A Phase 1 Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT03717103|
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : December 19, 2018
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy in patients with advanced malignancies.
The study is composed of Ia and Ib phases.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignancies||Drug: IBI188 Drug: IBI188, Rituximab||Phase 1|
Phase Ia study is composed of two stages: Phase Ia Part A initial dose escalation and Phase Ia Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.
The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 2 dose cohorts (0.3 mg/kg QW and 1 mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.
Phase Ia Part B will have 4 dose cohorts(3mg/kg QW、10mg/kg QW、20mg/kg QW and 30mg/kg QW). DLT observation period is 28 days. The subject number for each cohort in Phase Ia Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.
Dose level for Phase Ib study will be determined based on the recommended dose from phase Ia.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignancies|
|Actual Study Start Date :||December 11, 2018|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||January 31, 2022|
0.1 mg/kg IV QW 0.3 mg/kg IV QW
1 mg/kg IV QW
Other Name: Phase Ia Part A : Initial dose escalation
3 mg/kg IV QW 10 mg/kg IV QW 20 mg/kg IV QW 30 mg/kg IV QW
Other Name: Phase Ia Part B : Maintenance dose escalation
Drug: IBI188, Rituximab
Recommended dose from Ia
Other Name: Phase Ib
- Adverse events (AEs), Serious Adverse Events (SAE) [ Time Frame: 2 years ]Number of patients with AEs and SAEs
- Overall Response Rate (ORR） [ Time Frame: up to 2 years after enrollment ]
To evaluate preliminary anti-tumor activity of IBI188 in subjects with advanced malignancies.
ORR includes CR and PR assessed by iRECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma.
- Disease Control Rate (DCR) [ Time Frame: up to 2 years after enrollment ]To evaluate preliminary anti-tumor activity of IBI188 in subjects with advanced malignancies.
- Pharmacokinetics：AUC [ Time Frame: up to 2 years after enrollment ]The area under the curve (AUC) of serum concentration of the drug after the administration
- Pharmacokinetics: Cmax [ Time Frame: up to 2 years after enrollment ]Maximum concentration(Cmax) of the drug after administration
- Immunogenicity [ Time Frame: up to 2 years after enrollment ]Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of IBI188.
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): NCT03717103
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100142|
|Contact: Yuqin Song +861088196115 SongYQ_VIP@163.com|