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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 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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

964 Previous Clinical Trials

502,525 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

402 Previous Clinical Trials

147,099 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being admitted for this clinical experiment?

"This medical experiment calls for 220 qualified patients to enrol. Those looking to participate can head over to START Midwest in Grand Rapids, Michigan (ID# 231551) or Community Health Network, Inc. /ID# 245331 which is located in Indianapolis, Indiana)."

Answered by AI

Are there multiple sites that are conducting this experiment?

"Patients are presently being recruited across 9 different medical sites, which include locations in Grand Rapids, Indianapolis and Santa Monica. To reduce the burden of travel for participants, it is advised to select the nearest clinic when enrolling."

Answered by AI

What safety assurances exist for administering ABBV-400 to patients?

"ABBV-400 has not yet been tested extensively in humans, so it received a score of 1 on our scale. This trial is currently at its initial phase and limited data supports the safety and efficacy of this drug."

Answered by AI

Are there any vacancies available to participate in this experiment?

"The information hosted on clinicaltrials.gov affirms that recruitment for this trial is currently ongoing; the study was first posted October 13th 2021 and most recently edited September 16th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

2021. "Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05029882.

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