A Study of the Safety and Tolerability of IBI321 in Patients With Advanced Solid Tumors
- Registration Number
- NCT04911881
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Brief Summary
This first-in-human open-label,dose-escalation study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- Patients with advanced solid tumors who had failed standard treatment.
- Male or female subjects ≥18 years and ≤75 years.
- At least one measurable lesion per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
- Life expectancy of ≥ 12 weeks.
- Adequate hematologic and end organ function
Exclusion Criteria
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.
- Failure to recover from adverse events from the most recent anti-tumor treatment
- Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
- Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
- Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
- Pregnancy, lactation, breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase Ia Dose-Escalation Stage: IBI321 IBI321 -
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE) and serious adverse event (SAE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 ; From Day 1 to up to 2 years Percentage of Participants with Dose-Limiting Toxicities (DLTs) From Day 1 of Cycle 1 to Day 28
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR)per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. From Baseline until disease progression (up to 2 years) Overall Survival (OS) From Baseline until disease progression (up to 2 years) Percentage of Participants with Anti-Drug Antibodies (ADAs) and Neutralizing Antibody (Nab) to IBI321 From Day 1 up to 2 years Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. From Baseline until disease progression (up to 2 years) Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. From Baseline until disease progression (up to 2 years) Maximum Serum Concentration (Cmax) of IBI321 From Day 1 up to 2 years Clearance (CL) of IBI321 From Day 1 up to 2 years Area Under the Concentration-Time Curve (AUC) of IBI321 From Day 1 up to 2 years Minimum Serum Concentration (Cmin) of IBI321 From Day 1 up to 2 years
Trial Locations
- Locations (1)
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China