What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immunotherapy, and investigational drugs like ABBV-400. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased infection risk. Immunotherapy may lead to immune-related side effects like rash, colitis, pneumonitis, and thyroid dysfunction. Investigational drugs like ABBV-400, still under study, may have side effects common to both chemotherapy and immunotherapy, as well as unique adverse events specific to the drug.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC) that involve immunotherapy and combination therapies. Pembrolizumab, an anti-PD-1 therapy, has been approved in combination with chemotherapy for both squamous and non-squamous NSCLC, showing significant improvements in overall survival and progression-free survival. Atezolizumab, another immunotherapy drug, has been approved in combination with bevacizumab and chemotherapy for advanced non-squamous NSCLC, demonstrating enhanced efficacy in clinical trials. These treatments are similar to the investigational drug ABBV-400, which is being studied for its potential in treating advanced solid tumors, including NSCLC.

What other types of research exist?

Promising novel alternatives to ABBV-400 for NSCLC patients include: 1) Regorafenib, 2) Cabozantinib, 3) Sorafenib, 4) Lenvatinib plus etoposide and ifosfamide. These agents have shown some activity in clinical trials and may offer new treatment options for NSCLC patients.

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Monoclonal Antibodies

ABBV-400 for Advanced Solid Cancers

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 24

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called ABBV-400 for adults with advanced cancers. The study aims to find the best dose and see how well it works, both alone and with other treatments. Patients will receive the drug through an IV and be closely monitored for effects and side effects.

Who is the study for?

This trial is for adults with advanced solid tumors, including non-small cell lung cancer (NSCLC) with or without EGFR mutations, gastroesophageal adenocarcinoma, and colorectal cancer that have progressed after prior treatments. Participants must be in good physical condition (ECOG 0 or 1), have measurable disease, meet specific lab criteria, and not be candidates for surgery or other beneficial therapies.

What is being tested?

The study tests ABBV-400's safety and effect on tumor activity in patients with various advanced cancers. It involves a dose escalation phase to find the best dose followed by an expansion phase to confirm it. Patients will receive different doses of ABBV-400 intravenously at multiple global sites.

What are the potential side effects?

Potential side effects include increased treatment burden compared to standard care. Regular medical assessments will monitor any adverse events from ABBV-400 which may involve organ-specific inflammation like pneumonitis, as well as general reactions related to IV drug administration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 24

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

Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1

Overall survival (OS)

PFS per RECIST v1.1

Awards & Highlights

No Placebo-Only Group

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

Trial Design

12Treatment groups

Experimental Treatment

Group I: Part 7biii (Combination Comparator)Experimental Treatment2 Interventions

Participants with CRC will receive trifluridine/tipiracil (TAS-102) in combination with bevacizumab.

Group II: Part 7bii (Combination Dose Optimization High Dose)Experimental Treatment2 Interventions

Participants with CRC will receive the high dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab.

Group III: Part 7bi (Combination Dose Optimization Low Dose)Experimental Treatment2 Interventions

Participants with CRC will receive the low dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab.

Group IV: Part 7a (Combination Dose Escalation)Experimental Treatment2 Interventions

Participants with CRC will receive escalating doses of ABBV-400 in combination with bevacizumab.

Group V: Part 6 (MET Mutation)Experimental Treatment1 Intervention

Participants with MET mutation will receive ABBV-400 at the RP2D and various dose levels for dose optimization.

Group VI: Part 5 (MET Amplification)Experimental Treatment1 Intervention

Participants with mesenchymal-epithelial transition proto-oncogene (MET) amplification will receive ABBV-400 at the RP2D and various dose levels for dose optimization.

Group VII: Part 4 (Colorectal Cancer)Experimental Treatment1 Intervention

Participants with Colorectal Cancer (CRC) will receive ABBV-400 at the RP2D and various dose levels for dose optimization.

Group VIII: Part 3 (Gastroesophageal Adenocarcinoma/Gastroesophagel JunctExperimental Treatment1 Intervention

Participants with gastroesophageal adenocarcinoma will receive ABBV-400 at the RP2D.

Group IX: Part 2iii (Squamous NSCLC)Experimental Treatment1 Intervention

Participants with squamous NSCLC will receive ABBV-400 at RP2D.

Group X: Part 2ii (mutEGFR NSCLC)Experimental Treatment1 Intervention

Participants with non-Squamous mutEGFR NSCLC will receive ABBV-400 at RP2D.

Group XI: Part 2i (wtEGFR Non-Small Cell Lung Cancer [NSCLC])Experimental Treatment1 Intervention

Participants with non-squamous wtEGFR NSCLC will receive ABBV-400 at the Recommended Phase 2 dose (RP2D).

Group XII: Part 1 (Monotherapy Dose Escalation)Experimental Treatment1 Intervention

Participants with advanced solid tumors will receive escalating doses of ABBV-400.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trifluridine/Tipiracil

2019

Completed Phase 3

~760

Bevacizumab

2013

Completed Phase 4

~5540

Do I qualify?Apply below to find out

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 Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but also affects normal cells, leading to side effects. Immunotherapy, such as PD-1/PD-L1 inhibitors, boosts the immune system's ability to fight cancer by blocking proteins that inhibit immune responses. Targeted therapies, like EGFR inhibitors, focus on specific genetic mutations in cancer cells, offering more precise treatment with potentially fewer side effects. These mechanisms are vital for NSCLC patients as they guide the selection of the most effective and personalized treatment options.