Advanced Solid Tumor
Conditions
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.
Interventions
DRUGJMT101
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)
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Shanghai JMT-Bio Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Maximum Tolerated Dose (MTD) | 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS). | 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 | — |
| 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 | — |
| 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). |
| Time to maximum plasma concentration (Tmax) 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 | — |
| 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. |
| Maximum measured plasma concentration (Cmax) of JMT101. | From enrollment until 30 days after the last dose | — |
| Objective Response Rate (ORR) | From first dose to disease progression or end of study, an average of 1 year | — |
| Disease control rate (DCR). | From first dose to disease progression or end of study, an average of 1 year | — |
Countries
China
Contacts
Primary ContactXiugao Yang
Backup ContactRong Hu
Outcome results
None listed