This is a Phase 1/2, open-label, dose escalation and dose expansion study designed to characterize the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of IBB0979 in previously treated patients with locally advanced or metastatic solid tumors.
The study consists of Dose Escalation Phase, Dose Expansion Phase and Clinical Exploration Phase. Dose Escalation Phase:This phase is an open-label, non-randomized, multicenter, dose-escalation study. From the starting dose of 0.01 mg/kg, an accelerated titration combined with a "3+3" design will be adopted. Dose Expansion Phase:The application of Dose Expansion Phase can be discussed by investigator and sponsor based on data obtained in Dose Escalation Phase. This phase is an open-label, non-randomized, multicenter study. 6 patients with locally advanced or metastatic solid tumors are expected to be enrolled at DRDE. Each treatment cycle is defined as 21 days, patient may receive treatment until withdrawal or Treatment Discontinuation. Clinical Exploration Phase:After completing the dose escalation and expansion studies, the indication and study population can be discussed by the investigator and sponsor based on the efficacy and safety data that have been obtained.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
IBB0979 should be subcutaneous injected,qw
Shanghai East Hospital
Shanghai, Shanghai Municipality, 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: 21 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.
Time frame: Baseline through up to 1 years or until disease progression
Pharmacokinetic (PK) Cmax (Phase Ⅰ)
PK parameters (Cmax) following single dose.following single dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Cmin (Phase Ⅰ)
PK parameters (Cmin) following single dose.following single dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 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: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 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.
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Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 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.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) CL (Phase Ⅰ)
PK parameters (CL) following single dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Vd (Phase Ⅰ)
PK parameters (Vd) following single dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 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: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 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: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Css,max (Phase Ⅰ)
PK parameters (Css,max) following multiple dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Css,min (Phase Ⅰ)
PK parameters (Css,min) following multiple dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Css,av (Phase Ⅰ)
PK parameters (Css,av) following multiple dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUCss (Phase Ⅰ)
PK parameters (AUCss) following multiple dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) CLss (Phase Ⅰ)
PK parameters (CLss) following multiple dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Vss (Phase Ⅰ)
PK parameters (Vss) following multiple dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) R (Phase Ⅰ)
PK parameters (R) following multiple dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) DF (Phase Ⅰ)
PK parameters (DF) following multiple dose.
Time frame: Day1,2,3,4,6,8,11,14,17,21 of each subsequent cycle (each cycle is 21 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.
Time frame: Baseline through up to 1 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 IBB0979
The frequency of anti-drug antibodies (ADA) against IBB0979.(Phase Ⅰb)
Time frame: 3 months after end event visit
Progression free survival (PFS) (Phase Ⅱa)
PFS as assessed using RECIST 1.1.
Time frame: Baseline through up to 2 years or until disease progression
Overall survival (OS) (Phase Ⅱa)
OS as assessed using RECIST 1.1.
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.
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: Baseline through up to 2 years or until disease progression
Immunogenicity of IBB0979 (Phase Ⅱa)
The frequency of anti-drug antibodies (ADA) against IBB09798.(Phase Ⅱa)
Time frame: Baseline through up to 2 years or until disease progression