A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications

Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Cohorts 1-8 receive ABBV-400 alone (monotherapy) followed by a safety follow-up period. Cohort 9 receives ABBV-400 in combination with a strong CYP3A3 inhibitor (ITZ) followed by a safety follow-up period. Approximately 285 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive \[HR+\]/HER2-breast cancer \[BC\]), head and neck squamous-cell-carcinoma (HNSCC), Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer, or advanced solid tumors, will be enrolled in the study in approximately 54 sites worldwide. In cohorts 1-8, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, HNSCC, and PROC/primary peritoneal/fallopian tube cancer will receive intravenous (IV) ABBV-400 monotherapy and in cohort 9 participants will receive intravenous (IV) ABBV-400 and an oral solution of ITZ, for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Laboratory values meeting the criteria laid out in the protocol.

• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

• Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), head and neck squamous-cell-carcinoma (HNSCC), or Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer (by World Health Organization \[WHO\] criteria). Participant meets the criteria for disease activity laid out in the protocol.

Locations
United States
California
City of Hope National Medical Center /ID# 258645
RECRUITING
Duarte
Ucsf /Id# 257705
RECRUITING
San Francisco
Colorado
University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128
COMPLETED
Aurora
Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
RECRUITING
Denver
Florida
Florida Cancer Specialists /ID# 261569
RECRUITING
Sarasota
Illinois
Northwestern University Feinberg School of Medicine /ID# 257378
RECRUITING
Chicago
University of Chicago Medical Center /ID# 258197
RECRUITING
Chicago
Michigan
START Midwest /ID# 256581
RECRUITING
Grand Rapids
Missouri
Washington University-School of Medicine /ID# 257379
RECRUITING
St Louis
North Carolina
Duke Cancer Center /ID# 255129
RECRUITING
Durham
New York
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132
RECRUITING
New York
Ohio
Univ Hosp Cleveland /ID# 257706
RECRUITING
Cleveland
Rhode Island
Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693
RECRUITING
Providence
South Carolina
MUSC Hollings Cancer Center /ID# 257935
RECRUITING
Charleston
Prisma Health /ID# 257697
RECRUITING
Greenville
Tennessee
Tennessee Oncology-Nashville Centennial /ID# 261568
RECRUITING
Nashville
Texas
MD Anderson Cancer Center /ID# 255131
RECRUITING
Houston
South Texas Accelerated Research Therapeutics /ID# 260404
RECRUITING
San Antonio
Univ Texas HSC San Antonio /ID# 257708
RECRUITING
San Antonio
Virginia
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771
RECRUITING
Fairfax
Other Locations
Australia
Chris O'Brien Lifehouse /ID# 262765
RECRUITING
Camperdown
Austin Health /ID# 256635
RECRUITING
Heidelberg
Israel
Rambam Health Care Campus /ID# 256649
RECRUITING
Haifa
Hadassah Medical Center-Hebrew University /ID# 256655
RECRUITING
Jerusalem
Rabin Medical Center /ID# 256650
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center /ID# 255731
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 258931
RECRUITING
Tel Aviv
Japan
National Cancer Center Hospital /ID# 261136
RECRUITING
Chuo-ku
National Cancer Center Hospital East /ID# 258934
RECRUITING
Kashiwa-shi
The Cancer Institute Hospital Of JFCR /ID# 257788
RECRUITING
Koto-ku
Kyoto University Hospital /ID# 256680
RECRUITING
Kyoto
Aichi Cancer Center Hospital /ID# 256679
RECRUITING
Nagoya
NHO Nagoya Medical Center /ID# 261001
RECRUITING
Nagoya
Shizuoka Cancer Center /ID# 257789
RECRUITING
Sunto-gun
Puerto Rico
Pan American Center for Oncology Trials /ID# 262903
RECRUITING
Rio Piedras
Republic of Korea
Inje University Haeundae Paik Hospital /ID# 260118
RECRUITING
Busan
Chungbuk National University Hospital /ID# 256698
RECRUITING
Cheongju-si
Gyeongsang National University Hospital /ID# 260408
COMPLETED
Jinju
Korea University Guro Hospital /ID# 256700
COMPLETED
Seoul
Samsung Medical Center /ID# 258933
RECRUITING
Seoul
Seoul National University Hospital /ID# 255730
RECRUITING
Seoul
Spain
Institut Català d'Oncologia (ICO) - Badalona /ID# 263954
RECRUITING
Badalona
Hospital HM Nou Delfos /ID# 263953
RECRUITING
Barcelona
Clinica Universidad de Navarra - Madrid /ID# 264042
RECRUITING
Madrid
Hospital General Universitario Gregorio Marañón /ID# 262816
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz /ID# 256702
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro /ID# 256701
RECRUITING
Madrid
Hospital Quirón Málaga /ID# 263994
COMPLETED
Málaga
Clinica Universidad de Navarra - Pamplona /ID# 256703
RECRUITING
Pamplona
Hospital Universitario Miguel Servet /ID# 256704
COMPLETED
Zaragoza
Taiwan
E-DA Cancer Hospital /ID# 258880
RECRUITING
Kaohsiung City
China Medical University Hospital /ID# 256712
RECRUITING
Taichung
National Taiwan University Hospital /ID# 256713
RECRUITING
Taipei City
Linkou Chang Gung Memorial Hospital /ID# 259420
COMPLETED
Taoyuan
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2023-11-09
Estimated Completion Date: 2026-07
Participants
Target number of participants: 285
Treatments
Experimental: Cohort 1: Hepatocellular Carcinoma (HCC)
Participants with HCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Experimental: Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)
Participants with PDAC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Experimental: Cohort 3: Biliary Tract Cancers (BTC)
Participants with BTC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Experimental: Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)
Participants with ESCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Experimental: Cohort 5: Triple Negative Breast Cancer (TNBC)
Participants with TNBC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Experimental: Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)
Participants with HR+/HER2-BC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Experimental: Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)
Participants with HNSCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Experimental: Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer
Participants with Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Experimental: Cohort 9: Drug-Drug Interaction
Participants with advanced or metastatic solid tumors will receive ABBV-400 and a strong CYP3A4 inhibitor (ITZ) for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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