Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor
NCT ID: NCT04689100
Last Updated: 2020-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
259 participants
INTERVENTIONAL
2017-04-11
2022-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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).
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)
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.
JMT101
IV infusion Q2W (28-day cycles)
Interventions
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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)
JMT101
IV infusion Q2W (28-day cycles)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
INDUSTRY
Shanghai JMT-Bio Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiugao Yang
Role: STUDY_CHAIR
Department of Medicine, CSPC Clinical Development Division
Locations
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Beijing Luhe Hospital. Capital Medical University
Beijing, , China
Peking University Cancer Hospital
Beijing, , China
The first affiliated hospital of bengbu medical college
Bengbu, , China
The First People's Hospital of Changzhou
Changzhou, , China
Chongqing University Cancer Hospital
Chongqing, , China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, , China
Zhongshan Hospital
Shanghai, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Dong Yan
Role: primary
Lin Shen
Role: primary
Jun Qian
Role: primary
Wenwei Hu
Role: primary
Weiqi Nian
Role: primary
Yanhong Deng
Role: primary
Tianshu Liu
Role: primary
Weichang Chen
Role: primary
Jufeng Wang
Role: primary
Other Identifiers
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JMT101-ECL
Identifier Type: -
Identifier Source: org_study_id