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Monoclonal Antibodies
Ado-Trastuzumab Emtansine for Cancer
Phase 2
Recruiting
Led By Bob Li, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 2 years
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can help people with cancer that has come back or spread, and that has the HER2 gene.
Who is the study for?
This trial is for adults with advanced solid tumors linked to HER2 gene changes, who are in good physical condition (Karnofsky Performance Status ≥70%), have adequate blood cell counts, and agree to use effective contraception. It's not for those who've had ado-trastuzumab emtansine before, are pregnant/breastfeeding, have certain heart conditions or lung diseases, or severe allergies to the drug's components.Check my eligibility
What is being tested?
The study tests the effects of ado-trastuzumab emtansine on cancers thought to be driven by abnormal HER2 genes. Participants must have measurable cancer signs and meet specific genetic criteria confirmed by a certified lab. The trial includes various cohorts based on different types of HER2 mutations or amplifications.See study design
What are the potential side effects?
Potential side effects include liver issues, heart problems like reduced ejection fraction leading to congestive heart failure symptoms, nerve damage resulting in peripheral neuropathy, and reactions related to drug components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
best overall response (ORR)
Side effects data
From 2017 Phase 1 trial • 17 Patients • NCT0203801091%
Aspartate Aminotransferase Increased
82%
Hyperglycemia
82%
Peripheral Sensory Neuropathy
73%
Anemia
73%
Fatigue
64%
Hypokalemia
64%
Hypoalbuminemia
64%
Alkaline Phosphatase Increased
55%
Cough
55%
Rash Maculo-papular
55%
Lymphocyte Count Decrease
55%
Platelet Count Decrease
45%
Alanine Aminotransferase Increased
45%
Blood Bilirubin Increased
45%
Sinus Tachycardia
36%
Elevated Hemoglobin A1C
36%
Nausea
36%
Dry Mouth
36%
Headache
27%
Epistaxis
27%
Diarrhea
27%
Hypocalcemia
27%
White Blood Cell Decrease
27%
Blurred Vision
27%
Urinary Tract Infection
27%
Neutrophil Count Decrease
18%
Anorexia
18%
Hypertension
18%
Dyspnea
18%
Activated Partial Thromboplastin Time Prolonged
18%
Pain
18%
Electrocardiogram QT Corrected Interval Prolonged
18%
Weight Loss
18%
Constipation
18%
Edema Limbs
18%
Dizziness
9%
Post- Menopausal Bleeding
9%
Left Ventricular Systolic Dysfunction
9%
Abdominal Pain
9%
Pancreatitis
9%
Fractured Rib
9%
Floaters
9%
Palpitations
9%
Right Bundle Block
9%
Acute pancreatitis
9%
Dry Eye
9%
Mucosal Infection
9%
Back Pain
9%
Hematuria
9%
Non-Cardiac Chest Pain
9%
Insomnia
9%
Sebaceous Cyst
9%
Pancreatic Insufficiency
9%
Ascites
9%
Elevated Fasting Plasma
9%
Alopecia
9%
Hypoxemia
9%
Urinary Incontinence
9%
Fever
9%
Radiation Recall Reaction (Dermatologic)
9%
Ear Pain
9%
Hypernatremia
9%
Anxiety
9%
Palmar-plantar Erythrodysesthesia Syndrome
9%
Lymphedema
9%
Pneumonitis
9%
Hypoglycemia
9%
Bloating
9%
Mucositis Oral
9%
Bullous Dermatitis
9%
Pruritus
9%
Sinus Bradycardia
9%
Gastroesophageal Reflux Disease
9%
Chills
9%
Lymphocyte Count Increase
9%
Hypercalcemia
9%
Arthralgia
9%
Chest Wall Pain
9%
Sinus Pain
9%
Hoarseness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)
Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)
Trial Design
6Treatment groups
Experimental Treatment
Group I: Cohort 6: Other solid cancersExperimental Treatment1 Intervention
Group II: Cohort 5: Salivary gland cancersExperimental Treatment1 Intervention
Group III: Cohort 4: Endometrial cancersExperimental Treatment1 Intervention
Group IV: Cohort 3: Colorectal cancersExperimental Treatment1 Intervention
Group V: Cohort 2: Lung cancers, HER2 amplifiedExperimental Treatment1 Intervention
Group VI: Cohort 1: Lung cancers, HER2 mutantExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ado-trastuzumab emtansine
2014
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,480 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,549 Total Patients Enrolled
Bob Li, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to perform daily activities with some difficulty.You have a type of irregular heart rhythm that needs to be treated and is not currently stable.Your blood platelet count is at least 100,000 per microliter within 30 days before the start of the study.Your bilirubin level must be within a certain range, unless you have Gilbert's syndrome, in which case it can be slightly higher.You have had a lung disease called interstitial lung disease or pneumonitis in the past.You have not been treated with ado-trastuzumab emtansine, but if you have received other medications targeting HER2, you can still participate.You have moderate to severe symptoms of congestive heart failure.You had a heart attack or unstable chest pain within the past 6 months.You are allergic to any part of ado-trastuzumab emtansine.Your cancer can be measured or evaluated using specific criteria, and if not, there may be other criteria that can be used for evaluation.Your absolute neutrophil count is at least 1,000 per microliter within 30 days before starting the trial.You have a specific type of HER2 mutation in your lung cancer, confirmed by a CLIA-certified laboratory.Women who can have babies need to have a negative pregnancy test within 2 weeks before joining the study. This applies to women who can still have babies and those who have gone through menopause less than a year ago.You have received a high total dose of certain types of chemotherapy drugs in the past.You have severe nerve damage in your arms or legs.You must be 18 years or older.You have been diagnosed with advanced solid tumor cancers through a pathology test.For specific groups, you must have a documented HER2 amplification identified by certain approved tests. If your HER2 amplification is identified by a different method, you must get approval from the Principal Investigator to participate in a different group.Your heart's pumping function is good, with a measurement of at least 50% on a heart scan.Your liver enzymes need to be within a certain range, and if you have cancer that has spread to your liver, the range is a bit higher.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 6: Other solid cancers
- Group 2: Cohort 1: Lung cancers, HER2 mutant
- Group 3: Cohort 2: Lung cancers, HER2 amplified
- Group 4: Cohort 3: Colorectal cancers
- Group 5: Cohort 4: Endometrial cancers
- Group 6: Cohort 5: Salivary gland cancers
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.
How many participants are involved in the research initiative?
"Affirmative. Information found on clinicaltrials.gov demonstrates that this medical research, which was first announced in February 2016, is now actively searching for participants. A total of 140 patients need to be enrolled from 8 different locations."
Answered by AI
Has ado-trastuzumab emtansine been officially sanctioned by the FDA?
"Our team at Power assigns a rating of 2 to ado-trastuzumab emtansine, as there is evidence in favor of its safety but no information about efficacy yet."
Answered by AI
In which locations is this trial currently being conducted?
"8 centres are presently running this clinical trial. Participants may find it handy to select the clinic nearest them, thereby reducing travel requirements; these 8 sites can be found in Commack, Basking Ridge, Uniondale and other cities."
Answered by AI
Is this a pioneering endeavor in the medical field?
"Research into the efficacy of ado-trastuzumab emtansine began in 2008, when a trial sponsored by Hoffmann-La Roche oversaw 720 patients. This data was used to gain Phase 2 drug approval for this medication and since then 41 clinical trials have been initiated internationally, spanning 57 nations across 1451 cities."
Answered by AI
Are there any current opportunities to apply for this trial?
"Affirmative. According to clinicaltrials.gov, the trial is still seeking recruits for its study which was initially listed on February 1st 2016 and recently updated on September 7th 2022. At present, 140 people are needed across 8 different sites involved in this experiment."
Answered by AI
Are there any documented occurrences of ado-trastuzumab emtansine being used in prior medical experiments?
"Currently, 41 trials are ongoing for ado-trastuzumab emtansine. Nine of these investigations have reached Phase 3 and the majority of them take place in Brewer, Maine. Nevertheless, there is a worldwide presence with 5997 different clinical sites running studies on this medication."
Answered by AI
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