A Study of IBI363 in Subjects with Advanced Solid Malignancies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects 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 subjects ≥ 18 years old;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
Anticipated life expectancy of ≥ 3 months;
Disqualifiers
Inadequate bone marrow and organ function;
Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose
Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;
Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;
Trial design
Design model
Single group
Treatments tested in this trial
IBI363
DrugIBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Subjects will receive study medication until disease progression, toxicity intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any other reason that requires discontinuation of the study treatment, whichever occurs first.
Treatment groups
178 Participants
are divided into 1 treatment groupGroup A: IBI363Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
Time frame
up to 2 yearsSecondary outcomes
1
Adverse Event （AE）
Time frame
Up to 90 days post last dose2
Dose-limiting Toxicity （DLT）
Time frame
The DLT observation period is 35 days starting from the first day of cycle 1 (C1D1) for subjects assigned to 1000 μg/kg Q2W, while 28 days starting from the C1D1 for subjects assigned to 2000/3000/4000 μg/kg Q3W.Sponsors and contacts
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Source ClinicalTrials.gov