This is a Phase 1, open-label, dose-escalation and cohort expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IMM2510(Anti-PD-L1 and VEGF trap recombinant protein) combine with IMM01(Anti-CD47 Recombinant Protein) in patients with advanced solid tumors who have received at least first line treatment in past.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
104
IMM2510 administered intravenously once every 2 weeks (Q2W). Dose escalation cohorts will receive ascending doses of IMM2510 (e.g., 10 mg/kg, 20 mg/kg, up to maximum tolerated dose or recommended phase 2 dose).
IMM01 administered intravenously once every 2 weeks (Q2W). Dose escalation cohorts will receive ascending doses of IMM01 (e.g., 1 mg/kg, 2 mg/kg, 3mg/kg, up to maximum tolerated dose or recommended phase 2 dose).
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, China
DLT/MTD (Dose Escalation Phase)
Time frame: Within 28 days after the investigational products administration (within 56 days after first dosing of C1D1)
Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0)
Time frame: From the first dose to 30 days after the last dose [90 days for SAEs and Immune-related Adverse Event (irAEs) ], or until beginning new anti-tumor treatment
Objective Response Rate (ORR)
Time frame: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.
RP2D (Dose Extension Phase)
Time frame: From the first dose until disease progresses or end of treatment for other reasons, the maximum treatment duration is not more than 96 weeks
Disease Control Rate(DCR)
Time frame: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.
Duration of Response (DOR)
Time frame: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.
progression- free survival(PFS)
Time frame: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.
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overall survival（OS）
Time frame: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.
Cmax
Peak concentration (Cmax)
Time frame: Up to approximately 1 year
Tmax
Peak time (Tmax)
Time frame: Up to approximately 1 year
AUC0-tlast
Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t)
Time frame: Up to approximately 1 year
AUC0-inf
Area under plasma concentration-time curve from 0 to infinite time
Time frame: Up to approximately 1 year
t1/2
Elimination phase half-life (t1/2), in single dose period.
Time frame: Up to approximately 1 year
CL
Clearance Rate
Time frame: Up to approximately 1 year