A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Folinic Acid, and Bevacizumab and to Evaluate Safety and Efficacy of ABBV-400 in Combination With Bevacizumab in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer

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Investigational drug late phase More information Active drug More information High burden on patient More information

Trial Details

Sponsor: AbbVie (industry)

Phase: 2

Start date: Nov. 12, 2023

Planned enrollment: 280

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Trial ID: NCT06107413
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More trial details at ClinicalTrials.gov More info

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Goal: To evaluate the safety, efficacy, and optimal dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab, and to compare ABBV-400-containing regimens to standard of care in previously treated patients with unresectable metastatic colorectal cancer.

Patients: Adults with histologically or cytologically confirmed unresectable metastatic colorectal cancer who have measurable disease by RECIST 1.1 and have progressed on only one prior systemic first-line therapy. Patients with BRAF V600E mutations or with dMMR+/MSI-H tumors are excluded, as are those who have recently received prior anticancer therapies.

Design: This is a multicenter, randomized, phase 2 study with approximately 280 participants allocated to several dose-escalation and dose-optimization arms, including comparator standard of care cohorts. ABBV-400 is tested in combination with standard chemotherapeutic agents across multiple dosing schedules.

Treatments: ABBV-400, an investigational antibody-drug conjugate targeting c-Met, is being studied at various doses and schedules in combination with fluorouracil, folinic acid, and bevacizumab. ABBV-400 delivers a novel topoisomerase 1 inhibitor to c-Met expressing cancer cells, disrupting DNA replication. Early phase 1 studies showed objective response rates of 18-24% in colorectal cancer, with better responses (>35%) in tumors with higher c-Met expression, and a manageable safety profile mainly characterized by hematologic and gastrointestinal adverse events. The control arm uses a standard regimen of fluorouracil, folinic acid, bevacizumab, and irinotecan, which is standard second-line therapy for mCRC.

Outcomes: Primary endpoints include objective response rate (ORR) by RECIST v1.1, progression-free survival, and rate of adverse events. Secondary endpoints include duration of response, overall survival, and best overall response as defined by RECIST criteria.

Burden on patient: There is a moderate to high patient burden due to frequent intravenous treatments, regular clinic visits, ongoing laboratory and imaging assessments, and monitoring for adverse events. As this is a dose-finding study with a novel agent, participants can expect more clinic visits and tests than with standard of care, including safety labs, frequent physical exams, and likely additional blood draws for pharmacokinetic and biomarker analyses.

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Universitair Ziekenhuis Antwerpen /ID# 257080

Edegem, Antwerpen, 2650, Belgium

No email / No phone

Status: Recruiting

Imelda Ziekenhuis /ID# 257082

Bonheiden, Antwerpen, 2820, Belgium

No email / No phone

Status: Recruiting

Cliniques Universitaires UCL Saint-Luc /ID# 257081

Bruxelles, Bruxelles-Capitale, 1200, Belgium

No email / No phone

Status: Recruiting

UZ Gent /ID# 257083

Gent, Oost-Vlaanderen, 9000, Belgium

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Status: Recruiting

Universitair Ziekenhuis Leuven /ID# 257079

Leuven, Vlaams-Brabant, 3000, Belgium

No email / No phone

Status: Recruiting

AZ-Delta /ID# 257084

Roeselare, West-Vlaanderen, 8800, Belgium

No email / No phone

Status: Recruiting

Institut Jules Bordet /ID# 257625

Anderlecht, 1070, Belgium

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Status: Recruiting

Universitaetsklinikum Tuebingen /ID# 258780

Tübingen, Baden-Wuerttemberg, 72076, Germany

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Status: Recruiting

Universitaetsklinikum Ulm /ID# 257783

Ulm, Baden-Wuerttemberg, 89081, Germany

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Status: Recruiting

Universitatsklinikum Mannheim /ID# 257781

Mannheim, Baden-Wuerttemberg, 68167, Germany

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Status: Recruiting

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 257787

Dresden, Sachsen, 01307, Germany

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Status: Recruiting

Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 257785

Berlin, 13353, Germany

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Status: Recruiting

Universitaetsklinikum Hamburg-Eppendorf /ID# 257782

Hamburg, 20246, Germany

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Meir Medical Center /ID# 257089

Kfar Saba, HaMerkaz, 4428164, Israel

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Status: Recruiting

Tel Aviv Sourasky Medical Center /ID# 257090

Tel Aviv, Tel-Aviv, 6423906, Israel

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Status: Recruiting

The Chaim Sheba Medical Center /ID# 257312

Ramat Gan, Tel-Aviv, 5265601, Israel

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Status: Recruiting

Hadassah /ID# 257088

Jerusalem, Yerushalayim, 91120, Israel

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Status: Recruiting

Shaare Zedek Medical Center /ID# 259253

Jerusalem, Yerushalayim, 91031, Israel

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Assuta Medical Center /ID# 267581

Tel Aviv, 6789140, Israel

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Rambam Health Care Campus /ID# 257344

Haifa, 3109601, Israel

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Status: Recruiting

Aichi Cancer Center Hospital /ID# 257286

Nagoya-shi, Aichi, 464-8681, Japan

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Status: Recruiting

National Cancer Center Hospital East /ID# 257282

Kashiwa-shi, Chiba, 277-8577, Japan

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Status: Recruiting

Kyoto University Hospital /ID# 257287

Kyoto-shi, Kyoto, 606-8507, Japan

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Status: Recruiting

Shizuoka Cancer Center /ID# 257288

Sunto-gun, Shizuoka, 411-8777, Japan

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Status: Recruiting

National Cancer Center Hospital /ID# 257284

Chuo-ku, Tokyo, 104-0045, Japan

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Status: Recruiting

Chonnam National University Hwasun Hospital /ID# 258366

Hwasun-gun, Jeonranamdo, 58128, Korea, Republic of

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Status: Recruiting

Seoul National University Hospital /ID# 257493

Seoul, Seoul Teugbyeolsi, 03080, Korea, Republic of

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Status: Recruiting

Asan Medical Center /ID# 257845

Seoul, Seoul Teugbyeolsi, 05505, Korea, Republic of

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Status: Recruiting

Samsung Medical Center /ID# 257571

Seoul, Seoul Teugbyeolsi, 06351, Korea, Republic of

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Status: Recruiting

Yonsei University Health System Severance Hospital /ID# 257492

Seoul, 03722, Korea, Republic of

No email / No phone

Status: Recruiting

Hospital Universitario HM Sanchinarro /ID# 258549

Madrid, 28050, Spain

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Status: Recruiting

Hospital Universitario Vall d'Hebron /ID# 257383

Barcelona, 08035, Spain

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Status: Recruiting

Hospital General Universitario Gregorio Maranon /ID# 257387

Madrid, 28007, Spain

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Status: Recruiting

Hospital Universitario 12 de Octubre /ID# 257384

Madrid, 28041, Spain

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Status: Recruiting

Hospital Clinico Universitario de Valencia /ID# 257385

Valencia, 46010, Spain

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Status: Recruiting

Hospital Universitario Miguel Servet /ID# 257388

Zaragoza, 50009, Spain

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Status: Recruiting

Kaohsiung Chang Gung Memorial Hospital /ID# 257675

Kaohsiung City, Kaohsiung, 833, Taiwan

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Status: Recruiting

National Taiwan University Hospital /ID# 257639

Taipei City, Taipei, 100, Taiwan

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Status: Recruiting

Linkou Chang Gung Memorial Hospital /ID# 257640

Taoyuan City, 333, Taiwan

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Status: Recruiting

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257637

Kaohsiung, 807, Taiwan

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Status: Recruiting

National Cheng Kung University Hospital /ID# 257638

Tainan, 704, Taiwan

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Status: Recruiting

Taipei Veterans General Hosp /ID# 257636

Taipei, 11217, Taiwan

No email / No phone

Status: Recruiting

Mayo Clinic Arizona /ID# 262610

Phoenix, Arizona, 85054, United States

No email / No phone

Status: Recruiting

Highlands Oncology Group, PA /ID# 259424

Springdale, Arkansas, 72762, United States

No email / No phone

Status: Completed

City of Hope National Medical Center /ID# 257576

Duarte, California, 91010, United States

No email / No phone

Status: Recruiting

City of Hope Orange County Lennar Foundation Cancer Center /ID# 268365

Irvine, California, 92618, United States

No email / No phone

Status: Recruiting

Yale School of Medicine /ID# 257494

New Haven, Connecticut, 06519, United States

No email / 203-785-3472

Status: Recruiting

Mayo Clinic /ID# 262609

Jacksonville, Florida, 32224, United States

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Status: Recruiting

University of Illinois at Chicago /ID# 257300

Chicago, Illinois, 60607, United States

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Status: Recruiting

Northwestern Memorial Hospital /ID# 260563

Chicago, Illinois, 60611-2927, United States

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Status: Recruiting

Community Health Network, Inc. /ID# 257078

Indianapolis, Indiana, 46250-2042, United States

No email / 317-621-4300

Status: Recruiting

Indiana University Melvin and Bren Simon Cancer Center /ID# 258789

Indianapolis, Indiana, 46202-5116, United States

No email / No phone

Status: Recruiting

Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601

Fort Wayne, Indiana, 46804, United States

No email / No phone

Status: Recruiting

Comprehensive Cancer Centers of Nevada /ID# 257642

Henderson, Louisiana, 89052, United States

No email / No phone

Status: Recruiting

Mayo Clinic - Rochester /ID# 257301

Rochester, Minnesota, 55905-0001, United States

No email / 855-776-0015

Status: Recruiting

Duke Cancer Center /ID# 257236

Durham, North Carolina, 27710-3000, United States

No email / 919-668-1861

Status: Recruiting

Levine Cancer Institute /ID# 258840

Charlotte, North Carolina, 28204, United States

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Status: Recruiting

Oregon Health & Science University, Knight Cancer Institute- /ID# 259190

Portland, Oregon, 97239, United States

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Status: Recruiting

Medical University of South Carolina /ID# 258486

Charleston, South Carolina, 29425, United States

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Status: Recruiting

Avera Cancer Institute /ID# 257949

Sioux Falls, South Dakota, 57105, United States

No email / No phone

Status: Recruiting

Millennium Research and Clinical Development /ID# 257780

Houston, Texas, 77090-3063, United States

No email / 281-440-5006

Status: Recruiting

MD Anderson Cancer Center /ID# 258713

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists - Fairfax /ID# 257261

Fairfax, Virginia, 22031, United States

No email / No phone

Status: Recruiting

Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448

Fairfax, Virginia, 22031, United States

No email / 571-472-4724

Status: Recruiting

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