NCT03792958

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: AnewPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	CM082	CM082 tablets taken orally 200、400、600 and 800 mg (QD or BID)

Timeline

• Start date: 2019-02-26
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2019-01-04
• Last updated: 2022-11-14

Locations

1 site across 1 country: China