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

May 2, 2024 updated by: AbbVie

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel, 4941492
        • Recruiting
        • Rabin Medical Center /ID# 256650
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Center-Hebrew University /ID# 256655
    • H_efa
      • Haifa, H_efa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus /ID# 256649
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5265601
        • Recruiting
        • The Chaim Sheba Medical Center /ID# 255731
      • Tel Aviv, Tel-Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center /ID# 258931
  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 460-0001
        • Recruiting
        • NHO Nagoya Medical Center /ID# 261001
      • Nagoya-shi, Aichi, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital /ID# 256679
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East /ID# 258934
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital /ID# 256680
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center /ID# 257789
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital Of JFCR /ID# 257788
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials /ID# 262903
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center /ID# 258645
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists /ID# 261569
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Recruiting
        • Northwestern University Feinberg School of Medicine /ID# 257378
    • Michigan
      • Grand Rapids, Michigan, United States, 49546-7062
        • Recruiting
        • START Midwest /ID# 256581
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University-School of Medicine /ID# 257379
    • New York
      • New York, New York, United States, 10065-6007
        • Recruiting
        • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center /ID# 255129
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Univ Hosp Cleveland /ID# 257706
    • Rhode Island
      • Providence, Rhode Island, United States, 02903-4923
        • Recruiting
        • Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health /ID# 257697
    • Tennessee
      • Nashville, Tennessee, United States, 37203-1632
        • Recruiting
        • Tennessee Oncology-Nashville Centennial /ID# 261568
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center /ID# 255131
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics /ID# 260404
      • San Antonio, Texas, United States, 78229-3901
        • Recruiting
        • Univ Texas HSC San Antonio /ID# 257708

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: ABBV-400
Intravenous (IV) Infusion
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.
Drug: ABBV-400
Intravenous (IV) Infusion
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.
Drug: ABBV-400
Intravenous (IV) Infusion
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.
Drug: ABBV-400
Intravenous (IV) Infusion
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.
Drug: ABBV-400
Intravenous (IV) Infusion
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.
Drug: ABBV-400
Intravenous (IV) Infusion
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.
Drug: ABBV-400
Intravenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 24 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR
Time Frame: Up to 24 Months
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
Clinical Benefit Rate
Time Frame: Up to 24 Months
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
Progression-free Survival (PFS)
Time Frame: Up to 24 Months
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
Overall Survival (OS)
Time Frame: Up to 24 Months
OS is defined as time from first study treatment to death due to any cause.
Up to 24 Months
Maximum Observed Concentration (Cmax) of ABBV-400
Time Frame: Up to 24 Months
Cmax of ABBV-400.
Up to 24 Months
Time to Cmax (Tmax) of ABBV-400
Time Frame: Up to 24 Months
Tmax of ABBV-400.
Up to 24 Months
Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration
Time Frame: Up to 24 Months
AUC for total antibody concentration.
Up to 24 Months
Total Antibody Drug Conjugate (ADC) Concentration
Time Frame: Up to 24 Months
Total ADC concentration.
Up to 24 Months
Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload
Time Frame: Up to 24 Months
Plasma concentrations of unconjugated Top1 inhibitor payload.
Up to 24 Months
Antidrug Antibody (ADA)
Time Frame: Up to 24 Months
Incidence and concentration of anti-drug antibodies.
Up to 24 Months
Neutralizing Antidrug Antibody (nADA)
Time Frame: Up to 24 Months
Incidence and concentration of neutralizing anti-drug antibodies.
Up to 24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M24-427
  • 2023-506227-29-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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