Program Status
RecruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
ABBV-400, Bevacizumab, fluorouracil, Folinic acid, IrinotecanTags
MSS/ MMRpComments
Phase II trial for patients with metastatic CRC who progressed on only one first-line systemic treatment (trial to consider before starting 2nd line treatment for the metastatic setting).
Only for MSS patients, no BRAF mutation allowed.
Combination of a novel agent at different doses, with different combinations of standard of care treatment.
ABBV-400: ADC (antibody-drug conjugate). C -Met–targeting antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor (Top1i) payload.
Standard of care drugs used in combinations in this trial: Fluorouracil, Folinic Acid, Bevacizumab
Helpful Links
https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.3015 PK/PD analyses of circulating tumor DNA (ctDNA) in patients with metastatic colorectal cancer (mCRC) treated with telisotuzumab adizutecan (ABBV-400). Genomic alterations in circulating tumor DNA (ctDNA) and response to telisotuzumab adizutecan (ABBV-400) treatment in patients (pts) with colorectal cancer (CRC). First-in-human study of ABBV-400, a novel c-Met–targeting antibody-drug conjugate, in advanced solid tumors: Results in colorectal cancer. Abstract 6311: ABBV-400: An ADC delivering a novel topoisomerase 1 inhibitor to c-Met-positive solid tumors| Location | Location Status |
|---|---|
| United States | |
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Mayo Clinic Arizona /ID# 262610 Phoenix, Arizona 85054 |
Recruiting |
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Highlands Oncology Group, PA /ID# 259424 Springdale, Arkansas 72762 |
Completed |
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City of Hope National Medical Center /ID# 257576 Duarte, California 91010 |
Recruiting |
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City of Hope - Orange County Lennar Foundation Cancer Center /ID# 268365 Irvine, California 92618 |
Recruiting |
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Yale School of Medicine /ID# 257494 New Haven, Connecticut 06519 |
Recruiting |
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Mayo Clinic Hospital Jacksonville /ID# 262609 Jacksonville, Florida 32224 |
Recruiting |
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University of Illinois Hospital and Health Sciences System /ID# 257300 Chicago, Illinois 60607 |
Recruiting |
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Northwestern Medicine - Northwestern Memorial Hospital /ID# 260563 Chicago, Illinois 60611 |
Recruiting |
|
Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601 Fort Wayne, Indiana 46804 |
Recruiting |
|
Indiana University Melvin and Bren Simon Cancer Center /ID# 258789 Indianapolis, Indiana 46202-5116 |
Recruiting |
|
Community Health Network, Inc. /ID# 257078 Indianapolis, Indiana 46250-2042 |
Recruiting |
|
Comprehensive Cancer Centers of Nevada /ID# 257642 Henderson, Louisiana 89052 |
Recruiting |
|
Mayo Clinic - Rochester /ID# 257301 Rochester, Minnesota 55905-0001 |
Recruiting |
|
Levine Cancer Institute /ID# 258840 Charlotte, North Carolina 28204 |
Recruiting |
|
Duke Cancer Center /ID# 257236 Durham, North Carolina 27710-3000 |
Recruiting |
|
Oregon Health & Science University, Knight Cancer Institute- /ID# 259190 Portland, Oregon 97239 |
Recruiting |
|
Medical University of South Carolina /ID# 258486 Charleston, South Carolina 29425 |
Recruiting |
|
Avera Cancer Institute /ID# 257949 Sioux Falls, South Dakota 57105 |
Recruiting |
|
MD Anderson Cancer Center /ID# 258713 Houston, Texas 77030 |
Recruiting |
|
Texas Oncology PA /ID# 257780 Houston, Texas 77090-3063 |
Recruiting |
|
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448 Fairfax, Virginia 22031 |
Recruiting |
|
Virginia Cancer Specialists - Fairfax /ID# 257261 Fairfax, Virginia 22031 |
Recruiting |
| Belgium | |
|
Imelda Ziekenhuis /ID# 257082 Bonheiden, Antwerpen 2820 |
Recruiting |
|
Universitair Ziekenhuis Antwerpen /ID# 257080 Edegem, Antwerpen 2650 |
Recruiting |
|
Cliniques Universitaires UCL Saint-Luc /ID# 257081 Brussels, Brussels Capital 1200 |
Recruiting |
|
UZ Gent /ID# 257083 Ghent, Oost-Vlaanderen 9000 |
Recruiting |
|
Universitair Ziekenhuis Leuven /ID# 257079 Leuven, Vlaams-Brabant 3000 |
Recruiting |
|
AZ-Delta /ID# 257084 Roeselare, West-Vlaanderen 8800 |
Recruiting |
|
Institut Jules Bordet /ID# 257625 Anderlecht 1070 |
Recruiting |
| Germany | |
|
Universitatsklinikum Mannheim /ID# 257781 Mannheim, Baden-Wurttemberg 68167 |
Recruiting |
|
Universitaetsklinikum Tuebingen /ID# 258780 Tübingen, Baden-Wurttemberg 72076 |
Recruiting |
|
Universitaetsklinikum Ulm /ID# 257783 Ulm, Baden-Wurttemberg 89081 |
Recruiting |
|
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 257787 Dresden, Saxony 01307 |
Recruiting |
|
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 257785 Berlin 13353 |
Recruiting |
|
Universitaetsklinikum Hamburg-Eppendorf /ID# 257782 Hamburg 20246 |
Recruiting |
| Israel | |
|
Meir Medical Center /ID# 257089 Kfar Saba, Central District 4428164 |
Recruiting |
|
Shaare Zedek Medical Center /ID# 259253 Jerusalem, Jerusalem 91031 |
Recruiting |
|
Hadassah /ID# 257088 Jerusalem, Jerusalem 91120 |
Recruiting |
|
The Chaim Sheba Medical Center /ID# 257312 Ramat Gan, Tel Aviv 5265601 |
Recruiting |
|
Tel Aviv Sourasky Medical Center /ID# 257090 Tel Aviv, Tel Aviv 6423906 |
Recruiting |
|
Rambam Health Care Campus /ID# 257344 Haifa 3109601 |
Recruiting |
|
Assuta Medical Center /ID# 267581 Tel Aviv 6789140 |
Recruiting |
| Japan | |
|
Aichi Cancer Center Hospital /ID# 257286 Nagoya, Aichi-ken 464-8681 |
Recruiting |
|
National Cancer Center Hospital East /ID# 257282 Kashiwa-shi, Chiba 277-8577 |
Recruiting |
|
Kyoto University Hospital /ID# 257287 Kyoto, Kyoto 606-8507 |
Recruiting |
|
Shizuoka Cancer Center /ID# 257288 Sunto-gun, Shizuoka 411-8777 |
Recruiting |
|
National Cancer Center Hospital /ID# 257284 Chuo-ku, Tokyo 104-0045 |
Recruiting |
| South Korea | |
|
Chonnam National University Hwasun Hospital /ID# 258366 Hwasun-gun, Jeonranamdo 58128 |
Recruiting |
|
Seoul National University Hospital /ID# 257493 Seoul, Seoul Teugbyeolsi 03080 |
Recruiting |
|
Asan Medical Center /ID# 257845 Seoul, Seoul Teugbyeolsi 05505 |
Recruiting |
|
Samsung Medical Center /ID# 257571 Seoul, Seoul Teugbyeolsi 06351 |
Recruiting |
|
Yonsei University Health System Severance Hospital /ID# 257492 Seoul 03722 |
Recruiting |
| Spain | |
|
Hospital Universitario Vall de Hebron /ID# 257383 Barcelona 08035 |
Recruiting |
|
Hospital General Universitario Gregorio Maranon /ID# 257387 Madrid 28007 |
Recruiting |
|
Hospital Universitario 12 de Octubre /ID# 257384 Madrid 28041 |
Recruiting |
|
Hospital Universitario HM Sanchinarro /ID# 258549 Madrid 28050 |
Recruiting |
|
Hospital Clinico Universitario de Valencia /ID# 257385 Valencia 46010 |
Recruiting |
|
Hospital Universitario Miguel Servet /ID# 257388 Zaragoza 50009 |
Recruiting |
| Taiwan | |
|
Kaohsiung Chang Gung Memorial Hospital /ID# 257675 Kaohsiung City, Kaohsiung 833 |
Recruiting |
|
National Taiwan University Hospital /ID# 257639 Taipei City, Taipei 100 |
Recruiting |
|
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257637 Kaohsiung City 807 |
Recruiting |
|
National Cheng Kung University Hospital /ID# 257638 Tainan City 704 |
Recruiting |
|
Taipei Veterans General Hosp /ID# 257636 Taipei 11217 |
Recruiting |
|
Linkou Chang Gung Memorial Hospital /ID# 257640 Taoyuan 333 |
Recruiting |
Contacts
Inclusion Criteria
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 in the metastatic setting with or without targeted therapy.
Exclusion Criteria
Exclusion Criteria:
* Harbor the BRAF V600E mutation.
* dMMR+/MSI-H.
* Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400.
