Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor

December 25, 2020 updated by: Shanghai JMT-Bio Inc.

A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.

This study is a Phase I, open label, multi-center study of to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

The objective of the trial is to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.

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)

259

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 Contact

Study Contact Backup

Study Locations

      • Beijing, China
        • Recruiting
        • Peking University Cancer Hospital
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Luhe Hospital. Capital Medical University
      • Bengbu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Principal Investigator:
          • Jun Qian
        • Contact:
          • Jun Qian
        • Principal Investigator:
          • Huan Zhou
      • Changzhou, China
        • Recruiting
        • The First People's Hospital of Changzhou
        • Contact:
          • Wenwei Hu
      • Chongqing, China
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
          • Weiqi Nian
      • Guangzhou, China
        • Recruiting
        • The Sixth Affiliated Hospital, Sun Yat-sen University
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital
      • Suzhou, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Weichang Chen
      • Zhengzhou, China
        • Not yet recruiting
        • Henan Cancer Hospital

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:

  • Monotherapy: Pathologically or cytologically confirmed, advanced solid tumor, harboring RAS wild type; Combined with chemotherapy: Pathologically or cytologically confirmed, locally advanced /metastatic colorectal cancer, harboring RAS and BRAF V600E wild type.
  • At least 1 measurable lesion according to RECIST 1.1;
  • ECOG score 0 or 1;
  • Stable for more than 14 days of brain metastasis or spinal cord compression.

Exclusion Criteria:

  • Receipt of any EGFR inhibitors within 5 months prior to the first dose of study treatment.
  • The second primary malignant tumor was diagnosed within 5 years prior to the first dose of study treatment.
  • Known hypersensitivity to any ingredient of JMT101 or their excipients;
  • Major surgery within prior 4 weeks of first treatment.
  • Receiving an investigational product in another clinical study within 4 weeks;
  • History of serious systemic diseases;
  • Pregnancy or lactating wo

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 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.
Monotherapy: Accelerated titration method, IV infusion QW; Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles)
Other Names:
  • FOLFIRI(Irinotecan, Leucovorin Calcium, and Fluorouracil); mFOLFOX6((Oxaliplatin, Leucovorin Calcium, and Fluorouracil);
IV infusion Q2W (28-day cycles)
Other Names:
  • FOLFIRI; mFOLFOX6; Irinotecan;
Experimental: Dose Escalation Cohort

Monotherapy: Six dose levels of JMT101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.

Combined with chemotherapy: Three dose levels of JMT101 will be tested by a conventional 3 + 3 study design.

The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).

Monotherapy: Accelerated titration method, IV infusion QW; Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles)
Other Names:
  • FOLFIRI(Irinotecan, Leucovorin Calcium, and Fluorouracil); mFOLFOX6((Oxaliplatin, Leucovorin Calcium, and Fluorouracil);
IV infusion Q2W (28-day cycles)
Other Names:
  • FOLFIRI; mFOLFOX6; Irinotecan;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD)
Time Frame: 28 days
28 days
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE V4.03)).
Time Frame: From enrollment until 30 days after the last dose
From enrollment until 30 days after the last dose
Number of Subjects Experiencing DLTs (Dose Limiting Toxicity).
Time Frame: Time from the first dose of study drug up to 4 weeks
Time from the first dose of study drug up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Objective Response Rate (ORR)
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
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(ADA) and neutralizing antibodies by electrochemical luminescence(ECL).
From enrollment until 30 days after the last dose
Potential biomarkers detected in plasma or tumor issue DNA.
Time Frame: From enrollment up to disease progression, an average of 1 year
The content of RAS(reticular activating system), EGFR(epidermal growth factor receptor), BRAF(B-Raf proto-oncogene) gene will be detected.
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.

Investigators

  • Study Chair: Xiugao Yang, Department of Medicine, CSPC Clinical Development Division

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)

April 11, 2017

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 25, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 25, 2020

Last Verified

December 1, 2020

More Information

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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