This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors
Phase Ia is dose escalation and dose expansion study of IBI360 monotherapy and IBI360 in combination with sintilimab in advanced or metastatic Solid Tumors; Phase Ib is an multi-cohort trial of pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors to evaluate safety and preliminary efSficacy of IBI360 in combination with sintilimab and (or) chemotherapy or IBI360 monotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
IBI 360 dose level of escalation IV Q3W Day 1
IBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1
Innovent Biologics (suzhou) Co. , Ltd.
Suzhou, Jiangsu, China
Safety and tolerance
Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)
Time frame: up to 90 days following last dose
Recommended Phase 2 Dose (RP2D)
A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data
Time frame: up to 21 days following last dose level
Efficacy
Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).
Time frame: Subjects were randomized 6 months and 1 year later
Pharmacokinetics
Area under plasma concentration vs time curve(AUC)
Time frame: Up to 48 weeks following first dose
Immunogenicity
Incidence of anti-drug antibodies (ADA) will be measured
Time frame: up to 90 days following last dose
Pharmacokinetics
Peak plasma concentration(Cmax)
Time frame: Up to 48 weeks following first dose
Pharmacokinetics
Up to 48 weeks following first dose
Time frame: Clearance(CL)
Pharmacokinetics
Apparent volumeof distribution(V)
Time frame: Up to 48 weeks following first dose
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Pharmacokinetics
Terminal Half Life(T1/2)
Time frame: Up to 48 weeks following first dose