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Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer

Primary Purpose

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JMT101
Sponsored by
Shanghai JMT-Bio Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically or cytologically confirmed, locally advanced or metastatic NSCLC, harboring an EGFR exon 20 insertion mutation. ( non-irradiable, non-operable);
  • No previous treatment or first-line treatment failed NSCLC;
  • At least 1 measurable lesion according to RECIST 1.1;
  • ECOG score 0 or 1;

Exclusion Criteria:

  • Previously treated with EGFR antibody;
  • Symptomatic brain metastasis;
  • Interstitial pneumopathy;
  • Known hypersensitivity to any ingredient of JMT101, afatinib, osimertinib or their excipients;
  • Receiving an investigational product in another clinical study within 4 weeks;
  • History of serious systemic diseases;
  • History of serious autoimmune diseases;
  • Pregnancy or lactating women.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting
  • The Fourth Hospital of Hebei Medical UniversityRecruiting
  • Chinese Pla General HospitalRecruiting
  • Hunan Cancer HospitalRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Fujian Cancer HospitalRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Jiangsu Province Hospital of Chinese MedicineRecruiting
  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical SchoolRecruiting
  • Shanghai Chest Hospital, Shanghai Jiaotong UniversityRecruiting
  • Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)Recruiting
  • Shanxi Province Cancer HospitalRecruiting
  • Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose Escalation Cohort

Dose Expansion Cohort

Arm Description

Two dose levels of JMT101 combined with afatinib or osimertinib will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).

Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.

Outcomes

Primary Outcome Measures

Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).

Secondary Outcome Measures

Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
Disease control rate (DCR).
Progression free survival (PFS).
Overall survival (OS).
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
Maximum measured plasma concentration (Cmax) of JMT101.
Time to maximum plasma concentration (Tmax) of JMT101.
Half-life (T1/2) of JMT101.
Immunogenicity profile of JMT101.
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Potential biomarkers detected in plasma circulating tumor DNA.

Full Information

First Posted
June 16, 2020
Last Updated
December 23, 2020
Sponsor
Shanghai JMT-Bio Inc.
Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04448379
Brief Title
Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer
Official Title
A Phase Ib,Open Label,Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai JMT-Bio Inc.
Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a Phase Ib, open label, multi-center study of to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.
Detailed Description
The objective of the trial is to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (afatinib or osimertinib) in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Cohort
Arm Type
Experimental
Arm Description
Two dose levels of JMT101 combined with afatinib or osimertinib will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).
Arm Title
Dose Expansion Cohort
Arm Type
Experimental
Arm Description
Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
Intervention Type
Drug
Intervention Name(s)
JMT101
Other Intervention Name(s)
Afatinib or Osimertinib
Intervention Description
IV infusion Q2W for 4 weeks (28-day cycles)
Primary Outcome Measure Information:
Title
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
Time Frame
From enrollment until 30 days after the last dose
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
Time Frame
From first dose to disease progression or end of study, an average of 1 year
Title
Disease control rate (DCR).
Time Frame
From first dose to disease progression or end of study, an average of 1 year
Title
Progression free survival (PFS).
Time Frame
From first dose to disease progression or end of study, an average of 1 year
Title
Overall survival (OS).
Time Frame
From first dose to death or end of study, an average of 1 year
Title
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
Time Frame
From enrollment until 30 days after the last dose
Title
Maximum measured plasma concentration (Cmax) of JMT101.
Time Frame
From enrollment until 30 days after the last dose
Title
Time to maximum plasma concentration (Tmax) of JMT101.
Time Frame
From enrollment until 30 days after the last dose
Title
Half-life (T1/2) of JMT101.
Time Frame
From enrollment until 30 days after the last dose
Title
Immunogenicity profile of JMT101.
Description
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Time Frame
From enrollment until 30 days after the last dose
Title
Potential biomarkers detected in plasma circulating tumor DNA.
Time Frame
From enrollment up to disease progression, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically or cytologically confirmed, locally advanced or metastatic NSCLC, harboring an EGFR exon 20 insertion mutation. ( non-irradiable, non-operable); No previous treatment or first-line treatment failed NSCLC; At least 1 measurable lesion according to RECIST 1.1; ECOG score 0 or 1; Exclusion Criteria: Previously treated with EGFR antibody; Symptomatic brain metastasis; Interstitial pneumopathy; Known hypersensitivity to any ingredient of JMT101, afatinib, osimertinib or their excipients; Receiving an investigational product in another clinical study within 4 weeks; History of serious systemic diseases; History of serious autoimmune diseases; Pregnancy or lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiugao Yang
Phone
8021-60677906
Email
yangxiugao@mail.ecspc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Hu
Phone
8021-60673935
Email
hurong@mail.ecspc.com
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhang
Phone
8020-87343458
Email
zhangli@sysucc.org.cn
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Da Jiang
Phone
80311-86095588
Email
jiangda139@163.com
First Name & Middle Initial & Last Name & Degree
Mingxia Wang
Phone
80311-66696233
Email
hb4thgcp@126.com
Facility Name
Chinese Pla General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Hu
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Wu
Facility Name
West China Hospital of Sichuan University
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Luo
Facility Name
Fujian Cancer Hospital
City
Fuzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Zhuang
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiping Zhang
Facility Name
Jiangsu Province Hospital of Chinese Medicine
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Wang
Facility Name
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liyun Miao
Facility Name
Shanghai Chest Hospital, Shanghai Jiaotong University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baohui Han
Facility Name
Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junping Zhang
Facility Name
Shanxi Province Cancer Hospital
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Guo
Facility Name
Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaorong Dong

12. IPD Sharing Statement

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Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer

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