Spots Global Cancer Trial Database for Study of Challenge Meditech 082 (CM082) Tablets in Patients With Advanced Malignant Solid Tumors

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Trial Identification

Brief Title: Study of Challenge Meditech 082 (CM082) Tablets in Patients With Advanced Malignant Solid Tumors

Official Title: Phase I Study of CM082 Tablets in the Treatment of Advanced Malignant Solid Tumors: Safety, Tolerance and Pharmacokinetics

Study ID: NCT03792958

Conditions

Advanced Malignant Solid Tumors

Interventions

CM082

Study Description

Brief Summary: This is a Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Oral Dosing of CM082 tablets in Chinese Patients With Advanced Malignant Solid Tumors

Detailed Description: This is a single-center、open-label and non-controlled Phase 1 study which will be conducted in two parts: part A is the dose-escalation phase; part B is dose-expansion phase. The dose-escalation phase is guided by pharmacokinetics (PK) and safety, according to the standard 3+3 dose-escalation schema. CM082 tablets are taken orally with a starting dose of 200 mg and a subsequent dose of 400, 600 and 800 mg. The way of administration is as follows: QD or BID. The primary objective of this study is to determine the maximum tolerable dose (MTD)、characteristics of dose-limited toxicity (DLT) and pharmacokinetics (PK). Secondary objectives include safety、tolerability and preliminary efficacy