Estado del programa
ReclutamientoFase
Fase 2Inmunoterapia previa permitida
NoEnsayo dirigido por el CRC
SíDrogas
ABBV-400, Bevacizumab, fluorouracil, Folinic acid, IrinotecanEtiquetas
MSS/ MMRpComentarios
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
| Ubicación | Situación |
|---|---|
| Estados Unidos | |
|
Mayo Clinic Arizona /ID# 262610 Phoenix, Arizona 85054 |
Reclutamiento |
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Highlands Oncology Group, PA /ID# 259424 Springdale, Arkansas 72762 |
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City of Hope National Medical Center /ID# 257576 Duarte, California 91010 |
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Yale School of Medicine /ID# 257494 New Haven, Connecticut 06519 |
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Mayo Clinic /ID# 262609 Jacksonville, Florida 32224 |
Reclutamiento |
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Northwestern University Robert H. Lurie Comprehensive Cancer Center /ID# 260563 Chicago, Illinois 60611-2927 |
Reclutamiento |
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Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601 Fort Wayne, Indiana 46804 |
Reclutamiento |
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Indiana University Melvin and Bren Simon Cancer Center /ID# 258789 Indianapolis, Indiana 46202-5116 |
Reclutamiento |
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Community Health Network, Inc. /ID# 257078 Indianapolis, Indiana 46250-2042 |
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Comprehensive Cancer Centers of Nevada /ID# 257642 Henderson, Louisiana 89052 |
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Mayo Clinic - Rochester /ID# 257301 Rochester, Minnesota 55905-0001 |
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Levine Cancer Institute /ID# 258840 Charlotte, North Carolina 28204 |
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Duke Cancer Center /ID# 257236 Durham, North Carolina 27710-3000 |
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Medical University of South Carolina /ID# 258486 Charleston, South Carolina 29425 |
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Avera Cancer Institute /ID# 257949 Sioux Falls, South Dakota 57105 |
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MD Anderson Cancer Center /ID# 258713 Houston, Texas 77030 |
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|
Millennium Research and Clinical Development /ID# 257780 Houston, Texas 77090-3063 |
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Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448 Fairfax, Virginia 22031 |
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Virginia Cancer Specialists - Fairfax /ID# 257261 Fairfax, Virginia 22031 |
Reclutamiento |
| Bélgica | |
|
Imelda Ziekenhuis /ID# 257082 Bonheiden, Antwerpen 2820 |
Reclutamiento |
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Universitair Ziekenhuis Antwerpen /ID# 257080 Edegem, Antwerpen 2650 |
Reclutamiento |
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Cliniques Universitaires UCL Saint-Luc /ID# 257081 Woluwe-Saint-Lambert, Bruxelles-Capitale 1200 |
Reclutamiento |
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UZ Gent /ID# 257083 Gent, Oost-Vlaanderen 9000 |
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Universitair Ziekenhuis Leuven /ID# 257079 Leuven, Vlaams-Brabant 3000 |
Reclutamiento |
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AZ-Delta /ID# 257084 Roeselare, West-Vlaanderen 8800 |
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Institut Jules Bordet /ID# 257625 Anderlecht 1070 |
Reclutamiento |
| Alemania | |
|
Universitatsklinikum Mannheim /ID# 257781 Mannheim, Baden-Wuerttemberg 68167 |
Reclutamiento |
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Universitaetsklinikum Tuebingen /ID# 258780 Tübingen, Baden-Wuerttemberg 72076 |
Reclutamiento |
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Universitaetsklinikum Ulm /ID# 257783 Ulm, Baden-Wuerttemberg 89081 |
Reclutamiento |
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Universitaetsklinikum Carl Gustav Carus Dresden /ID# 257787 Dresden, Sachsen 01307 |
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Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 257785 Berlin 13353 |
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Universitaetsklinikum Hamburg-Eppendorf /ID# 257782 Hamburgo 20246 |
Reclutamiento |
| Israel | |
|
Rambam Health Care Campus /ID# 257344 Haifa, H_efa 3109601 |
Reclutamiento |
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Meir Medical Center /ID# 257089 Kfar Saba, HaMerkaz 4428164 |
Reclutamiento |
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The Chaim Sheba Medical Center /ID# 257312 Ramat Gan, Tel-Aviv 5265601 |
Reclutamiento |
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Tel Aviv Sourasky Medical Center /ID# 257090 Tel Aviv, Tel-Aviv 6423906 |
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Shaare Zedek Medical Center /ID# 259253 Jerusalem, Yerushalayim 91031 |
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Hadassah /ID# 257088 Jerusalem, Yerushalayim 91120 |
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Assuta Medical Center /ID# 267581 Tel Aviv 6789140 |
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| Japón | |
|
Aichi Cancer Center Hospital /ID# 257286 Nagoya-shi, Aichi 464-8681 |
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National Cancer Center Hospital East /ID# 257282 Kashiwa-shi, Chiba 277-8577 |
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Kyoto University Hospital /ID# 257287 Kyoto-shi, Kyoto 606-8507 |
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Shizuoka Cancer Center /ID# 257288 Sunto-gun, Shizuoka 411-8777 |
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National Cancer Center Hospital /ID# 257284 Chuo-ku, Tokyo 104-0045 |
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| Corea, República de | |
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Chonnam National University Hwasun Hospital /ID# 258366 Hwasun-gun, Jeonranamdo 58128 |
Reclutamiento |
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Seoul National University Hospital /ID# 257493 Seoul, Seoul Teugbyeolsi 03080 |
Reclutamiento |
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Asan Medical Center /ID# 257845 Seoul, Seoul Teugbyeolsi 05505 |
Reclutamiento |
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Samsung Medical Center /ID# 257571 Seoul, Seoul Teugbyeolsi 06351 |
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Yonsei University Health System Severance Hospital /ID# 257492 Seúl 03722 |
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| España | |
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Hospital Universitario Vall d'Hebron /ID# 257383 Barcelona 08035 |
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Hospital Universitario 12 de Octubre /ID# 257384 Madrid 28041 |
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Hospital Universitario HM Sanchinarro /ID# 258549 Madrid 28050 |
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Hospital Clinico Universitario de Valencia /ID# 257385 Valencia 46010 |
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Hospital Universitario Miguel Servet /ID# 257388 Zaragoza 50009 |
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| Taiwán | |
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Kaohsiung Chang Gung Memorial Hospital /ID# 257675 Kaohsiung City, Kaohsiung 833 |
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National Taiwan University Hospital /ID# 257639 Taipei City, Taipei 100 |
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Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257637 Kaohsiung 807 |
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National Cheng Kung University Hospital /ID# 257638 Tainan 704 |
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Taipei Veterans General Hosp /ID# 257636 Taipei 11217 |
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Linkou Chang Gung Memorial Hospital /ID# 257640 Taoyuan City 333 |
Reclutamiento |
Contactos
Criterios de inclusión
Criterios de inclusión:
* Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Criterios de exclusión
Criterios de exclusión:
* Harbor the BRAF V600E mutation.
* dMMR+/MSI-H.
* Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.
* 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.
