Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

ABBV-400, Bevacizumab, fluorouracil, Folinic acid, Irinotecan

Tags

MSS/ MMRp

Comments

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

Location Location Status
United States
Highlands Oncology Group, PA /ID# 259424
Springdale, Arkansas 72762
Recruiting
City of Hope National Medical Center /ID# 257576
Duarte, California 91010
Recruiting
Northwestern University Robert H. Lurie Comprehensive Cancer Center /ID# 260563
Chicago, Illinois 60611-2927
Recruiting
Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601
Fort Wayne, Indiana 46804
Recruiting
Community Health Network, Inc. /ID# 257078
Indianapolis, Indiana 46250-2042
Recruiting
Duke Cancer Center /ID# 257236
Durham, North Carolina 27710-3000
Recruiting
Medical University of South Carolina /ID# 258486
Charleston, South Carolina 29425
Recruiting
MD Anderson Cancer Center /ID# 258713
Houston, Texas 77030
Recruiting
Millennium Research and Clinical Development /ID# 257780
Houston, Texas 77090-3063
Recruiting
Virginia Cancer Specialists - Fairfax /ID# 257261
Fairfax, Virginia 22031
Recruiting
Belgium
Imelda Ziekenhuis /ID# 257082
Bonheiden, Antwerpen 2820
Recruiting
AZ-Delta /ID# 257084
Roeselare, West-Vlaanderen 8800
Recruiting
Israel
Tel Aviv Sourasky Medical Center /ID# 257090
Tel Aviv, Tel-Aviv 6423906
Recruiting
Hadassah /ID# 257088
Jerusalem, Yerushalayim 91120
Recruiting
Japan
Aichi Cancer Center Hospital /ID# 257286
Nagoya-shi, Aichi 464-8681
Recruiting
National Cancer Center Hospital East /ID# 257282
Kashiwa-shi, Chiba 277-8577
Recruiting
Kyoto University Hospital /ID# 257287
Kyoto-shi, 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
Korea, Republic of
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 d'Hebron /ID# 257383
Barcelona 08035
Recruiting
Hospital Universitario 12 de Octubre /ID# 257384
Madrid 28041
Recruiting
Hospital Universitario HM Sanchinarro /ID# 258549
Madrid 28050
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 807
Recruiting
National Cheng Kung University Hospital /ID# 257638
Tainan 704
Recruiting
Taipei Veterans General Hosp /ID# 257636
Taipei 11217
Recruiting
Linkou Chang Gung Memorial Hospital /ID# 257640
Taoyuan City 333
Recruiting

Contacts

ABBVIE CALL CENTER
CONTACT
844-663-3742 abbvieclinicaltrials@abbvie.com

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.

Exclusion Criteria

Exclusion Criteria:

* 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.

NCT ID

NCT06107413

Date Trial Added

2023-10-30

Updated Date

2024-12-12