This is a phase I/IIa study to evaluate the safety, tolerability and efficacy of IBC0966 for the treatment of subjects with advanced malignant tumors.
The study includes three phases: dose escalation (Phase Ia), dose extension (Phase Ib), and clinical exploration (Phase IIa). First, the Phase Ia dose escalation will be carried out. After switching to the 3+3 escalation mode, the Phase Ib dose extension study can be carried out at the same time. After Phase Ia is completed and RP2D is obtained, Phase IIa clinical exploratory research can be carried out.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
228
IBC0966 is an investigational product.
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGFrequency of adverse events (AEs) and SAEs (Phase Ⅰ)
To investigate the safety characteristics.
Time frame: 3 months after end event visit
Dose limiting toxicities (DLTs) (Phase Ⅰ)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
Time frame: 28 days after first dose
Objective response rate (ORR) in dose expansion (Phase Ⅱa)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1 or Lugano 2014.
Time frame: Baseline through up to 2 years or until disease progression
Pharmacokinetic (PK) Cmax (Phase Ⅰ)
PK parameters (Cmax) following single dose.
Time frame: Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Tmax (Phase Ⅰ)
PK parameters (Tmax) following single dose.
Time frame: Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUC 0-t (Phase Ⅰ)
PK parameters (AUC 0-t ) following single dose.
Time frame: Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUC 0-∞ (Phase Ⅰ)
PK parameters (AUC 0-∞) following single dose.
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Time frame: Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) t1/2 (Phase Ⅰ)
PK parameters (t1/2) following single dose.
Time frame: Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) λz (Phase Ⅰ)
PK parameters (λz) following single dose.
Time frame: Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Css,max (Phase Ⅰ)
PK parameters (Css,max) following single dose.
Time frame: Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Css,min (Phase Ⅰ)
PK parameters (Css,min) following single dose.
Time frame: Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUCss (Phase Ⅰ)
PK parameters (AUCss) following single dose.
Time frame: Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years
Objective response rate (ORR) in dose escalation (Phase Ⅰ)
Tumor response based on RECIST 1.1 or Lugano 2014.
Time frame: Baseline through up to 2 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase Ⅰ)
To investigate the safety characteristics.
Time frame: 3 months after end event visit
Immunogenicity of IBC0966 (Phase Ⅰ)
The frequency of anti-drug antibodies (ADA) against IBC0966.(Phase Ⅰ)
Time frame: 3 months after end event visit
Progression free survival (PFS) (Phase Ⅱa)
PFS as assessed using RECIST 1.1 or Lugano 2014.
Time frame: Baseline through up to 2 years or until disease progression
Overall survival (OS) (Phase Ⅱa)
OS as assessed using RECIST 1.1 or Lugano 2014.
Time frame: Baseline through up to 2 years or until disease progression
Disease control rate (DCR) (Phase Ⅱa)
DCR as assessed using RECIST 1.1 or Lugano 2014.
Time frame: Baseline through up to 2 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase Ⅱa)
To investigate the safety characteristics.
Time frame: 3 months after end event visit
Immunogenicity of IBC0966 (Phase Ⅱa)
The frequency of anti-drug antibodies (ADA) against IBC0966.(Phase Ⅱa)
Time frame: 3 months after end event visit