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Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04689100
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : December 30, 2020
Sponsor:
Collaborator:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Information provided by (Responsible Party):
Shanghai JMT-Bio Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: JMT101 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 259 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
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Arm Intervention/treatment
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).

 Drug: JMT101
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 Name: FOLFIRI(Irinotecan, Leucovorin Calcium, and Fluorouracil); mFOLFOX6((Oxaliplatin, Leucovorin Calcium, and Fluorouracil);
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 (28-day cycles)
Other Name: FOLFIRI; mFOLFOX6; Irinotecan;


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Number of Subjects Experiencing DLTs (Dose Limiting Toxicity). [ Time Frame: Time from the first dose of study drug up to 4 weeks ]
  3. Maximum Tolerated Dose (MTD) [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From first dose to disease progression or end of study, an average of 1 year ]
  2. Disease control rate (DCR). [ Time Frame: From first dose to disease progression or end of study, an average of 1 year ]
  3. Progression free survival (PFS). [ Time Frame: From first dose to disease progression or end of study, an average of 1 year ]
  4. Overall survival (OS). [ Time Frame: From first dose to death or end of study, an average of 1 year ]
  5. 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 ]
  6. Maximum measured plasma concentration (Cmax) of JMT101. [ Time Frame: From enrollment until 30 days after the last dose ]
  7. Time to maximum plasma concentration (Tmax) of JMT101. [ Time Frame: From enrollment until 30 days after the last dose ]
  8. Half-life (T1/2) of JMT101. [ Time Frame: From enrollment until 30 days after the last dose ]
  9. 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).

  10. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04689100


Contacts
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Contact: Xiugao Yang 8021-60677906 yangxiugao@mail.ecspc.com
Contact: Rong Hu 8021-60673935 hurong@mail.ecspc.com

Locations
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China
Beijing Luhe Hospital. Capital Medical University Recruiting
Beijing, China
Contact: Dong Yan         
Peking University Cancer Hospital Recruiting
Beijing, China
Contact: Lin Shen    8010-88196561    linshenpku@163.com   
The first affiliated hospital of bengbu medical college Recruiting
Bengbu, China
Contact: Jun Qian         
Principal Investigator: Jun Qian         
Principal Investigator: Huan Zhou         
The First People's Hospital of Changzhou Recruiting
Changzhou, China
Contact: Wenwei Hu         
Chongqing University Cancer Hospital Recruiting
Chongqing, China
Contact: Weiqi Nian         
The Sixth Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, China
Contact: Yanhong Deng         
Zhongshan Hospital Recruiting
Shanghai, China
Contact: Tianshu Liu         
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, China
Contact: Weichang Chen         
Henan Cancer Hospital Not yet recruiting
Zhengzhou, China
Contact: Jufeng Wang         
Sponsors and Collaborators
Shanghai JMT-Bio Inc.
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Study Chair: Xiugao Yang Department of Medicine, CSPC Clinical Development Division
More Information
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Responsible Party: Shanghai JMT-Bio Inc.
ClinicalTrials.gov Identifier: NCT04689100    
Other Study ID Numbers: JMT101-ECL
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Leucovorin
Fluorouracil
Oxaliplatin
Irinotecan
Calcium
Levoleucovorin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
 Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients