NCT04647838

Brief Summary

The aim of this study is to understand efficacy of tepotinib in patients with solid cancers harbouring c-MET amplification or exon 14 mutation who progressed after standard treatment for metastatic disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Typical duration for phase_2

Geographic Reach
1 country

22 active sites

Status
unknown

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 Start

First participant enrolled

January 16, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

December 2, 2020

Status Verified

November 1, 2020

Enrollment Period

3.1 years

First QC Date

November 23, 2020

Last Update Submit

November 30, 2020

Conditions

Solid TumorMET Exon 14 Skipping MutationMET Amplification

Keywords

solid tumorsMET Exon 14MET AmplificationcMETlungneoplasmcMET amplificationMETex14cancerMET Exon 14 skipping

Outcome Measures

Primary Outcomes (1)

  • Objective response rates (RECIST1.1)

    Objective response will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator. Objective response is defined as either a confirmed complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

    Baseline up to 20 months

Secondary Outcomes (4)

  • Progression free survival

    Baseline until PD or death within 84 days of last tumor assessment; assessed up to 20 months

  • Disease control rate

    Baseline up to 20 months

  • Overall survival

    Baseline until death, assessed up to 20 months

  • Toxicity and drug compliance

    From the first dose of study drug administration until 33 days after the last dose of study drug administration, assessed up to 20 Months

Study Arms (2)

NSCLC

EXPERIMENTAL

Tepotinib 500mg (2 tablets of 250mg) per day D1-21 orally, once daily

Drug: Tepotinib

Other cancers

EXPERIMENTAL

Tepotinib 500mg (2 tablets of 250mg) per day D1-21 orally, once daily

Drug: Tepotinib

Interventions

TepotinibDRUG

Tepotinib 500mg (2 tablets of 250mg) per day D1-21 orally, once daily

Also known as: MSC2156119J, EMD 1214063
NSCLCOther cancers

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed solid cancers (NSCLC, gastric cancer, colorectal cancer, breast cancer, hepatocellular cancer, head and neck cancer, RCC and other solid cancers)
  • Subjects who are not eligible for surgical and/or local-regional therapies or who have progressive disease (PD) after surgical and/or local-regional therapies
  • Subjects who have disease progression or are intolerant to the prior standard treatment for advanced solid cancers
  • A tumor biopsy (excluding fine needle aspiration and cytology samples) is required for determining MET status (a fresh pretreatment tumor biopsy is recommended but archived tumor sample is acceptable).
  • Patients with MET exon 14 skipping mutation detected by NGS method and c-MET copy number gain (≥6.0) in the archival or fresh tumor tissue specimen identified in K-MASTER panel. All genetic findings must be reviewed by the study Molecular Steering Committee, prior to study entry.
  • Male or female, 19 years of age or older
  • Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST v 1.1). The target lesion that has received previous local therapy should not be considered as measurable unless clear progression has been documented since the therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment
  • Life expectancy judged by the Investigator of at least 3 months

You may not qualify if:

  • \. Eligibility criteria:
  • Histologically or cytologically confirmed solid cancers (NSCLC, gastric cancer, colorectal cancer, breast cancer, hepatocellular cancer, head and neck cancer, RCC and other solid cancers)
  • Subjects who are not eligible for surgical and/or local-regional therapies or who have progressive disease (PD) after surgical and/or local-regional therapies
  • Subjects who have disease progression or are intolerant to the prior standard treatment for advanced solid cancers
  • A tumor biopsy (excluding fine needle aspiration and cytology samples) is required for determining MET status (a fresh pretreatment tumor biopsy is recommended but archived tumor sample is acceptable).
  • Patients with MET exon 14 skipping mutation detected by NGS method and c-MET copy number gain (≥6.0) in the archival or fresh tumor tissue specimen identified in K-MASTER panel. All genetic findings must be reviewed by the study Molecular Steering Committee, prior to study entry.
  • Male or female, 19 years of age or older
  • Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST v 1.1). The target lesion that has received previous local therapy should not be considered as measurable unless clear progression has been documented since the therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment
  • Life expectancy judged by the Investigator of at least 3 months
  • Prior treatment with any agent targeting the HGF/c-MET pathway
  • Prior EGFR therapy for EGFR activating mutant NSCLC
  • Patients who received local treatment within 4 weeks prior to the first administration of tepotinib (e.g., major surgery, radiation therapy, hepatic arterial embolization, transcatheter arterial chemoembolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation). NOTE: palliative radiotherapy should be completed at least 7 days prior to the first administration of the tepotinib.
  • Prior history of organ transplant
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Chonnam National University Hwasun Hospital

Hwasun, Chonnam, South Korea

ACTIVE NOT RECRUITING

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

ACTIVE NOT RECRUITING

Dankook University Hospital

Cheonan, South Korea

RECRUITING

Keimyung University Dongsan Hospital

Daegu, South Korea

ACTIVE NOT RECRUITING

Konyang University Hospital

Daejeon, South Korea

ACTIVE NOT RECRUITING

National Cancer Center

Goyang-si, South Korea

ACTIVE NOT RECRUITING

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, South Korea

ACTIVE NOT RECRUITING

Gachon University Gil Medical Center

Incheon, South Korea

ACTIVE NOT RECRUITING

The Catholic University of Korea Incheon St. Marry Hospital

Incheon, South Korea

ACTIVE NOT RECRUITING

Gyeongsang National University Hospital

Jinju, South Korea

ACTIVE NOT RECRUITING

Inje University Haeundae Pain Hospital

Pusan, South Korea

ACTIVE NOT RECRUITING

Kosin University Gaspel Hospital

Pusan, South Korea

ACTIVE NOT RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, South Korea

RECRUITING

Chungang University Hospital

Seoul, South Korea

ACTIVE NOT RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

ACTIVE NOT RECRUITING

Inje University Sanggye Paik Hospital

Seoul, South Korea

ACTIVE NOT RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

ACTIVE NOT RECRUITING

Samsung Medical Center

Seoul, South Korea

ACTIVE NOT RECRUITING

Seoul National University Hospital

Seoul, South Korea

ACTIVE NOT RECRUITING

Severance Hospital

Seoul, South Korea

ACTIVE NOT RECRUITING

Pusan National University Yangsan Hospital

Yangsan, South Korea

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

tepotinibEMD1214063

Study Officials

  • Ki Hyeong Lee, M.D.

    Chungbuk National University Hospital

    STUDY CHAIR

Central Study Contacts

Ki Hyeong Lee, M.D.

CONTACT

+82432696015kihlee@chungbuk.ac.kr

Eun Joo Kang, M.D.

CONTACT

+82226263061kkangju11@naver.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental: Arm 1\_NSCLC Patients with non-small cell lung cancer (NSCLC) harboring MET alteration Experimental: Arm 2\_Other solid tumors Solid tumors excluding NSCLC harboring MET alteration
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 1, 2020

Study Start

January 16, 2020

Primary Completion

February 28, 2023

Study Completion

August 31, 2024

Last Updated

December 2, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(22)