Monoclonal Antibodies
ABBV-400 for Non-Small Cell Lung 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
If applicable, an immune checkpoint inhibitor.
If applicable, appropriate available therapies, including HER2-directed therapies.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to month 24
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing the investigational drug ABBV-400 to see if it is effective and safe in treating advanced solid tumors.
Eligible Conditions
- Non-Small Cell Lung Cancer
- Solid Tumors
- Gastroesophageal Adenocarcinoma
- Colorectal Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
If you are currently receiving treatment with an immune checkpoint inhibitor medication.
Select...
If there are other effective treatments available for your condition, you may not be eligible for this study.
Select...
If you are eligible for targeted therapy based on your specific condition.
Select...
You have a type of cancer that has spread and has not responded to standard treatments. Surgery or other approved treatments have not been successful in treating your cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 24
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Group I: 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 II: Part 4 (Colorectal Cancer)Experimental Treatment1 Intervention
Participants with Colorectal Cancer will receive ABBV-400 at the RP2D and various dose levels for dose optimization.
Group III: Part 3 (Gastroesophageal Adenocarcinoma/Gastroesophagel Junction Adenocarcinoma)Experimental Treatment1 Intervention
Participants with gastroesophageal adenocarcinoma will receive ABBV-400 at the RP2D.
Group IV: Part 2iii (Squamous NSCLC)Experimental Treatment1 Intervention
Participants with squamous NSCLC will receive ABBV-400 at RP2D.
Group V: Part 2ii (mutEGFR NSCLC)Experimental Treatment1 Intervention
Participants with non-Squamous mutEGFR NSCLC will receive ABBV-400 at RP2D.
Group VI: 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 VII: Part 1 (Monotherapy Dose Escalation)Experimental Treatment1 Intervention
Participants with advanced solid tumors will receive escalating doses of ABBV-400.
Find a site
Who is running the clinical trial?
AbbVieLead Sponsor
899 Previous Clinical Trials
484,881 Total Patients Enrolled
ABBVIE INC.Study Director
AbbVie346 Previous Clinical Trials
129,661 Total Patients Enrolled
Media Library
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