Clinical trial NCT06107413: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Unresectable Metastatic Colorectal Cancer
Keywords: Unresectable Metastatic Colorectal Cancer
ABBV-400
Fluorouracil
Folinic Acid
Bevacizumab
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-10-30
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer.

ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab (FFB) is an approved drug for the treatment of unresectable metastatic colorectal cancer. Study doctors put the participants in groups called treatment arms. Each treatment arm receives a different dose of ABBV-400 in combination with FFB in escalating doses on two different schedules (safety lead in), followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil, folinic acid, irinotecan, and bevacizumab (standard of care \[SOC\]) \[dose optimization\] on its own, ending with low or high doses of ABBV-400 in combination with FFB for continued dose optimization and expansion. Approximately 280 adult participants with unresectable metastatic colorectal cancer will be enrolled in the study in 65 sites worldwide.

In the safety lead in, participants will receive escalating intravenous (IV) ABBV-400 in combination with IV FFB on two different schedules. During the dose optimization participants will receive IV ABBV-400 in combination with IV FFB at low or high doses determined in the safety lead in. The dose optimization arm will also include a comparator cohort in which participants will receive SOC. During the dose optimization and expansion stage, participants will receive IV ABBV-400 in combination with IV FFB at low or high doses that have been determined from the previous stages. The study will run for a duration of approximately 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.


Eligibility 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:

* 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.

Primary outcomes:
measure: Percentage of Participants with Objective Response
timeFrame: Up to 24 Weeks
measure: Progression Free Survival (PFS)
timeFrame: Up to 11 Months
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 3 Years
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to 7 Months
measure: Overall Survival (OS)
timeFrame: Up to 3 Years
measure: Percentage of Participants Achieving Best Overall Response (BOR)
timeFrame: Up to 18 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona /ID# 262610
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group, PA /ID# 259424
state: Arkansas
city: Duarte
country: United States
facility: City of Hope National Medical Center /ID# 257576
state: California
city: Irvine
country: United States
facility: City of Hope Orange County Lennar Foundation Cancer Center /ID# 268365
state: California
city: New Haven
country: United States
facility: Yale School of Medicine /ID# 257494
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic /ID# 262609
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago /ID# 257300
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital /ID# 260563
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center /ID# 258789
state: Indiana
city: Indianapolis
country: United States
facility: Community Health Network, Inc. /ID# 257078
state: Indiana
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada /ID# 257642
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 257301
state: Minnesota
city: Charlotte
country: United States
facility: Levine Cancer Institute /ID# 258840
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Center /ID# 257236
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University, Knight Cancer Institute- /ID# 259190
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 258486
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute /ID# 257949
state: South Dakota
city: Houston
country: United States
facility: MD Anderson Cancer Center /ID# 258713
state: Texas
city: Houston
country: United States
facility: Millennium Research and Clinical Development /ID# 257780
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax /ID# 257261
state: Virginia
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis /ID# 257082
state: Antwerpen
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen /ID# 257080
state: Antwerpen
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 257081
state: Bruxelles-Capitale
city: Gent
country: Belgium
facility: UZ Gent /ID# 257083
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 257079
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ-Delta /ID# 257084
state: West-Vlaanderen
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet /ID# 257625
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim /ID# 257781
state: Baden-Wuerttemberg
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen /ID# 258780
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm /ID# 257783
state: Baden-Wuerttemberg
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden /ID# 257787
state: Sachsen
city: Berlin
country: Germany
facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 257785
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf /ID# 257782
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 257344
state: H_efa
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 257089
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 257312
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 257090
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 259253
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah /ID# 257088
state: Yerushalayim
city: Tel Aviv
country: Israel
facility: Assuta Medical Center /ID# 267581
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 257286
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 257282
state: Chiba
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 257287
state: Kyoto
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center /ID# 257288
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 257284
state: Tokyo
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital /ID# 258366
state: Jeonranamdo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 257493
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 257845
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 257571
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 257492
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 257383
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 257384
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro /ID# 258549
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 257385
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet /ID# 257388
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 257675
state: Kaohsiung
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 257639
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257637
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 257638
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hosp /ID# 257636
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 257640
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: