Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084481
• Other study ID #: M24-427
• Secondary ID: 2023-506227-29-0
• Status: Recruiting
• Phase: Phase 1
• Start date: November 9, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 220 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), or advanced solid tumors, will be enrolled in the study in approximately 60 sites worldwide. In the each cohorts, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, and HNSCC 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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), or head and neck squamous-cell-carcinoma (HNSCC) (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 AEs > Grade 1 from prior anticancer therapy except for alopecia.
• History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Biliary Tract Cancers
• Biliary Tract Neoplasms
• Breast Neoplasms
• Carcinoma
• Carcinoma, Hepatocellular
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Hepatocellular Carcinoma
• Pancreatic Ductal Adenocarcinoma
• Squamous Cell Carcinoma of Head and Neck
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• ABBV-400
Intravenous (IV) Infusion

Locations

Country	Name	City	State
Israel	Rabin Medical Center /ID# 256650	Haifa
Israel	Rambam Health Care Campus /ID# 256649	Haifa	H_efa
Israel	Hadassah Medical Center-Hebrew University /ID# 256655	Jerusalem
Israel	The Chaim Sheba Medical Center /ID# 255731	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 258931	Tel Aviv	Tel-Aviv
Japan	National Cancer Center Hospital East /ID# 258934	Kashiwa-shi	Chiba
Japan	The Cancer Institute Hospital Of JFCR /ID# 257788	Koto	Tokyo
Japan	Kyoto University Hospital /ID# 256680	Kyoto-shi	Kyoto
Japan	Aichi Cancer Center Hospital /ID# 256679	Nagoya-shi	Aichi
Japan	NHO Nagoya Medical Center /ID# 261001	Nagoya-shi	Aichi
Japan	Shizuoka Cancer Center /ID# 257789	Sunto-gun	Shizuoka
Puerto Rico	Pan American Center for Oncology Trials /ID# 262903	Rio Piedras
United States	Northwestern University Feinberg School of Medicine /ID# 257378	Chicago	Illinois
United States	Univ Hosp Cleveland /ID# 257706	Cleveland	Ohio
United States	Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926	Denver	Colorado
United States	City of Hope National Medical Center /ID# 258645	Duarte	California
United States	Duke Cancer Center /ID# 255129	Durham	North Carolina
United States	START Midwest /ID# 256581	Grand Rapids	Michigan
United States	Prisma Health /ID# 257697	Greenville	South Carolina
United States	MD Anderson Cancer Center /ID# 255131	Houston	Texas
United States	Tennessee Oncology-Nashville Centennial /ID# 261568	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132	New York	New York
United States	Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693	Providence	Rhode Island
United States	Washington University-School of Medicine /ID# 257379	Saint Louis	Missouri
United States	South Texas Accelerated Research Therapeutics /ID# 260404	San Antonio	Texas
United States	Univ Texas HSC San Antonio /ID# 257708	San Antonio	Texas
United States	Florida Cancer Specialists /ID# 261569	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Israel,  Japan,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	ORR defined as percentage of participants with confirmed best overall response of confirmed partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to 24 Months
Secondary	Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR	DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.	Up to 24 Months
Secondary	Clinical Benefit Rate	CBR is defined as the proportion of participants with a best overall response of stable disease at least 5 weeks post first dose, confirmed CR or PR per investigator review according to RECIST, version 1.1	Up to 24 Months
Secondary	Progression-free Survival (PFS)	PFS is defined as time from first study treatment to a documented disease progression according to RECIST, version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.	Up to 24 Months
Secondary	Overall Survival (OS)	OS is defined as time from first study treatment to death due to any cause.	Up to 24 Months
Secondary	Maximum Observed Concentration (Cmax) of ABBV-400	Cmax of ABBV-400.	Up to 24 Months
Secondary	Time to Cmax (Tmax) of ABBV-400	Tmax of ABBV-400.	Up to 24 Months
Secondary	Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration	AUC for total antibody concentration.	Up to 24 Months
Secondary	Total Antibody Drug Conjugate (ADC) Concentration	Total ADC concentration.	Up to 24 Months
Secondary	Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload	Plasma concentrations of unconjugated Top1 inhibitor payload.	Up to 24 Months
Secondary	Antidrug Antibody (ADA)	Incidence and concentration of anti-drug antibodies.	Up to 24 Months
Secondary	Neutralizing Antidrug Antibody (nADA)	Incidence and concentration of neutralizing anti-drug antibodies.	Up to 24 Months

External Links

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