IBI308 in Subjects With Advanced/Metastatic Solid Malignancies
|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: NCT03568539|
Recruitment Status : Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : November 5, 2019
The study is to evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies.
Patients will be recruited for 2 cohorts:
• Cohort 1: Advanced/metastatic cancers with TMB>10 mutations per megabase (mut/Mb). This enrollment of this cohort has been stopped per sponsor's communication with the sites. For patients who have already enrolled in this cohort, treatment and monitoring will be conducted as stipulated by the protocol. The patients will remain on study until disease progression or intolerable toxicity, death, withdrawal of consent, or end of study, whichever occurs first.
Cohort 2: Advanced/metastatic endometrial cancer (N=40)
|Condition or disease||Intervention/treatment||Phase|
|Advanced/Metastatic Solid Malignancies||Biological: IBI308||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Phase 1b Multicenter Study of IBI308 in Subjects With Advanced/Metastatic Solid Malignancies|
|Actual Study Start Date :||June 27, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||August 2022|
IBI308 200mg IV infusion, every 3 weeks.
- Overall Response Rate [ Time Frame: 2 years ]
To evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies.
ORR includes CR and PR assessed by iRECIST v1.1 criteria.
- Progression-free survival [ Time Frame: 2 years ]To measure progression-free survival rate (PFS)
- Duration of response [ Time Frame: 2 years ]To measure duration of response (DOR)
- Overall survival [ Time Frame: 2 years ]To measure overall survival rate (OS)
- Immunogenicity [ Time Frame: Up to 2 years. ]Anti-Drug Antibodies will be tested to evaluate immunogenicity of IBI308
- Maximum Plasma Concentration [Cmax] [ Time Frame: Till 30 days after the last dose of IP. Up to 2 years. ]To evaluate the Maximum Plasma Concentration [Cmax] of IBI308.
- Area Under the Curve [AUC] [ Time Frame: Till 30 days after the last dose of IP. Up to 2 years. ]To evaluate the Area Under the Curve [AUC] of IBI308.
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): NCT03568539
|United States, California|
|UC Irvine Medical Center|
|Orange, California, United States, 92868|
|United States, Georgia|
|Northside Hospital, Inc|
|Atlanta, Georgia, United States, 30342|
|United States, Michigan|
|Henry Ford Medical Center|
|Detroit, Michigan, United States, 48202|
|United States, Nevada|
|Comprehensive Cancer Centers of Nevada|
|Las Vegas, Nevada, United States, 89169|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|White Plains Hospital Center for Cancer Care|
|White Plains, New York, United States, 10601|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Texas|
|Mary Crowley Cancer Research|
|Dallas, Texas, United States, 75230|