Solid Tumor CancersPhase 2NCT02675829
Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers
A Phase 2 study testing ado-trastuzumab emtansine in people with Solid Tumor Cancers and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to find out what effects, a drug called ado-trastuzumab emtansine has on the patient and their cancer which is thought to be controlled by the abnormal HER2 gene. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancers, Lung Cancer, Bladder Cancer
- What is being tested?
- ado-trastuzumab emtansine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Feb 2016to 4 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who are ≥18 years old.
- Pathologically confirmed advanced solid tumor cancers
- For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator
- For Cohorts 2, 3, 4, 5, 6 documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. Patients with HER2 amplification identified by another method or criteria must be approved by the Principal Investigator and may enroll in the "Other" Cohort 4.
- Measurable or evaluable indicator lesion(s) as defined by RECIST v1.1. Patients without RECIST measurable disease will be eligible for enrollment to "Other" cohort provided their disease can be evaluated using another accepted response criteria (e.g. Gynecologic Cancer InterGroup (GCIG) CA125 Response Criteria, modified PET Response Criteria in Solid Tumors (PERCIST)). Patients with salivary gland cancers (Cohort 5) may be eligible on the basis of evaluable disease on modified PET.
- Karnofsky Performance Status 70% or above.
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- Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
- Negative β-human chorionic gonadotropin (hCG) pregnancy test within 2 weeks before enrollment for premenopausal women of reproductive capacity and for women less than 12 months after menopause. Pregnancy screening will be conducted for women up to the age of 50 years per institutional standard.
- Women of childbearing potential must agree to use of a highly effective method of contraception. Effective contraception is required during treatment and for 7 months following the last dose for female participants of reproductive potential and during treatment and for 4 months following the last dose for male participants with female sexual partners of reproductive potential. Male participants should also refrain from donating sperm during treatment and for 4 months following the last dose.
- Absolute neutrophil count ≥ 1,000/µL within 30 days prior to C1D1
- Platelet count ≥ 100,000/µL within 30 days prior to C1D1
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), in case of Gilbert's syndrome, ≤ 2x ULN within 30 days prior to C1D1
- Aspartate aminotransferase and/or alanine aminotransferase ≤ 3 x ULN (≤ 5 x ULN if liver metastases are present) within 30 days prior to C1D1
- Provide written, informed consent to participate in the study and follow the study procedures
Who cannot join
- Prior therapy resulting in cumulative epirubicin dose ≥ 900mg/m2 or cumulative doxorubicin dose ≥ 500mg/m2 or equivalent dose of another anthracycline.
- Prior therapy with ado-trastuzumab emtansine (patients who had prior trastuzumab or other HER2 targeted agents are eligible).
- Symptomatic congestive heart failure (New York Heart Association Classification II-IV).
- Myocardial infarction or unstable angina within 6 months of enrollment.
- Unstable ventricular arrhythmia requiring treatment.
- Grade 3 or worse peripheral neuropathy as defined by CTCAE v4.1.
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- Women who are pregnant or breast-feeding.
- Known hypersensitivity to any component of ado-trastuzumab emtansine.
- History of interstitial lung disease or pneumonitis.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: A Phase 2 Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers
The purpose of this study is to find out what effects, a drug called ado-trastuzumab emtansine has on the patient and their cancer which is thought to be controlled by the abnormal HER2 gene.
- Being tested
- ado-trastuzumab emtansine
- Keywords
- HER2 mutant, HER2 amplified, Ado-Trastuzumab Emtansine, 15-335
- Medical subject headings
- Lung Neoplasms, Urinary Bladder Neoplasms, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ado-trastuzumab emtansineDrug
Ado-trastuzumab emtansine is administered intravenously at 3.6 mg/kg every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Lung cancers, HER2 mutant | Experimental | Not described Receives: Drug: ado-trastuzumab emtansine |
| Cohort 2: Lung cancers, HER2 amplified | Experimental | Not described Receives: Drug: ado-trastuzumab emtansine |
| Cohort 3: Colorectal cancers | Experimental | Not described Receives: Drug: ado-trastuzumab emtansine |
| Cohort 4: Endometrial cancers | Experimental | Not described Receives: Drug: ado-trastuzumab emtansine |
| Cohort 5: Salivary gland cancers | Experimental | Not described Receives: Drug: ado-trastuzumab emtansine |
| Cohort 6: Other solid cancers | Experimental | Not described Receives: Drug: ado-trastuzumab emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
best overall response (ORR)
As soon as evaluations for each tumor assessment are completed, the Investigator should assess the patient's overall response (target plus non- target lesions) based on criteria and overall response algorithms as defined in RECIST version 1.1. Scans must be assessable for all evaluations.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start16 Feb 2016
- Primary completion4 Sep 2026
- Study completion4 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor CancersStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Jamie Chaft, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675829
- Sponsor's protocol ID
- 15-335
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2016
- Last updated
- 9 Sep 2026
- Results posted
- No
Publications
Mondaca S, Razavi P, Xu C, Offin M, Myers M, Scaltriti M, Hechtman JF, Bradley M, O'Reilly EM, Berger MF, Solit DB, Li BT, Abou-Alfa GK. Genomic Characterization of ERBB2-Driven Biliary Cancer and a Case of Response to Ado-Trastuzumab Emtansine. JCO Precis Oncol. 2019 Oct 17;3:PO.19.00223. doi: 10.1200/PO.19.00223. eCollection 2019.
PubMed 32923849Li BT, Shen R, Buonocore D, Olah ZT, Ni A, Ginsberg MS, Ulaner GA, Offin M, Feldman D, Hembrough T, Cecchi F, Schwartz S, Pavlakis N, Clarke S, Won HH, Brzostowski EB, Riely GJ, Solit DB, Hyman DM, Drilon A, Rudin CM, Berger MF, Baselga J, Scaltriti M, Arcila ME, Kris MG. Ado-Trastuzumab Emtansine for Patients With HER2-Mutant Lung Cancers: Results From a Phase II Basket Trial. J Clin Oncol. 2018 Aug 20;36(24):2532-2537. doi: 10.1200/JCO.2018.77.9777. Epub 2018 Jul 10.
PubMed 29989854
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers
- ClinicalTrials.gov ID
- NCT02675829
- Acronym / sponsor ID
- 15-335
- Keywords
- HER2 mutant, HER2 amplified, Ado-Trastuzumab Emtansine, 15-335
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 4 Sep 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out what effects, a drug called ado-trastuzumab emtansine has on the patient and their cancer which is thought to be controlled by the abnormal HER2 gene.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Lung cancers, HER2 mutant | Experimental | Drug: ado-trastuzumab emtansine |
| Cohort 2: Lung cancers, HER2 amplified | Experimental | Drug: ado-trastuzumab emtansine |
| Cohort 3: Colorectal cancers | Experimental | Drug: ado-trastuzumab emtansine |
| Cohort 4: Endometrial cancers | Experimental | Drug: ado-trastuzumab emtansine |
| Cohort 5: Salivary gland cancers | Experimental | Drug: ado-trastuzumab emtansine |
| Cohort 6: Other solid cancers | Experimental | Drug: ado-trastuzumab emtansine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adults who are ≥18 years old.
- Pathologically confirmed advanced solid tumor cancers
- For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator
- For Cohorts 2, 3, 4, 5, 6 documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. Patients with HER2 amplification identified by another method or criteria must be approved by the Principal Investigator and may enroll in the "Other" Cohort 4.
- Measurable or evaluable indicator lesion(s) as defined by RECIST v1.1. Patients without RECIST measurable disease will be eligible for enrollment to "Other" cohort provided their disease can be evaluated using another accepted response criteria (e.g. Gynecologic Cancer InterGroup (GCIG) CA125 Response Criteria, modified PET Response Criteria in Solid Tumors (PERCIST)). Patients with salivary gland cancers (Cohort 5) may be eligible on the basis of evaluable disease on modified PET.
Key exclusion criteria (9 listed)
- Prior therapy resulting in cumulative epirubicin dose ≥ 900mg/m2 or cumulative doxorubicin dose ≥ 500mg/m2 or equivalent dose of another anthracycline.
- Prior therapy with ado-trastuzumab emtansine (patients who had prior trastuzumab or other HER2 targeted agents are eligible).
- Symptomatic congestive heart failure (New York Heart Association Classification II-IV).
- Myocardial infarction or unstable angina within 6 months of enrollment.
- Unstable ventricular arrhythmia requiring treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ado-trastuzumab emtansineAdo-trastuzumab emtansine is administered intravenously at 3.6 mg/kg every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity. | Drug | Cohort 1: Lung cancers, HER2 mutant, Cohort 2: Lung cancers, HER2 amplified, Cohort 3: Colorectal cancers, Cohort 4: Endometrial cancers, Cohort 5: Salivary gland cancers, Cohort 6: Other solid cancers |
Primary outcome
best overall response (ORR)
Time frame: 2 years
As soon as evaluations for each tumor assessment are completed, the Investigator should assess the patient's overall response (target plus non- target lesions) based on criteria and overall response algorithms as defined in RECIST version 1.1. Scans must be assessable for all evaluations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 32923849Mondaca S, Razavi P, Xu C, Offin M, Myers M, Scaltriti M, Hechtman JF, Bradley M, O'Reilly EM, Berger MF, Solit DB, Li BT, Abou-Alfa GK. Genomic Characterization of ERBB2-Driven Biliary Cancer and a Case of Response to Ado-Trastuzumab Emtansine. JCO Precis Oncol. 2019 Oct 17;3:PO.19.00223. doi: 10.1200/PO.19.00223. eCollection 2019.
- Derived from this study: PubMed 29989854Li BT, Shen R, Buonocore D, Olah ZT, Ni A, Ginsberg MS, Ulaner GA, Offin M, Feldman D, Hembrough T, Cecchi F, Schwartz S, Pavlakis N, Clarke S, Won HH, Brzostowski EB, Riely GJ, Solit DB, Hyman DM, Drilon A, Rudin CM, Berger MF, Baselga J, Scaltriti M, Arcila ME, Kris MG. Ado-Trastuzumab Emtansine for Patients With HER2-Mutant Lung Cancers: Results From a Phase II Basket Trial. J Clin Oncol. 2018 Aug 20;36(24):2532-2537. doi: 10.1200/JCO.2018.77.9777. Epub 2018 Jul 10.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Chaft, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ado-trastuzumab emtansine in people with Solid Tumor Cancers and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best overall response (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675829, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.