Status:
UNKNOWN
Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor
Lead Sponsor:
Shanghai JMT-Bio Inc.
Collaborating Sponsors:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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.
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 escalati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT04689100
Start Date
April 11 2017
End Date
June 30 2022
Last Update
December 30 2020
Active Locations (9)
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1
Beijing Luhe Hospital. Capital Medical University
Beijing, China
2
Peking University Cancer Hospital
Beijing, China
3
The first affiliated hospital of bengbu medical college
Bengbu, China
4
The First People's Hospital of Changzhou
Changzhou, China