A Phase I Study of RC88-ADC in Subjects With 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04175847|
Recruitment Status : Not yet recruiting
First Posted : November 25, 2019
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: RC88||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Evaluate the Safety, Pharmacokinetics and Effect of RC88-ADC For Injection in Subjects With Advanced Malignant Solid Tumors|
|Estimated Study Start Date :||February 15, 2020|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||May 31, 2022|
Participants will be allocated to one of the following dose groups: 0.1, 0.5, 1.0, 1.5, 2.0 and 2.5 mg/kg, and receive a treatment of RC88-ADC followed by 21 days of dose limited toxicity (DLT) observation period.
Other Name: RC88 for Injection
- Adverse events [ Time Frame: From the day of ICF sign to 28 days after the day of the last treatment ]Adverse events was assessed by investigator(s) according to NCI-CTCAE v4.03
- Maximum Tolerated dose of RC88 [ Time Frame: 21 days after first treatment. ]The dose level in which >= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level.
- Objective Response Rate (ORR) [ Time Frame: 24 months ]Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
- Progression Free Survival (PFS) [ Time Frame: 24 months ]Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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): NCT04175847
|Contact: Jianmin Fangfirstname.lastname@example.org|
|National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College|
|Beijing, Beijing, China, 100021|
|Contact: Yuankai Shi, M.D.|