Clinical trial NCT06084481: Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
Official title: A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: 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
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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-10-16
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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 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.


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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 Months
Secondary outcomes:
measure: Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR
timeFrame: Up to 24 Months
measure: Clinical Benefit Rate
timeFrame: Up to 24 Months
measure: Progression-free Survival (PFS)
timeFrame: Up to 24 Months
measure: Overall Survival (OS)
timeFrame: Up to 24 Months
measure: Maximum Observed Concentration (Cmax) of ABBV-400
timeFrame: Up to 24 Months
measure: Time to Cmax (Tmax) of ABBV-400
timeFrame: Up to 24 Months
measure: Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration
timeFrame: Up to 24 Months
measure: Total Antibody Drug Conjugate (ADC) Concentration
timeFrame: Up to 24 Months
measure: Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload
timeFrame: Up to 24 Months
measure: Antidrug Antibody (ADA)
timeFrame: Up to 24 Months
measure: Neutralizing Antidrug Antibody (nADA)
timeFrame: Up to 24 Months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center /ID# 258645
state: California
city: San Francisco
country: United States
facility: Ucsf /Id# 257705
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128
state: Colorado
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
state: Colorado
city: Sarasota
country: United States
facility: Florida Cancer Specialists /ID# 261569
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 257378
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center /ID# 258197
state: Illinois
city: Grand Rapids
country: United States
facility: START Midwest /ID# 256581
state: Michigan
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 257379
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132
state: New York
city: Durham
country: United States
facility: Duke Cancer Center /ID# 255129
state: North Carolina
city: Cleveland
country: United States
facility: Univ Hosp Cleveland /ID# 257706
state: Ohio
city: Providence
country: United States
facility: Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693
state: Rhode Island
city: Charleston
country: United States
facility: MUSC Hollings Cancer Center /ID# 257935
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health /ID# 257697
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology-Nashville Centennial /ID# 261568
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center /ID# 255131
state: Texas
city: San Antonio
country: United States
facility: Univ Texas HSC San Antonio /ID# 257708
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics /ID# 260404
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771
state: Virginia
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse /ID# 262765
state: New South Wales
city: Heidelberg
country: Australia
facility: Austin Health /ID# 256635
state: Victoria
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 256649
state: H_efa
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 255731
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 258931
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 256655
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 256650
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 261001
state: Aichi
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 256679
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 258934
state: Chiba
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 256680
state: Kyoto
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center /ID# 257789
state: Shizuoka
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital /ID# 261136
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR /ID# 257788
state: Tokyo
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital /ID# 260118
state: Busan Gwang Yeogsi
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital /ID# 256698
state: Chungcheongbugdo
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital /ID# 260408
state: Gyeongsangnamdo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 255730
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 258933
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital /ID# 256700
state: Seoul Teugbyeolsi
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials /ID# 262903
city: Badalona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Badalona /ID# 263954
state: Barcelona
city: Málaga
country: Spain
facility: Hospital Quirón Málaga /ID# 263994
state: Malaga
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona /ID# 256703
state: Navarra
city: Barcelona
country: Spain
facility: Hospital HM Nou Delfos /ID# 263953
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón /ID# 262816
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra - Madrid /ID# 264042
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz /ID# 256702
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro /ID# 256701
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet /ID# 256704
city: Kaohsiung City
country: Taiwan
facility: E-DA Cancer Hospital /ID# 258880
state: Kaohsiung
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 256713
state: Taipei
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 256712
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 259420
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: