A Study of IBI363 in Subjects With Advanced Malignancies
ConditionAdvanced Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
This is an open-label, multicenter Phase Ib study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced malignancies patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sign written informed consent and be able to comply with the program's visit schedule and related procedures.
Male or female subjects, age 18~75 years.
Histologically or cytologically confirmed advanced malignancy.
Subjects who have progressed on standard therapy, who are unsuitable for standard therapy, who do not have standard therapy, or who have refused standard therapy. For particular cohort, subjects who have not received prior systemic therapy for advanced disease.
Disqualifiers
Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
Active or untreated CNS metastases confirmed by imaging evaluation during screening or previous imaging evaluation. Patients with asymptomatic brain metastases may participate in this study.
History of active thrombosis or deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study drug.
Clinically significant cardiovascular or cerebrovascular disease.
Trial design
Design model
Parallel
Treatments tested in this trial
IBI363 + chemotherapy
DrugIn this group, patients will receive IBI363 and chemotherapy
IBI363 + Investigator's Choice SOC
DrugIn this group, patients will receive IBI363 and Investigator's Choice SOC
Treatment groups
556 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2AExperimental treatment 1 intervention
Group C: Cohort 2BExperimental treatment 1 intervention
Group D: Cohort 3Experimental treatment 1 intervention
Group E: Cohort 4Experimental treatment 1 intervention
Group F: Cohort 5Experimental treatment 1 intervention
Group G: Cohort 6Experimental treatment 1 intervention
Group H: Cohort 7Experimental treatment 1 intervention
Group I: Cohort 8Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Enent (AE)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame
Up to 90 days after the last administration2
Treatment-Emergent AE (TEAE)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame
Up to 90 days after the last administration3
Adverse Event of Special Interest (AESI)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame
Up to 90 days after the last administration4
Serious Adverse Event (SAE)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame
Up to 90 days after the last administrationSecondary outcomes
1
Plasma concentration (Cmax) of IBI363
PK parameters maximum concentration (Cmax) of IBI363
Time frame
Up to 2 years2
Area under the curve (AUC) of IBI363
PK parameters area under the curve (AUC)?of IBI363
Time frame
Up to 2 years3
Half-life (T1/2) of IBI363
PK parameters half-life (t1/2)?of IBI363
Time frame
Up to 2 years4
Clearance (CL) of IBI363
PK parameters clearance rate of IBI363
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov