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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

Study Summary

This trial is testing the investigational drug ABBV-400 to see if it is effective and safe in treating advanced solid tumors.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1
Overall survival (OS)
PFS per RECIST v1.1

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
Bevacizumab
2013
Completed Phase 4
~5280
Trifluridine/Tipiracil
2019
Completed Phase 3
~760

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.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
982 Previous Clinical Trials
507,384 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
412 Previous Clinical Trials
149,795 Total Patients Enrolled

Media Library

ABBV-400 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05029882 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Part 7bii (Combination Dose Optimization High Dose), Part 2ii (mutEGFR NSCLC), Part 7biii (Combination Comparator), Part 1 (Monotherapy Dose Escalation), Part 4 (Colorectal Cancer), Part 5 (MET Amplification), Part 7a (Combination Dose Escalation), Part 2i (wtEGFR Non-Small Cell Lung Cancer [NSCLC]), Part 2iii (Squamous NSCLC), Part 3 (Gastroesophageal Adenocarcinoma/Gastroesophagel Junct, Part 6 (MET Mutation), Part 7bi (Combination Dose Optimization Low Dose)
Non-Small Cell Lung Cancer Clinical Trial 2023: ABBV-400 Highlights & Side Effects. Trial Name: NCT05029882 — Phase 1
ABBV-400 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05029882 — Phase 1
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