Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer
NCT ID: NCT04448379
Last Updated: 2020-12-28
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
48 participants
INTERVENTIONAL
2020-06-29
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
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).
JMT101
IV infusion Q2W for 4 weeks (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 for 4 weeks (28-day cycles)
Interventions
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JMT101
IV infusion Q2W for 4 weeks (28-day cycles)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
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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Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Chinese Pla General Hospital
Beijing, , China
Hunan Cancer Hospital
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
Fujian Cancer Hospital
Fuzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, , China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
Shanghai Chest Hospital, Shanghai Jiaotong University
Shanghai, , China
Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)
Taiyuan, , China
Shanxi Province Cancer Hospital
Taiyuan, , China
Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology
Wuhan, , China
Countries
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Central Contacts
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Facility Contacts
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Li Zhang
Role: primary
Da Jiang
Role: primary
Mingxia Wang
Role: backup
Yi Hu
Role: primary
Lin Wu
Role: primary
Feng Luo
Role: primary
Wu Zhuang
Role: primary
Yiping Zhang
Role: primary
Qian Wang
Role: primary
Liyun Miao
Role: primary
Baohui Han
Role: primary
Junping Zhang
Role: primary
Wei Guo
Role: primary
Xiaorong Dong
Role: primary
References
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Zhao S, Zhuang W, Han B, Song Z, Guo W, Luo F, Wu L, Hu Y, Wang H, Dong X, Jiang D, Wang M, Miao L, Wang Q, Zhang J, Fu Z, Huang Y, Xu C, Hu L, Li L, Hu R, Yang Y, Li M, Yang X, Zhang L, Huang Y, Fang W. Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer. Nat Commun. 2023 Jun 12;14(1):3468. doi: 10.1038/s41467-023-39139-4.
Other Identifiers
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JMT101-CSP-001
Identifier Type: -
Identifier Source: org_study_id