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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06084481




Registration number
NCT06084481
Ethics application status
Date submitted
10/10/2023
Date registered
16/10/2023

Titles & IDs
Public 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
Scientific title
A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
Secondary ID [1] 0 0
2023-506227-29-00
Secondary ID [2] 0 0
M24-427
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Pancreatic Ductal Adenocarcinoma 0 0
Biliary Tract Cancers 0 0
Esophageal Squamous Cell Carcinoma 0 0
Triple Negative Breast Cancer 0 0
Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer 0 0
Head and Neck Squamous-Cell Carcinoma 0 0
Platinum Resistant High Grade Epithelial Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Liver
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Oesophageal (gullet)
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-400

Experimental: Cohort 1: Hepatocellular Carcinoma (HCC) - Participants with HCC will receive ABBV-400 for up to 2 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 2 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 2 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 2 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 2 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 2 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 2 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 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.


Treatment: Drugs: ABBV-400
Intravenous (IV) Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 24 Months
Secondary outcome [1] 0 0
Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR
Timepoint [1] 0 0
Up to 24 Months
Secondary outcome [2] 0 0
Clinical Benefit Rate
Timepoint [2] 0 0
Up to 24 Months
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Timepoint [3] 0 0
Up to 24 Months
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to 24 Months
Secondary outcome [5] 0 0
Maximum Observed Concentration (Cmax) of ABBV-400
Timepoint [5] 0 0
Up to 24 Months
Secondary outcome [6] 0 0
Time to Cmax (Tmax) of ABBV-400
Timepoint [6] 0 0
Up to 24 Months
Secondary outcome [7] 0 0
Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration
Timepoint [7] 0 0
Up to 24 Months
Secondary outcome [8] 0 0
Total Antibody Drug Conjugate (ADC) Concentration
Timepoint [8] 0 0
Up to 24 Months
Secondary outcome [9] 0 0
Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload
Timepoint [9] 0 0
Up to 24 Months
Secondary outcome [10] 0 0
Antidrug Antibody (ADA)
Timepoint [10] 0 0
Up to 24 Months
Secondary outcome [11] 0 0
Neutralizing Antidrug Antibody (nADA)
Timepoint [11] 0 0
Up to 24 Months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse /ID# 262765 - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Rhode Island
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Israel
State/province [15] 0 0
H_efa
Country [16] 0 0
Israel
State/province [16] 0 0
Tel-Aviv
Country [17] 0 0
Israel
State/province [17] 0 0
Haifa
Country [18] 0 0
Israel
State/province [18] 0 0
Jerusalem
Country [19] 0 0
Japan
State/province [19] 0 0
Aichi
Country [20] 0 0
Japan
State/province [20] 0 0
Chiba
Country [21] 0 0
Japan
State/province [21] 0 0
Kyoto
Country [22] 0 0
Japan
State/province [22] 0 0
Shizuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Tokyo
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Busan Gwang Yeogsi
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Chungcheongbugdo
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Gyeongsangnamdo
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul Teugbyeolsi
Country [28] 0 0
Puerto Rico
State/province [28] 0 0
Rio Piedras
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Malaga
Country [31] 0 0
Spain
State/province [31] 0 0
Navarra
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid
Country [33] 0 0
Spain
State/province [33] 0 0
Zaragoza
Country [34] 0 0
Taiwan
State/province [34] 0 0
Kaohsiung
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taipei
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taichung
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taoyuan City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06084481