Trial Title:
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
NCT ID:
NCT06084481
Condition:
Hepatocellular Carcinoma
Pancreatic Ductal Adenocarcinoma
Biliary Tract Cancers
Esophageal Squamous Cell Carcinoma
Triple Negative Breast Cancer
Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Head and Neck Squamous-Cell Carcinoma
Platinum Resistant High Grade Epithelial Ovarian Cancer
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma, Hepatocellular
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Esophageal Squamous Cell Carcinoma
Biliary Tract Neoplasms
Conditions: Keywords:
Hepatocellular Carcinoma
Pancreatic Ductal Adenocarcinoma
Biliary Tract Cancers
Esophageal Squamous Cell Carcinoma
Triple Negative Breast Cancer
Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Head and Neck Squamous-Cell Carcinoma
Platinum Resistant High Grade Epithelial Ovarian Cancer
Solid Tumors
Advanced Solid Tumors
ABBV-400
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABBV-400
Description:
Intravenous (IV) Infusion
Arm group label:
Cohort 1: Hepatocellular Carcinoma (HCC)
Arm group label:
Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)
Arm group label:
Cohort 3: Biliary Tract Cancers (BTC)
Arm group label:
Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)
Arm group label:
Cohort 5: Triple Negative Breast Cancer (TNBC)
Arm group label:
Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)
Arm group label:
Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)
Arm group label:
Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer
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. Each cohort receives
ABBV-400 alone (monotherapy) followed by a safety follow-up period. Approximately 260
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 the each cohorts, 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 for up to 2 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Have 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.
Palliative radiation therapy for bone, skin, or subcutaneous metastases with 10
fractions or less is permitted and not subject to a washout period.
- Unresolved clinically significant AEs > Grade 1 from prior anticancer therapy.
- History of interstitial lung disease (ILD) or pneumonitis that required treatment
with systemic steroids, or any evidence of active ILD or pneumonitis, including but
not limited to those listed in the protocol.
- History of clinically significant, intercurrent lung-specific illnesses, including
those laid out in the protocol.
- Untreated brain or meningeal metastases (i.e., participants with history of
metastases are eligible provided they do not require ongoing steroid treatment for
cerebral edema and have shown clinical and radiographic stability for at least 14
days after definitive therapy). Participants may continue on antiepileptic therapy
if required.
- History of other active malignancy, with the exception of those laid out in the
protocol.
- Any autoimmune, connective tissue or inflammatory disorders with documented or
suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis,
Sjogren's, sarcoidosis etc.), and prior pneumonectomy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope National Medical Center /ID# 258645
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Ucsf /Id# 257705
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128
Address:
City:
Aurora
Zip:
80045-7158
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists /ID# 261569
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwestern University Feinberg School of Medicine /ID# 257378
Address:
City:
Chicago
Zip:
60611-2927
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago Medical Center /ID# 258197
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
START Midwest /ID# 256581
Address:
City:
Grand Rapids
Zip:
49546-7062
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University-School of Medicine /ID# 257379
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132
Address:
City:
New York
Zip:
10065-6007
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke Cancer Center /ID# 255129
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
Univ Hosp Cleveland /ID# 257706
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693
Address:
City:
Providence
Zip:
02903-4923
Country:
United States
Status:
Recruiting
Facility:
Name:
MUSC Hollings Cancer Center /ID# 257935
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Facility:
Name:
Prisma Health /ID# 257697
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Facility:
Name:
Tennessee Oncology-Nashville Centennial /ID# 261568
Address:
City:
Nashville
Zip:
37203-1632
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center /ID# 255131
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Univ Texas HSC San Antonio /ID# 257708
Address:
City:
San Antonio
Zip:
78229-3901
Country:
United States
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics /ID# 260404
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Chris O'Brien Lifehouse /ID# 262765
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Rambam Health Care Campus /ID# 256649
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
The Chaim Sheba Medical Center /ID# 255731
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Tel Aviv Sourasky Medical Center /ID# 258931
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Facility:
Name:
Rabin Medical Center /ID# 256650
Address:
City:
Haifa
Zip:
4941492
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center-Hebrew University /ID# 256655
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Facility:
Name:
NHO Nagoya Medical Center /ID# 261001
Address:
City:
Nagoya-shi
Zip:
460-0001
Country:
Japan
Status:
Recruiting
Facility:
Name:
Aichi Cancer Center Hospital /ID# 256679
Address:
City:
Nagoya-shi
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East /ID# 258934
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kyoto University Hospital /ID# 256680
Address:
City:
Kyoto-shi
Zip:
606-8507
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center /ID# 257789
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital /ID# 261136
Address:
City:
Chuo-Ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital Of JFCR /ID# 257788
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Inje University Haeundae Paik Hospital /ID# 260118
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Gyeongsang National University Hospital /ID# 260408
Address:
City:
Jinju
Zip:
52727
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital /ID# 255730
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center /ID# 258933
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Korea University Guro Hospital /ID# 256700
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Pan American Center for Oncology Trials /ID# 262903
Address:
City:
Rio Piedras
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Facility:
Name:
Hospital Quirón Málaga /ID# 263994
Address:
City:
Málaga
Zip:
29004
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra - Pamplona /ID# 256703
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital HM Nou Delfos /ID# 263953
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Marañón /ID# 262816
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra - Madrid /ID# 264042
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundación Jiménez Díaz /ID# 256702
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario HM Sanchinarro /ID# 256701
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Miguel Servet /ID# 256704
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Status:
Recruiting
Facility:
Name:
E-DA Cancer Hospital /ID# 258880
Address:
City:
Kaohsiung City
Zip:
82445
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital /ID# 256713
Address:
City:
Taipei City
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
China Medical University Hospital /ID# 256712
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Linkou Chang Gung Memorial Hospital /ID# 259420
Address:
City:
Taoyuan City
Zip:
333
Country:
Taiwan
Status:
Recruiting
Start date:
November 9, 2023
Completion date:
July 1, 2026
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06084481
https://www.abbvieclinicaltrials.com/study/?id=M24-427
