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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Hepatocellular Carcinoma; Esophageal Squamous Cell Carcinoma; Pancreatic Ductal Adenocarcinoma; Triple Negative Breast Cancer; Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer; Head and Neck Squamous-Cell Carcinoma; Biliary Tract Cancers

Treatments: Drug: ABBV-400

Study type: Interventional

Funder types: Industry

Identifiers

NCT06084481

2023-506227-29-00 (Other Identifier)

M24-427

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 7 patient groups

Cohort 1: Hepatocellular Carcinoma (HCC)

Experimental group

Description:

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.

Treatment:

Drug: ABBV-400

Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)

Experimental group

Description:

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.

Treatment:

Drug: ABBV-400

Cohort 3: Biliary Tract Cancers (BTC)

Experimental group

Description:

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.

Treatment:

Drug: ABBV-400

Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)

Experimental group

Description:

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.

Treatment:

Drug: ABBV-400

Cohort 5: Triple Negative Breast Cancer (TNBC)

Experimental group

Description:

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.

Treatment:

Drug: ABBV-400

Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)

Experimental group

Description:

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.

Treatment:

Drug: ABBV-400

Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)

Experimental group

Description:

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.

Treatment:

Drug: ABBV-400