Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Telisotuzumab Adizutecan
ABBV-400 · 17 trials · 25 indications
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or partial response (PR) per BICR based on RECIST version 1.1.
OS is defined as the time from date of randomization to the event of death from any cause.
Best overall response of confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
OS is defined as the time from date of randomization to the event of death from any cause.
An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1.
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.
OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1.
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per the BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the BICR or death from any cause, whichever occurs earlier.
OR is defined as (subjects achieving complete response \[CR\] or partial response \[PR\]) as assessed by ICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (criteria) (RANO) 2.0 criteria as appropriate to tumor type in participants with MET amplified positivity determined by FoundationOne CDx (F1CDx) testing.
DFS is defined as the time from randomization to the time of first occurrence of first radiographic recurrence of colorectal cancer (CRC), (either local recurrence or distant metastases) as determined by the investigator, or death from any cause.
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) per BICR based on RECIST version 1.1.
PFS is defined as the time from the participant's randomization date to the first occurrence of radiographic progression per BICR based on RECIST version 1.1 or death from any cause, whichever occurs earlier.
OR is defined as confirmed CR or PR as assessed by the investigator per RECIST, version 1.1.
PFS is defined as the time from the first dose of study drug to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by investigator or death from any cause, whichever occurs earlier.
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator per RECIST version 1.1.
An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational drug.
Vital signs are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation (SpO2), and body temperature will be obtained at visits.
Percentage of participants with clinically significant ECGs findings as assessed by the investigator.
Percentage of participants with clinically significant laboratory values (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
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.
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) per BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
DLTs are defined as grade \>= 3 thrombocytopenia that cannot clinically improve after adequate medical treatment/support, febrile neutropenia grade \>= 3 or grade 4 neutropenia that cannot clinically improve after adequate medical treatment/support, and any grade 2 or higher interstitial lung disease (ILD)/pneumonitis that cannot clinically improve after adequate medical treatment/support.
Cmax of telisotuzumab adizutecan conjugate.
Tmax of telisotuzumab adizutecan conjugate.
AUC of telisotuzumab adizutecan conjugate.
Total antibody of telisotuzumab adizutecan.
Unconjugated payload of telisotuzumab adizutecan.
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 |
|---|---|---|
| Telisotuzumab Adizutecan | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan until meeting study drug discontinuation criteria. |
| Standard of care (SOC) | ACTIVE_COMPARATOR | Participants will receive SOC docetaxel or docetaxel plus ramucirumab until meeting study drug discontinuation criteria. |
| Ph 3: Telisotuzumab Adizutecan + Bevacizumab | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration. |
| Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab | EXPERIMENTAL | Participants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration. |
| Telisotuzumab Adizutecan Dose A + Pembrolizumab | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 67 weeks study duration. |
| Telisotuzumab Adizutecan Dose B + Pembrolizumab | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan at Dose B with pembrolizumab, as part of the 67 weeks study duration. |
| Pembrolizumab + Platinum Chemotherapy + Fluorouracil | ACTIVE_COMPARATOR | Participants will receive pembrolizumab with standard of care (SOC) platinum chemotherapy (investigator's choice of carboplatin or cisplatin) and fluorouracil (5-FU), as part of the 67 weeks study duration. |
| SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan + Gemcitabine until doses for optimization are determined. as part of an approximately 3 year study period. |
| SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan Dose A + Gemcitabine as part of the approximately 3 year study duration. |
| SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan Dose B + Gemcitabine as part of the approximately 3 year study duration. |
| SS1: Dose Optimization: Standard of Care (SOC) | ACTIVE_COMPARATOR | Participants will receive gemcitabine and nab-paclitaxel as part of the approximately 3 year study duration. |
| Ph 2: Dose Escalation Telisotuzumab Adizutecan + FOLFOX | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan + fluorouracil, folinic acid, and oxaliplatin (FOLFOX) until doses for optimization are determined, as part of an approximately 2 year study period. |
| Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose A | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose A as part of the approximately 2 year study duration. |
| Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose B | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose B as part of the approximately 2 year study duration. |
| Ph 2: Dose Optimization Standard of Care (SOC) mFOLFIRINOX | ACTIVE_COMPARATOR | Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration. |
| Ph 3: Telisotuzumab Adizutecan RP3D + FOLFOX | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan recommended Phase 3 dose (RP3D) + FOLFOX as part of an approximately 2 year study period. |
| Ph 3: SOC mFOLFIRINOX | ACTIVE_COMPARATOR | Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration. |
| Phase 2: Telisotuzumab Adizutecan Dose A | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration. |
| Phase 2: Telisotuzumab Adizutecan Dose B | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration. |
| Phase 2: Telisotuzumab Adizutecan Dose A + Osimertinib | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A in combination with osimertinib, as part of the approximately 69 month study duration. |
| Phase 2: Telisotuzumab Adizutecan Dose B + Osimertinib | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose B in combination with osimertinib, as part of the approximately 69 month study duration. |
| Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration. |
| Phase 3: Stand of Care (SOC) | EXPERIMENTAL | Participants will receive investigator's choice of SOC, as part of the approximately 69 month study duration. |
| Telisotuzumab Adizutecan Monotherapy | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration. |
| Stage 1: Escalation Telisotuzumab Adizutecan + Osimertinib | EXPERIMENTAL | Participants will receive increasing doses of telisotuzumab adizutecan with osimertinib (Osi), as part of the approximately 76 month study duration. |
| Stage 1: Expansion Telisotuzumab Adizutecan Dose A + Osi | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A with Osi, as part of the approximately 76 month study duration. |
| Stage 1: Expansion Telisotuzumab Adizutecan Dose B + Osi | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose B with Osi, as part of the approximately 76 month study duration. |
| Stage 1: Expansion Telisotuzumab Adizutecan Dose C + Osi | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose C with Osi, as part of the approximately 76 month study duration. |
| Stage 1: Expansion Osi + Chemotherapy + Pemetrexed | EXPERIMENTAL | Participants will receive Osi with chemotherapy followed by Osi with pemetrexed, as part of the approximately 76 month study duration. |
| Stage 2: Standared of Care (SOC) | EXPERIMENTAL | Participants will receive SOC, as part of the approximately 76 month study duration. |
| Stage 2: Optimized Telisotuzumab Adizutecan + Osi | EXPERIMENTAL | Participants will receive the optimized dose of telisotuzumab adizutecan with Osi, as part of the approximately 76 month study duration. |
| Substudy 1: Dose Escalation Telisotuzumab Adizutecan | EXPERIMENTAL | Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) and bevacizumab as part of the approximately 6 year study duration. |
| Substudy 1: Dose Expansion Telisotuzumab Adizutecan High Dose | EXPERIMENTAL | Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration. |
| Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low Dose | EXPERIMENTAL | Participants will receive the low dose of telisotuzumab adizutecandetermined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration. |
| Substudy 1: Dose Expansion Compatator | EXPERIMENTAL | Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration. |
| Substudy 2: Dose Escalation Telisotuzumab Adizutecan | EXPERIMENTAL | Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil (5-FU) and leucovorin (LV) and panitumumab as part of the approximately 6 year study duration. |
| Substudy 2: Dose Expansion Telisotuzumab Adizutecan High Dose | EXPERIMENTAL | Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration. |
| Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low Dose | EXPERIMENTAL | Participants will receive the low dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration. |
| Substudy 2: Dose Expansion Compatator | EXPERIMENTAL | Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration. |
| Stage 1: Dose Escalation ABBV-400 | EXPERIMENTAL | Participants will receive escalating doses of telisotuzumab adizutecan (ABBV-400) in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration. |
| Stage 2 Arm 1: Dose Optimization ABBV-400 Dose A | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan (ABBV-400) dose A in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration. |
| Stage 2 Arm 2: Dose Optimization ABBV-400 Dose B | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan (ABBV-400) dose B in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration. |
| Stage 2 Arm 3: Dose Optimization Standard of Care (SOC) | EXPERIMENTAL | Participants will receive a fixed dose of leucovorin (folinic acid), fluorouracil, oxaliplatin (FOLFOX) and budigalimab as part of the approximately 6 year study duration. |
| Telisotuzumab Adizutecan Dose A | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 4 year study duration. |
| Telisotuzumab Adizutecan Dose B | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 4 year study duration. |
| 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. |
| Part 1: Telisotuzumab Adizutecan + Budigalimab | EXPERIMENTAL | Participants will receive several doses of telisotuzumab adizutecan in combination with budigalimab, as part of the 33 month study duration. |
| Part 2 Arm 1: Telisotuzumab Adizutecan + Pembrolizumab | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A in combination with pembrolizumab, as part of the 33 month study duration. |
| Part 2 Arm 2: Telisotuzumab Adizutecan + Pembrolizumab | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose B in combination with pembrolizumab, as part of the 33 month study duration. |
| Part 2: Standard of Care | EXPERIMENTAL | Participants will receive pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed, as part of the 33 month study duration. |
| Safety Run-In Cohort 1: Telisotuzumab Adizutecan Dose A | EXPERIMENTAL | Participants with unresectable locally advanced/metastatic colorectal cancer (CRC) will receive telisotuzumab adizutecan dose A during the approximately 2.5 year study duration. |
| Safety Run-In Cohort 2: Telisotuzumab Adizutecan Dose B | EXPERIMENTAL | Participants with unresectable locally advanced/metastatic CRC will receive telisotuzumab adizutecan dose B during the approximately 2.5 year study duration. |
| Dose Expansion Part 1: Telisotuzumab Adizutecan Dose A | EXPERIMENTAL | Participants with unresectable locally advanced/metastatic CRC will receive telisotuzumab adizutecan dose A during the approximately 2.5 year study duration. |
| Dose Expansion Part 2: Telisotuzumab Adizutecan Dose C | EXPERIMENTAL | If further analysis is warranted, participants with unresectable locally advanced/metastatic CRC will receive telisotuzumab adizutecan dose C during the approximately 2.5 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 |
|---|---|---|
| Telisotuzumab Adizutecan | DRUG | Intravenous (IV) |
| Docetaxel | DRUG | IV |
| Ramucirumab | DRUG | IV |
| Bevacizumab | DRUG | Intravenous (IV) |
| Trifluridine/Tipiracil | DRUG | Oral |
| Pembrolizumab | DRUG | IV |
| Carboplatin | DRUG | IV |
| Cisplatin | DRUG | IV |
| Fluorouracil | DRUG | IV |
| Gemcitabine | DRUG | Intravenous (IV) Infusion |
| Nab-Paclitaxel | DRUG | Intravenous (IV) Infusion |
| Folinic acid/ Leucovorina | DRUG | IV Infusion |
| Oxaliplatin | DRUG | IV Infusion |
| Irinotecan | DRUG | IV Infusion |
| Standard of Care | DRUG | Standard of Care |
| Osimertinib | DRUG | Oral |
| Osimertinib (Osi) | DRUG | Oral |
| Pemetrexed | DRUG | IV |
| Leucovorin | DRUG | IV Infusion; IV Injection |
| Panitumumab | DRUG | IV Infusion |
| Budigalimab | DRUG | IV Infusion |
| ABBV-400 | DRUG | Intravenous (IV) Infusion |
| Folinic Acid | DRUG | IV Infusion |
| Itraconazole (ITZ) | DRUG | Oral Solution |
Inclusion Criteria: * Histologically or cytologically confirmed metastatic/locally advanced non-squamous NSCLC * Known EGFR activating mutation status (EGFR wildtype only; participants with EGFR activating mutations are not eligible) * Cellular-mesenchymal epithelial transition (c-Met) Immunohistoc...
ABBV-400 is an investigational oncology drug being studied in adults with advanced solid tumors, including hepatocellular carcinoma, non-small cell lung cancer, and unresectable metastatic colorectal cancer. It is also being evaluated in pancreatic ductal adenocarcinoma, biliary tract cancers, esophageal squamous cell carcinoma, triple negative breast cancer, and other advanced tumor types.
ABBV-400 targets c-Met, a protein that is a receptor tyrosine kinase. By binding c-Met, the drug is designed to act on tumor cells that express this target. The clinical program is biomarker selected, meaning participants are chosen based on characteristics related to the target.
ABBV-400 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical studies evaluating the drug in advanced solid tumors.
ABBV-400 is in Phase 1 and Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 studies are evaluating the drug as monotherapy and in combination, while a Phase 2 study is testing it in unresectable metastatic colorectal cancer.
ABBV-400 is being studied in NCT05029882, a Phase 1 trial in advanced solid tumors including non-small cell lung cancer and colorectal cancer, and NCT06084481, a Phase 1 trial in select advanced solid tumors. NCT06107413 is a Phase 2 trial in unresectable metastatic colorectal cancer combining ABBV-400 with fluorouracil, folinic acid, and bevacizumab.
The ABBV-400 clinical program has a total planned enrollment of about 1,125 participants across three studies. NCT05029882 plans to enroll 520 participants, NCT06084481 plans 325, and NCT06107413 plans 280. All trials enroll adults aged 18 years and older.