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Antibody-Drug Conjugate
ABBV-399 for Advanced Cancers
Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must have advanced Non-Small Cell Lung Cancer (NSCLC) that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
Participants in the combination therapy Arm E must have metastatic/locally advanced nonsquamous NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) del19 or L858R, with or without T790M mutation, and none of the EGFR mutations known to be resistant to osimertinib.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing a new drug, ABBV-399, to see if it is safe and effective in treating people with advanced solid tumors. The drug will be tested alone and in combination with other drugs.
Who is the study for?
This trial is for adults with advanced solid tumors likely to express c-Met. They should have an ECOG Performance Status of 0-2, adequate organ function, and no more than two prior systemic therapies. Women must test negative for pregnancy. Participants can't join if they've had recent anticancer treatments, lung disease requiring steroids, unresolved side effects from previous cancer therapy (except hair loss or anemia), major surgery within the last three weeks, certain immunological conditions or medications.Check my eligibility
What is being tested?
The study is testing ABBV-399 alone and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors that express a specific protein called c-Met. The monotherapy arms are closed; now it's about how ABBV-399 works when combined with other drugs.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs which may mimic symptoms of autoimmune diseases. There could also be issues like fatigue and digestive disturbances due to the body's response to these powerful medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced lung cancer cannot be treated with surgery or other effective therapies.
Select...
My advanced non-squamous NSCLC has specific EGFR mutations and no resistance to osimertinib.
Select...
My lung cancer is advanced, not mainly squamous, without certain mutations, and tests positive for c-Met.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
Maximum observed plasma concentration (Cmax)
Number of Participants with Adverse Events
+3 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Monotherapy Telisotuzumab vedotin(28-day dosing cycles)Experimental Treatment1 Intervention
Telisotuzumab vedotin will be administered at escalating dose levels in 28-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin.
Group II: Monotherapy Telisotuzumab vedotin (21-day dosing cycles)Experimental Treatment1 Intervention
Telisotuzumab vedotin will be administered at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin.
Group III: Monotherapy Expansion CohortExperimental Treatment1 Intervention
Telisotuzumab vedotin will be administered every 14 days on a 28-day dosing cycle.
Group IV: Arm E (Telisotuzumab vedotin plus Osimertinib)Experimental Treatment2 Interventions
Telisotuzumab vedotin to be evaluated with Osimertinib.
Group V: Arm D (Telisotuzumab vedotin plus Nivolumab)Experimental Treatment2 Interventions
Telisotuzumab vedotin to be evaluated with Nivolumab.
Group VI: Arm A (Telisotuzumab vedotin plus Erlotinib)Experimental Treatment2 Interventions
Telisotuzumab vedotin to be evaluated with Erlotinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Osimertinib
2017
Completed Phase 4
~1010
Erlotinib
2011
Completed Phase 4
~2290
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
954 Previous Clinical Trials
500,868 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,702 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had lung radiation therapy less than 6 months ago.My cancer has spread to my brain and is not under control.I have not had major surgery in the last 3 weeks.I have a condition that makes it unsafe for me to take ABBV-399 with certain medications.My advanced lung cancer cannot be treated with surgery or other effective therapies.I am eligible for erlotinib or nivolumab treatment according to local guidelines.My advanced non-squamous NSCLC has specific EGFR mutations and no resistance to osimertinib.My lung cancer is advanced, not mainly squamous, without certain mutations, and tests positive for c-Met.I have not taken nivolumab.I can care for myself and am up and about more than 50% of my waking hours.I have had lung conditions treated with steroids.I do not have COVID-19, nor have I been exposed to it in the last 14 days.My bone marrow, kidneys, and liver are functioning well.I haven't had cancer treatment or taken herbal therapy shortly before starting ABBV-399.I have had lung scarring or lung inflammation within the last 3 months.I have side effects from cancer treatment that are still bothering me, except for hair loss or low blood count.
Research Study Groups:
This trial has the following groups:- Group 1: Arm D (Telisotuzumab vedotin plus Nivolumab)
- Group 2: Monotherapy Telisotuzumab vedotin (21-day dosing cycles)
- Group 3: Arm A (Telisotuzumab vedotin plus Erlotinib)
- Group 4: Monotherapy Telisotuzumab vedotin(28-day dosing cycles)
- Group 5: Monotherapy Expansion Cohort
- Group 6: Arm E (Telisotuzumab vedotin plus Osimertinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What adverse reactions have been documented to be associated with the use of Osimertinib?
"Having conducted a thorough assessment of the available data, our team has concluded that Osimertinib is relatively safe and assigned it with a score of 1. This conservative rating reflects the fact that this study is in its earliest stages."
Answered by AI
Is recruitment still underway for this clinical trial?
"This trial, which was posted to clinicaltrials.gov on the 15th of January 2014 and amended most recently on November 9th 2022, is currently soliciting applicants."
Answered by AI
How many individuals have been recruited to participate in this clinical experiment?
"AbbVie's trial sponsors necessitate 260 participants that meet the inclusion criteria. The study will take place across multiple sites, including New york Presbyterian Hospital Weill Cornell Medical Center in Manhattan ID# 218445 and Virginia Cancer Specialists in Fairfax with ID# 165708."
Answered by AI
To what purpose is the drug Osimertinib typically employed?
"Osimertinib is traditionally associated with treating unresectable melanoma. Nevertheless, it has also been known to be effective in dealing with metastatic esophageal adenocarcinoma and various forms of malignant neoplasms including squamous cell carcinoma."
Answered by AI
Have other reports or investigations been conducted concerning Osimertinib?
"At present, 859 scientific studies are being undertaken to better understand osimertinib. Out of these investigations, 105 have advanced to a Phase 3 clinical trial stage. The majority of the trials for this drug have been set up in Nagoya-shi and California; however, there is a total of 47609 locations running experiments on osimertinib worldwide."
Answered by AI
How many healthcare facilities are currently conducting this research experiment?
"This clinical trial is presently recruiting out of 13 locations scattered throughout the United States, with prominent sites in New york, Fairfax and Duarte. Participants should consider the nearest site to diminish their travel requirements if selected for enrollment."
Answered by AI
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