This is a Phase I/IIa Clinical Trial to Evaluate the Safety,Tolerability,Pharmacokinetics and Preliminary Effectiveness of IAE0972 in Patients With Advanced Malignant Solid 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 finishing the Phase 1a dose escalation, the Phase Ib dose extension study can be carried out in the MTD dose which is obtained from Phase 1a . After Phase Ia \&1b are 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
120
IAE0972 is an investigational product
Affilated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
NOT_YET_RECRUITINGShanghai East Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGTo evaluate the safety and tolerability of IAE0972 in Phase I
MTD/R2PD ,Incidence and frequency of DTL; AE,SAE occurrence and frequency (according to NCI CTCAE 5.0)
Time frame: 28 days after last medication, an average of 1 year
Objective response rate (ORR) in Phase IIa
To explore the effectiveness of IAE0972.
Time frame: Baeline until disease progression, assessed up to 36 months
Pharmacokinetic (PK) Cmax
PK parameters Cmax following single dose
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) Css,max
PK parameters Css,max following multiple doses
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Css,min
PK parameters Css,min following multiple doses
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Css,av
PK parameters Css,av following multiple doses
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) AUCss
PK parameters AUCss following multiple doses
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) CLss
PK parameters CLss following multiple doses
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Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Vss
PK parameters Vss following multiple doses
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) R
PK parameters R following multiple doses
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) DF
PK parameters DF following multiple doses
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Cmin
PK parameters Cmin following single dose
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) Tmax
PK parameters Tmax following single dose
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) AUC0-t
PK parameters AUC0-t following single dose
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) AUC0-∞
PK parameters AUC0-∞ following single dose
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) CL
PK parameters CL following single dose
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) Vd
PK parameters Vd following single dose
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) t1/2
PK parameters t1/2 following single dose
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) λz
PK parameters λz following single dose
Time frame: after single dose , an average of 1 year
Objective response rate (ORR) (Phase I )
To explore the preliminary effectiveness of IAE0972.
Time frame: Baeline until disease progression or death, an average of 1 year
Overall survival (OS) (Phase I )
To explore the preliminary effectiveness of IAE0972.
Time frame: Baeline until disease progression or death, an average of 1 year
Disease control rate (DCR) (Phase I )
To explore the preliminary effectiveness of IAE0972.
Time frame: Baeline until disease progression or death, an average of 1 year
To evaluate the Immunogenicity of IAE0972 in patients with advanced malignant solid tumors (Phase I )
The frequency of anti-drug antibodies(ADA) against IAE0972
Time frame: Before each administration of dose cycle,an average of 1 year
Progression-free survival(PFS) in Phase II
To explore the effectiveness of IAE0972.
Time frame: Baeline until disease progression or death,assessed up to 36 months
Overall survival (OS)in Phase II
To explore the effectiveness of IAE0972.
Time frame: Baeline until disease progression or death,assessed up to 36 months
Disease control rate (DCR) in Phase II
To explore the effectiveness of IAE0972.
Time frame: Baeline until disease progression or death,assessed up to 36 months
Immunogenicity of IAE0972 (Phase II )
The frequency of anti-drug antibodies(ADA) against IAE0972
Time frame: Before each administration of dose cycle,assessed up to 36 months
Incidence of adverse event (AEs) and SAEs (Phase II)
To investigate the safety characteristics
Time frame: After last medication,assessed up to 36 months