A Phase 1, Multicenter, Open-label Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
Summary
The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.
Arms & interventions
- DrugIBI3020
Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection
Outcome measures
Primary
Numbers of subjects with adverse events
defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Time frame: Up to 3 years
Number of subjects with clinically significant changes in physical examination results
Clinically significant abnormal physical examination findings reported by the investigator.
Time frame: Up to 3 years
Number of subjects with clinically significant changes in electrocardiogram
Clinically significant abnormal electrocardiogram findings reported by the investigator.
Time frame: Up to 3 years
Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate, oxygen saturation by pulse oximetry at rest and blood pressure
Time frame: Up to 3 years
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
Time frame: Up to 21 days
objective response rate (ORR)
objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
Time frame: Up to 3 years
Number of subjects with clinically significant changes in laboratory parameters
Clinically significant abnormal laboratory parameters findings reported by the investigator.
Time frame: Up to 3 years
Secondary
area under the curve (AUC)
Time frame: Up to 3 years
maximum concentration (Cmax)
Time frame: Up to 3 years
time to maximum concentration (Tmax)
Time frame: Up to 3 years
clearance (CL)
Time frame: Up to 3 years
apparent volume of distribution (V)
Time frame: Up to 3 years
half-life (t1/2)
Time frame: Up to 3 years
anti-drug antibody (ADA)
Time frame: Up to 3 years
objective response rate (ORR)
Time frame: Up to 3 years
duration of response (DoR)
Time frame: Up to 3 years
time to response (TTR)
Time frame: Up to 3 years
progression free survival (PFS)
Time frame: Up to 3 years
disease control rate (DCR)
Time frame: Up to 3 years
overall survival (OS)
Time frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months
Eligibility criteria
Study locations (6)
Mayo Clinic - Arizona
Pheonix, Arizona, 85054
Mayo Clinic - Florida
Jacksonville, Florida, 32224
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Montefiore Cancer Center
New York, New York, 10461
NEXT Houston
Houston, Texas, 77054
NEXT Dallas
Irving, Texas, 75039