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

December 23, 2020 updated by: Shanghai JMT-Bio Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Chinese PLA General Hospital
      • Changsha, China
        • Recruiting
        • Hunan Cancer Hospital
      • Chengdu, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Feng Luo
      • Fuzhou, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Wu Zhuang
      • Hangzhou, China
        • Recruiting
        • Zhejiang Cancer Hospital
      • Nanjing, China
        • Recruiting
        • Jiangsu Province Hospital of Chinese Medicine
        • Contact:
          • Qian Wang
      • Nanjing, China
        • Recruiting
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
        • Contact:
          • Liyun Miao
      • Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital, Shanghai Jiaotong University
      • Taiyuan, China
        • Recruiting
        • Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)
        • Contact:
          • Junping Zhang
      • Taiyuan, China
        • Recruiting
        • Shanxi Province Cancer Hospital
      • Wuhan, China
        • Recruiting
        • Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology
        • Contact:
          • Xiaorong Dong
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation Cohort

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).
Drug: JMT101
IV infusion Q2W for 4 weeks (28-day cycles)
Other Names:
  • Afatinib or Osimertinib
Experimental: Dose Expansion Cohort
Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
Drug: JMT101
IV infusion Q2W for 4 weeks (28-day cycles)
Other Names:
  • Afatinib or Osimertinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment until 30 days after the last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From first dose to disease progression or end of study, an average of 1 year
Disease control rate (DCR).
Time Frame: From first dose to disease progression or end of study, an average of 1 year
From first dose to disease progression or end of study, an average of 1 year
Progression free survival (PFS).
Time Frame: From first dose to disease progression or end of study, an average of 1 year
From first dose to disease progression or end of study, an average of 1 year
Overall survival (OS).
Time Frame: From first dose to death or end of study, an average of 1 year
From first dose to death or end of study, an average of 1 year
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
From enrollment until 30 days after the last dose
Maximum measured plasma concentration (Cmax) of JMT101.
Time Frame: From enrollment until 30 days after the last dose
From enrollment until 30 days after the last dose
Time to maximum plasma concentration (Tmax) of JMT101.
Time Frame: From enrollment until 30 days after the last dose
From enrollment until 30 days after the last dose
Half-life (T1/2) of JMT101.
Time Frame: From enrollment until 30 days after the last dose
From enrollment until 30 days after the last dose
Immunogenicity profile of JMT101.
Time Frame: From enrollment until 30 days after the last dose
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
From enrollment until 30 days after the last dose
Potential biomarkers detected in plasma circulating tumor DNA.
Time Frame: From enrollment up to disease progression, an average of 1 year
From enrollment up to disease progression, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai JMT-Bio Inc.

Collaborators

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

December 28, 2020

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMT101-CSP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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