Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose of the study drug（ antiviral medication for hepatitis B and hepatitis C infection that are compliant with the protocol were allowed）;
Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive);
Acute or chronic active hepatitis B (HbsAg positive and/or HbcAb positive with HBV DNA titer ≥ 104 copies/mL or ≥ 2000 IU/mL or higher than lower limit of detection) or C (HCV Ab positive with HCV RNA titer > 103 copies/mL or higher than lower limit of detection);
Active COVID-19 infection with obvious symptoms requiring treatment or hospitalization, such as pyrexia, dyspnea, nausea, vomiting, diarrhea, etc.;
Trial design
Design model
Sequential
Treatments tested in this trial
IBI3005
DrugBispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)
Treatment groups
198 Participants
are divided into 1 treatment groupGroup A: IBI3005Experimental 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 vital signs
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Time frame
Up to 3 years4
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
Time frame
Up to 4 weeksSecondary outcomes
1
area under the curve (AUC)
area under the curve (AUC) of single and multiple doses of IBI3005
Time frame
up to 3 years2
maximum concentration (Cmax)
maximum concentration (Cmax) of single and multiple doses of IBI3005
Time frame
up to 3 years3
time to maximum concentration (Tmax)
time to maximum concentration (Tmax) of single and multiple doses of IBI3005
Time frame
up to 3 years4
clearance (CL)
clearance (CL) of single and multiple doses of IBI3005
Time frame
up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov