Clinical trial NCT04689100: Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor
Official title: A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
Collaborators: name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
First posted: 2020-12-30
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 escalation study, and Stage II was a dose expansion study.

Eligibility 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

Primary outcomes:
measure: Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE V4.03)).
timeFrame: From enrollment until 30 days after the last dose
measure: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity).
timeFrame: Time from the first dose of study drug up to 4 weeks
measure: Maximum Tolerated Dose (MTD)
timeFrame: 28 days
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From first dose to disease progression or end of study, an average of 1 year
measure: Disease control rate (DCR).
timeFrame: From first dose to disease progression or end of study, an average of 1 year
measure: Progression free survival (PFS).
timeFrame: From first dose to disease progression or end of study, an average of 1 year
measure: Overall survival (OS).
timeFrame: From first dose to death or end of study, an average of 1 year
measure: Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
timeFrame: From enrollment until 30 days after the last dose
measure: Maximum measured plasma concentration (Cmax) of JMT101.
timeFrame: From enrollment until 30 days after the last dose
measure: Time to maximum plasma concentration (Tmax) of JMT101.
timeFrame: From enrollment until 30 days after the last dose
measure: Half-life (T1/2) of JMT101.
timeFrame: From enrollment until 30 days after the last dose
measure: Immunogenicity profile of JMT101.
timeFrame: From enrollment until 30 days after the last dose
measure: Potential biomarkers detected in plasma or tumor issue DNA.
timeFrame: From enrollment up to disease progression, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe Hospital. Capital Medical University
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Bengbu
country: China
facility: The first affiliated hospital of bengbu medical college
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
affiliation: Department of Medicine, CSPC Clinical Development Division
name: Xiugao Yang
role: STUDY_CHAIR
References: