Advanced Solid Tumors
Conditions
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.
Interventions
DRUGIBI321
Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures. 2. Patients with advanced solid tumors who had failed standard treatment. 3. Male or female subjects ≥18 years and ≤75 years. 4. At least one measurable lesion per RECIST version 1.1 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 6. Life expectancy of ≥ 12 weeks. 7. Adequate hematologic and end organ function
Exclusion criteria
1. Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy. 2. Failure to recover from adverse events from the most recent anti-tumor treatment 3. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection. 4. 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. 5. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Dose-Limiting Toxicities (DLTs) | From Day 1 of Cycle 1 to Day 28 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Concentration-Time Curve (AUC) of IBI321 | From Day 1 up to 2 years |
| Maximum Serum Concentration (Cmax) of IBI321 | From Day 1 up to 2 years |
| Minimum Serum Concentration (Cmin) of IBI321 | From Day 1 up to 2 years |
| Clearance (CL) of 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) |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) and Neutralizing Antibody (Nab) to IBI321 | From Day 1 up to 2 years |
| 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) |
Countries
China
Outcome results
None listed