Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFortvita Biologics (USA)Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;
Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors which have received available standard therapies and have disease progression, or unacceptable toxic effects, or contraindications;
At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;
Disqualifiers
Previous treatment with CEACAM5-targeted therapy;
Prior anti-cancer therapy within the wash-out period;
Received live vaccines within 4 weeks or cancer vaccine within 3 months;
Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;
Trial design
Design model
Sequential
Treatments tested in this trial
IBI3020
DrugRecombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection
Treatment groups
285 Participants
are divided into 1 treatment groupGroup A: IBI3020Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 years2
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 years3
Number of subjects with clinically significant changes in electrocardiogram
Clinically significant abnormal electrocardiogram findings reported by the investigator.
Time frame
Up to 3 years4
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 yearsSecondary outcomes
1
area under the curve (AUC)
area under the curve (AUC) of single and multiple doses of IBI3020
Time frame
Up to 3 years2
maximum concentration (Cmax)
maximum concentration (Cmax) of single and multiple doses of IBI3020
Time frame
Up to 3 years3
time to maximum concentration (Tmax)
time to maximum concentration (Tmax) of single and multiple doses of IBI3020
Time frame
Up to 3 years4
clearance (CL)
clearance (CL) of single and multiple doses of IBI3020
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fortvita Biologics (USA)Inc.
Lead sponsor
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Collaborator
Source ClinicalTrials.gov