What side effects are associated with this type of intervention?

Common treatments for esophageal cancer, such as chemoradiotherapy and immunotherapy, often come with significant side effects. Chemoradiotherapy can cause severe esophagitis, hematologic toxicities (like neutropenia and anemia), and pulmonary toxicities. Immunotherapy, including PD-1 inhibitors like pembrolizumab, may lead to immune-related adverse events such as fatigue, rash, and colitis. Investigational drugs like ABBV-400, while still under study, may have similar side effects to other targeted therapies, including gastrointestinal disturbances, fatigue, and hematologic toxicities. Patients should discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for esophageal cancer, particularly focusing on targeted therapies and immunotherapies. Pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved for use in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have tumors expressing PD-L1. Another notable approval is for nivolumab, another PD-1 inhibitor, which is used for patients with unresectable advanced, recurrent, or metastatic esophageal cancer. These treatments are similar to ABBV-400 in that they target specific pathways involved in tumor growth and immune evasion.

What other types of research exist?

Promising novel alternatives to ABBV-400 for esophageal cancer patients include Pembrolizumab, which has shown efficacy in the KEYNOTE-061 and KEYNOTE-181 trials, and Atezolizumab, which has been evaluated in various studies for its effectiveness in treating advanced solid tumors. Both drugs are immune checkpoint inhibitors and have demonstrated potential in improving survival and quality of life in patients with advanced esophageal cancer.

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Monoclonal Antibodies

ABBV-400 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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)

Must not have

Unresolved AEs > Grade 1 from prior anticancer therapy except for alopecia

History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ABBV-400, a new drug, on adults with difficult-to-treat cancers. The goal is to see how safe it is and how well it works. Patients will be monitored frequently.

Who is the study for?

Adults with certain advanced solid tumors like liver, pancreatic, biliary tract cancers, esophageal squamous cell carcinoma, triple negative breast cancer, hormone receptor+/HER2- breast cancer or head and neck squamous-cell-carcinoma. Participants must have measurable disease activity and meet specific laboratory criteria without active lung issues or recent other cancer treatments.

What is being tested?

The trial is testing ABBV-400 as a monotherapy for up to two years in adults with various advanced solid tumors. Patients are grouped based on their type of cancer and will receive regular medical assessments including blood tests and questionnaires to monitor the treatment's effect.

What are the potential side effects?

Specific side effects of ABBV-400 aren't listed but generally may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection, potential organ inflammation or allergic reactions. Regular monitoring aims to identify any adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an autoimmune or inflammatory condition affecting my lungs, or I've had a lung removed.

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I have been diagnosed with a specific type of advanced cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no ongoing side effects from cancer treatment above mild, except for hair loss.

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I have a history of serious lung problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Antidrug Antibody (ADA)

Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration

Clinical Benefit Rate

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Cohort 8: PROC/Primary Peritoneal/Fallopian Tube CancerExperimental Treatment1 Intervention

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.

Group II: Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)Experimental Treatment1 Intervention

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.

Group III: Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)Experimental Treatment1 Intervention

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.

Group IV: Cohort 5: Triple Negative Breast Cancer (TNBC)Experimental Treatment1 Intervention

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.

Group V: Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)Experimental Treatment1 Intervention

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.

Group VI: Cohort 3: Biliary Tract Cancers (BTC)Experimental Treatment1 Intervention

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.

Group VII: Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)Experimental Treatment1 Intervention

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.

Group VIII: Cohort 1: Hepatocellular Carcinoma (HCC)Experimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for esophageal cancer include chemotherapy, radiation therapy, and targeted therapies. Chemotherapy uses drugs like cisplatin and fluorouracil to kill rapidly dividing cancer cells by damaging their DNA or interfering with cell division. Radiation therapy uses high-energy rays to destroy cancer cells by causing DNA damage. Targeted therapies, such as those targeting the HER2 protein in HER2-positive cancers, work by interfering with specific molecules involved in cancer cell growth and survival. Investigational drugs like ABBV-400, which are being studied for advanced solid tumors, often target specific pathways or proteins unique to cancer cells, aiming to minimize damage to normal cells and improve treatment efficacy. Understanding these mechanisms is crucial for esophageal cancer patients as it helps in selecting the most appropriate and potentially effective treatment options based on the molecular characteristics of their cancer.