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
Qualifiers
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
Treatments tested in this trial
- IBI363 + chemotherapy
- IBI363 + Investigator's Choice SOC
Treatment groups
556 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov