IBI308 in Subjects With Advanced/Metastatic Solid Malignancies
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|ClinicalTrials.gov Identifier: NCT03568539|
Recruitment Status : Completed
First Posted : June 26, 2018
Results First Posted : June 1, 2021
Last Update Posted : June 1, 2021
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||Drug: IBI308||Phase 1|
|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|
|Actual Primary Completion Date :||November 9, 2020|
|Actual Study Completion Date :||December 7, 2020|
IBI308 200mg IV infusion, every 3 weeks.
- Overall Response Rate (Confirmed) [ Time Frame: 29 months ]
To evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Progression-free Survival [ Time Frame: 2 years ]To measure progression-free survival rate (PFS) 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
- 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)
- Number of Participants With Detectable Anti- Drug Antibodies. [ Time Frame: 2 years ]Anti-Drug Antibodies will be tested to evaluate immunogenicity of IBI308
- Area Under the Curve (AUC [0-504h]) [ Time Frame: 0-504h ]To evaluate the Area Under the Curve [AUC] of IBI308.
- Maximum Plasma Concentration [Cmax] [ Time Frame: Cycle 1 Day 1: predose, 5 minutes, 1, 6, 24, 48, 168, and 336 hr post-end of infusion ]To evaluate the Maximum Plasma Concentration [Cmax] 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|
|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|