Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor

Phase 1

• Conditions: Advanced Solid Tumor
• Interventions: Drug: JMT101

• Registration Number: NCT04689100
• Lead Sponsor: Shanghai JMT-Bio Inc.

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.

Study Timeline

• Study Start: 2017-04-11
• Status Verified: 2020-12
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-25
• Last Update Submitted: 2020-12-25
• Study First Posted: 2020-12-30
• Last Update Posted: 2020-12-30
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 259

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Expansion Cohort	JMT101	Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
Dose Escalation Cohort	JMT101	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).

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	28 days
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
Number of Subjects Experiencing DLTs (Dose Limiting Toxicity).	Time from the first dose of study drug up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR).	From first dose to disease progression or end of study, an average of 1 year
Overall survival (OS).	From first dose to death or end of study, an average of 1 year
Objective Response Rate (ORR)	From first dose to disease progression or end of study, an average of 1 year
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
Maximum measured plasma concentration (Cmax) of JMT101.	From enrollment until 30 days after the last dose
Half-life (T1/2) of JMT101.	From enrollment until 30 days after the last dose
Progression free survival (PFS).	From first dose to disease progression or end of study, an average of 1 year
Time to maximum plasma concentration (Tmax) of JMT101.	From enrollment until 30 days after the last dose
Immunogenicity profile of JMT101.	From enrollment until 30 days after the last dose	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).
Potential biomarkers detected in plasma or tumor issue DNA.	From enrollment up to disease progression, an average of 1 year	The content of RAS(reticular activating system), EGFR(epidermal growth factor receptor), BRAF(B-Raf proto-oncogene) gene will be detected.

Trial Locations

Locations (9)

Beijing Luhe Hospital. Capital Medical University; 🇨🇳 Beijing, China

The first affiliated hospital of bengbu medical college; 🇨🇳 Bengbu, China

Peking University Cancer Hospital; 🇨🇳 Beijing, 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