Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04689100
• Other study ID #: JMT101-ECL
• Status: Recruiting
• Phase: Phase 1
• Start date: April 11, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2020
• Source: Shanghai JMT-Bio Inc.
• Contact: Xiugao Yang
• Phone: 8021-60677906
• Email: yangxiugao[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 259
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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)
• JMT101
IV infusion Q2W (28-day cycles)

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai JMT-Bio Inc.	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE V4.03)).		From enrollment until 30 days after the last dose
Primary	Number of Subjects Experiencing DLTs (Dose Limiting Toxicity).		Time from the first dose of study drug up to 4 weeks
Primary	Maximum Tolerated Dose (MTD)		28 days
Secondary	Objective Response Rate (ORR)		From first dose to disease progression or end of study, an average of 1 year
Secondary	Disease control rate (DCR).		From first dose to disease progression or end of study, an average of 1 year
Secondary	Progression free survival (PFS).		From first dose to disease progression or end of study, an average of 1 year
Secondary	Overall survival (OS).		From first dose to death or end of study, an average of 1 year
Secondary	Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.		From enrollment until 30 days after the last dose
Secondary	Maximum measured plasma concentration (Cmax) of JMT101.		From enrollment until 30 days after the last dose
Secondary	Time to maximum plasma concentration (Tmax) of JMT101.		From enrollment until 30 days after the last dose
Secondary	Half-life (T1/2) of JMT101.		From enrollment until 30 days after the last dose
Secondary	Immunogenicity profile of JMT101.	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).	From enrollment until 30 days after the last dose
Secondary	Potential biomarkers detected in plasma or tumor issue DNA.	The content of RAS(reticular activating system), EGFR(epidermal growth factor receptor), BRAF(B-Raf proto-oncogene) gene will be detected.	From enrollment up to disease progression, an average of 1 year