NCT02675829

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P75+ for phase_2

Timeline
6mo left

Started Feb 2016

Longer than P75 for phase_2

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Feb 2016Feb 2027

Study Start

First participant enrolled

February 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

11 years

First QC Date

February 3, 2016

Last Update Submit

March 2, 2026

Conditions

Solid Tumor CancersLung CancerBladder CancerUrinary Tract Cancers

Keywords

HER2 mutantHER2 amplifiedAdo-Trastuzumab Emtansine15-335

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Study Arms (6)

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

Interventions

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.

Cohort 1: Lung cancers, HER2 mutantCohort 2: Lung cancers, HER2 amplifiedCohort 3: Colorectal cancersCohort 4: Endometrial cancersCohort 5: Salivary gland cancersCohort 6: Other solid cancers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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.
  • Women who are pregnant or breast-feeding.
  • Known hypersensitivity to any component of ado-trastuzumab emtansine.
  • History of interstitial lung disease or pneumonitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Publications (2)

  • 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.

    PMID: 32923849DERIVED

  • Li 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.

    PMID: 29989854DERIVED

Related Links

MeSH Terms

Conditions

Lung NeoplasmsUrinary Bladder NeoplasmsUrologic Neoplasms

Interventions

Ado-Trastuzumab Emtansine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MaytansineMacrolidesLactonesOrganic ChemicalsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsTrastuzumabAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jamie Chaft, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 5, 2016

Study Start

February 1, 2016

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

US(7)