telisotuzumab adizutecan (ABBV-400) / AbbVie - LARVOL DELTA

Telisotuzumab adizutecan (ABBV-400; Temab-A) monotherapy vs trifluridine/tipiracil plus bevacizumab in patients with refractory metastatic colorectal cancer with increased c-Met protein expression: An open-label, randomized, phase 3 trial. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT06614192 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • Monotherapy • P3 data • Colorectal Cancer • Oncology • Solid Tumor • MET

Telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with fluorouracil, leucovorin, and budigalimab in locally advanced/metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (a/m GEA). (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06628310 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Combination therapy • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Oncology • Solid Tumor

Phase 1b/2 study evaluating telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with budigalimab in patients (pts) with advanced non-squamous (NSQ) non-small cell lung cancer (NSCLC) with no prior treatment for advanced disease and no actionable genomic alterations. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT06772623 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced EGFR-mutated (MT) non-squamous (NSQ) non-small cell lung cancer (NSCLC): Results from a phase 1 study. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05029882 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P1 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Budigalimab in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations (clinicaltrials.gov) - P1/2 | N=172 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=390 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

Evaluating ABBV-400 with fluorouracil, folinic acid, and bevacizumab in previously treated patients with mCRC (JSMO 2025) - No abstract available

Clinical • Colorectal Cancer • Oncology

ABBV – 400: A c-Met Targeting ADC With Activity in CRC & MET Amplified Tumours (ADC London 2025) - "• Exploring the elusive targeting of c-Met protein • Reviewing the limitations of small molecule inhibitors and antibodies • Discussing next generation ADCs that are effective at targeting the c-Met protein: Teliso-V, Temab-A"

Oncology • MET

Phase 1b study evaluating efficacy and safety of ABBV-400 in select advanced solid tumor indications (JSMO 2025) - No abstract available

Clinical • Metastases • P1 data • Oncology • Solid Tumor

Telisotuzumab Adizutecan (ABBV-400), a c-Met-Targeting ADC, in Pts With Advanced GEA: Results From a Phase 1 Study (JSMO 2025) - No abstract available

Clinical • Metastases • P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MET

ABBV-400, a novel c-Met-targeting antibody-drug conjugate, in advanced solid tumors: Results in colorectal cancer (JSMO 2025) - No abstract available

Metastases • Colorectal Cancer • Oncology • Solid Tumor • MET

M21-404: Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab (clinicaltrials.gov) - P1 | N=520 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=390 | Not yet recruiting | Sponsor: AbbVie

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

Phase 2 randomized study evaluating safety, efficacy, and optimal dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab in previously treated patients with metastatic colorectal cancer. (ASCO-GI 2025) - P2 | "ABBV-400 is a c-Met–directed antibody-drug conjugate composed of the monoclonal antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor payload...In stage 2, patients are randomized to up to 4 ABBV-400 dose cohorts (2 with Q2W and 2 with Q4W ABBV-400 schedule; all in combination with Q2W 5-FU, FA, and bev) and a comparator cohort (irinotecan [180 mg/m2] + 5-FU [400 mg/m2 bolus and 2400 mg/m2 infusion] + FA [200 mg/m2] + bev [5 mg/kg]; all Q2W). Patients are treated until progression, unacceptable toxicity, or other discontinuation criteria are met. Enrollment was initiated in November 2023, with 3 patients enrolled as of January 4, 2024."

Clinical • Combination therapy • Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • EGFR • MET

Genomic alterations in circulating tumor DNA (ctDNA) and response to telisotuzumab adizutecan (ABBV-400) treatment in patients (pts) with colorectal cancer (CRC). (ASCO-GI 2025) - P1 | "Telisotuzumab adizutecan has promising efficacy. RRs were seen in CRC pts with heterogeneous genomic profiles, including pts positive for actionable biomarkers in the metastatic setting. More pts with MR experienced RRs and benefited from treatment."

Circulating tumor DNA • Clinical • Tumor mutational burden • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • ASXL1 • BRAF • FGFR3 • FLT1 • HER-2 • KRAS • MET • NRG1 • PTPRT • SMAD4 • TP53

PK/PD analyses of circulating tumor DNA (ctDNA) in patients with metastatic colorectal cancer (mCRC) treated with telisotuzumab adizutecan (ABBV-400). (ASCO-GI 2025) - P1 | "Exposure-response analyses have previously shown correlation between ABBV-400 conjugate exposures and probability of efficacy (objective response rate) as well as safety in mCRC subjects. The current PK/PD analyses demonstrate that higher ABBV-400 conjugate and payload exposures are also correlated with liquid biopsy data, i.e., ctDNA and MR based on ctDNA. c-MET expression and MET-amp did not have impact on ABBV-400 exposures."

Circulating tumor DNA • Clinical • Metastases • PK/PD data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MET

Biomarkers of response in patients with gastric/gastroesophageal junction adenocarcinoma (GEA) treated with telisotuzumab adizutecan. (ASCO-GI 2025) - P1 | "In pts with advanced GEA treated with telisotuzumab adizutecan, c-Met OE/MET amp and ctDNA-based MR were associated with enhanced antitumor activity. Compared with real-world data, MET amp was enriched in this study population. Phase 2 studies will continue to explore c-Met OE and MET amp prevalence and their potential predictive value with other biomarkers in a clinically representative population."

Biomarker • Clinical • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • MET

A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Budigalimab in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations (clinicaltrials.gov) - P1/2 | N=172 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

AndroMETa-GEA: A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Combination therapy • Enrollment open • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

First-in-human study of ABBV-400, a novel c-Met–targeting antibodydrug conjugate, in advanced solid tumors: Results in colorectal cancer (AIOM 2024) - P1 | "ADC ABBV-400 comprises c-Met–targeting antibody telisotuzumab conjugated to a novel topoisomerase 1 inhibitor payload. ABBV-400 at 2.4 and 3.0mg/kg Q3W has tolerable and manageable safety profile with promising antitumor activity. Long-term tolerability appears improved at 2.4 relative to 3.0mg/kg with higher relative dose intensity and generally lower TEAEs. The study is also evaluating ABBV-400 with bevacizumab in CRC pts."

Metastases • P1 data • Anemia • Colorectal Cancer • Fatigue • Interstitial Lung Disease • Leukopenia • Neutropenia • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • MET

AndroMETa-CRC-: A Randomized Trial Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=460 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Metastases • Monotherapy • Colorectal Cancer • Oncology • Solid Tumor

Genomic alterations in circulating tumor DNA (ctDNA) and response to ABBV-400 treatment in patients with advanced solid tumors (AIOM 2024) - P1 | "The ADC ABBV-400 comprises the c-Met–targeting antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor payload. ABBV-400 showed promising preliminary efficacy, with molecular and radiographic responses in pts with advanced solid tumors with heterogeneous genomic profiles, including pts with high TMB and KRAS mutations."

Circulating tumor DNA • Clinical • Metastases • Tumor mutational burden • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • KRAS • LRP1B • MET • MSI • PTPRT • TMB • TOP1 • TP53

Efficacy of ABBV-400 monotherapy in patients with MET gene amplified advanced solid tumors (AIOM 2024) - P1 | "Background : Anti–c-Met (MET protein) antibody-drug conjugate ABBV-400 comprises monoclonal antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor via a stable, cleavable linker. ABBV-400 monotherapy showed promising tolerability and efficacy in pts with various MET amp advanced solid tumors. Based on these results, MET amp cohort will be expanded to 60 more pts."

Clinical • Metastases • Monotherapy • Anemia • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Hematological Disorders • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Phase 1 results of ABBV-400, a c-Met-targeting ADC, in advanced G/GEJA (YouTube) - "John Strickler, MD...discusses findings from a Phase I study (NCT05029882) of ABBV-400, a c-Met–targeting antibody-drug conjugate (ADC) for advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA). ABBV-400 had some promising antitumor activity and a manageable safety profile, and common treatment-emergent adverse events (TEAEs) included anemia, nausea, and thrombocytopenia."

Interview • Video

Study to Assess Adverse Events and How Intravenously (IV) Infused ABBV-400 Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=27 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor