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| Name | Class |
|---|---|
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Cohort | Experimental | 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). |
|
| Dose Expansion Cohort | Experimental | Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMT101 | Drug | 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) |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiugao Yang | Contact | 8021-60677906 | yangxiugao@mail.ecspc.com | |
| Rong Hu | Contact | 8021-60673935 | hurong@mail.ecspc.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiugao Yang | Department of Medicine, CSPC Clinical Development Division | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Luhe Hospital. Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
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| JMT101 | Drug | IV infusion Q2W (28-day cycles) |
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| 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 |
| Maximum measured plasma concentration (Cmax) of JMT101. | From enrollment until 30 days after the last dose |
| 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 |
| 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 |
| 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 |
| Peking University Cancer Hospital | Recruiting | Beijing | China |
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| The first affiliated hospital of bengbu medical college | Recruiting | Bengbu | China |
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| The First People's Hospital of Changzhou | Recruiting | Changzhou | China |
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| Chongqing University Cancer Hospital | Recruiting | Chongqing | China |
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| The Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | China |
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| Zhongshan Hospital | Recruiting | Shanghai | China |
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| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | China |
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| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002166 | Camptothecin |
| D000470 | Alkaloids |