The primary objective of this phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or its Combination Therapies in Patients with Advanced Malignancies
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
IBI397 single-agent dose escalation: Subjects will receive IBI397 until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
IBI397 in combination with sintilimab: Subjects will receive IBI397 combination therapy with sintilimab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
IBI397 in combination with rituximab: Subjects will receive IBI397 combination therapy with rituximab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Number of patients with treatment related AEs
Number of patients who experienced a treatment related AEs from the frist dose until 90 days after the last dose
Time frame: Up to 90 days post last dose
Percentage of Subjects with Dose-Limiting Toxicities (DLTs)
To evaluate the safety and tolerability of IBI397 alone or in combination with Sintilimab
Time frame: Up to 28 Days following first dose
area under the plasma concentration-time curve (AUC)
Time frame: Up to 90 days post last dose
maximum concentration (Cmax)
Time frame: Up to 90 days post last dose
clearance (CL)
Time frame: Up to 90 days post last dose
volume of distribution (V)
Time frame: Up to 90 days post last dose
half-life (t1/2)
Time frame: Up to 90 days post last dose
anti-drug antibody (ADA)
Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI397
Time frame: Up to 90 days post last dose
Objective response rate (ORR)
Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed per RECIST v1.1 criteria for solid tumors or per Lugano2014 criteria for lymphomas
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Time frame: Up to 2 years after enrollment