |
| Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC) | EXPERIMENTAL | Participants with HR+/HER2-BC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. |
| Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC) | EXPERIMENTAL | Participants with HNSCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. |
| Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer | EXPERIMENTAL | Participants with Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. |
| Cohort 9: Drug-Drug Interaction | EXPERIMENTAL | Participants with advanced or metastatic solid tumors will receive ABBV-400 and a strong CYP3A4 inhibitor (ITZ) for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. |
| Cohort 10: PROC/Primary Peritoneal/Fallopian Tube Cancer | EXPERIMENTAL | Participants with PROC/primary peritoneal/fallopian tube cancer will receive ABBV-400 in combination with bevacizumab for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. |
| Part 1 (Monotherapy Dose Escalation) | EXPERIMENTAL | Participants with advanced solid tumors will receive escalating doses of ABBV-400. |
| Part 2i (wtEGFR Non-Small Cell Lung Cancer [NSCLC]) | EXPERIMENTAL | Participants with non-squamous wtEGFR NSCLC will receive ABBV-400 at the Recommended Phase 2 dose (RP2D). |
| Part 2ii (mutEGFR NSCLC) | EXPERIMENTAL | Participants with non-Squamous mutEGFR NSCLC will receive ABBV-400 at RP2D. |
| Part 2iii (Squamous NSCLC) | EXPERIMENTAL | Participants with squamous NSCLC will receive ABBV-400 at RP2D. |
| Part 3 (Gastroesophageal Adenocarcinoma/Gastroesophagel Junct | EXPERIMENTAL | Participants with gastroesophageal adenocarcinoma will receive ABBV-400 at the RP2D. |
| Part 4 (Colorectal Cancer) | EXPERIMENTAL | Participants with Colorectal Cancer (CRC) will receive ABBV-400 at the RP2D and various dose levels for dose optimization. |
| Part 5 (MET Amplification) | EXPERIMENTAL | Participants with mesenchymal-epithelial transition proto-oncogene (MET) amplification will receive ABBV-400 at the RP2D and various dose levels for dose optimization. |
| Part 6 (MET Mutation) | EXPERIMENTAL | Participants with MET mutation will receive ABBV-400 at the RP2D and various dose levels for dose optimization. |
| Part 7a (Combination Dose Escalation) | EXPERIMENTAL | Participants with CRC will receive escalating doses of ABBV-400 in combination with bevacizumab. |
| Part 7bi (Combination Dose Optimization Low Dose) | EXPERIMENTAL | Participants with CRC will receive the low dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab. |
| Part 7bii (Combination Dose Optimization High Dose) | EXPERIMENTAL | Participants with CRC will receive the high dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab. |
| Part 7biii (Combination Comparator) | EXPERIMENTAL | Participants with CRC will receive trifluridine/tipiracil (TAS-102) in combination with bevacizumab. |
| Name | Type | Description |
|---|---|---|
| ABBV-400 | DRUG | Intravenous (IV) Infusion |
| Bevacizumab | DRUG | IV Infusion |
| Folinic Acid | DRUG | IV Infusion |
| Fluorouracil | DRUG | IV Infusion |
| Irinotecan | DRUG | IV Infusion |
| Itraconazole (ITZ) | DRUG | Oral Solution |
| Trifluridine/Tipiracil | DRUG | Oral Tablet |
Inclusion Criteria: * Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC). * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Progressed on only one first-line (1L) systemic treatment of combination chemotherapy...
ABBV-400 is an investigational small molecule being studied for the treatment of advanced solid tumors, including hepatocellular carcinoma, non-small cell lung cancer, and unresectable metastatic colorectal cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
ABBV-400 targets c-Met, a protein involved in tumor growth and metastasis. By inhibiting this target, the drug aims to interfere with cancer cell signaling pathways. This mechanism is being evaluated in clinical trials for multiple solid tumor indications.
ABBV-400 is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to assess the drug's safety and efficacy in patients with advanced solid tumors.
ABBV-400 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The ongoing trials are designed to evaluate its safety, tolerability, and preliminary efficacy in adult patients with various advanced solid tumors.
ABBV-400 is being studied in several Phase 1 trials, including NCT05029882, which evaluates the drug as monotherapy and in combination with bevacizumab in advanced solid tumors, and NCT06084481, which assesses it in select advanced solid tumor indications. A Phase 2 trial, NCT06107413, is also listed for unresectable metastatic colorectal cancer.
ABBV-400 is an investigational compound with no alternative names listed. It is being studied under this identifier in clinical trials. Patients and healthcare providers should refer to the drug by its formal name, ABBV-400, when discussing clinical trial participation or research findings.