Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Malignant Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02881190|
Recruitment Status : Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: RC48-ADC||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Tolerance, Safety and Pharmacokinetic Ascending Dose Phase I Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive Malignant in Advanced Malignant Solid Tumors|
|Actual Study Start Date :||November 14, 2015|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2019|
The phase I component has several dose levels of RC48-ADC (0.1mg/kg，0.5 mg/kg, 1.0mg/kg, 1.5mg/kg, 2.0mg/kg, 2.5mg/kg, 3.0mg/kg, 3.5mg/kg and 4.0 mg/kg) and is designed as a traditional dose-escalation study.Dosing interval is once two weeks.
- Maximal Tolerance Dose (MTD) of RC48-ADC [ Time Frame: DLT will be evaluated on Day 28 during cycle 1 ]The dose level in which >= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level.
- Safety (the drug safety as assessed by NCI-CTCAE v4.0) [ Time Frame: up to 2 years ]The drug safety as assessed by NCI-CTCAE v4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881190
|Beijing Cancer Hospital|
|Beijing, Beijing, China, 100142|
|Principal Investigator:||Lin Shen||Beijing Cancer Hospital|