Peking University Cancer Hospital & Institute
Beijing, China
NCT Number: NCT04353830
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Eligibility Criteria:
Several dose levels will be evaluated for IBI939 administered as a single agent and in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI939 may receive combination treatment with Sintilimab or IBI939+ Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit.
IBI939: Several dose levels will be evaluated for IBI939 in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit.
Time frame: up to 2 years after enrollment
To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab [Adverse events (AEs), Serious Adverse Events (SAEs) ]
Time frame: From Baseline to the end of Cycle 1
To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab.
Time frame: up to 2 years after enrollment
The area under the curve (AUC) of serum concentration of the drug after the administration.
Time frame: up to 2 years after enrollment
Maximum concentration (Cmax) of the drug after administration
Time frame: up to 2 years after enrollment
Immunogenicity: Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI939.
Time frame: up to 2 years after enrollment
Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors.
Innovent Biologics (Suzhou) Co. Ltd.
Industry
A Phase 1a, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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