Advanced Solid Tumors
Conditions
Brief summary
This is open-label, multicenter, Phase Ib study is designed to evaluate the Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in participants with advanced solid tumors.
Interventions
DRUGIBI321
IBI321 at a dose no higher than RP2D, D1 IV Q3W.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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. Male or female subjects ≥18 years and ≤75 years. 3. At least one measurable lesion per RECIST version 1.1 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 5. Life expectancy of ≥ 12 weeks. 6. Adequate hematologic and end organ function
Exclusion criteria
1. Failure to recover from adverse events from the most recent anti-tumor treatments 2. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection. 3. 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. 4. 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 |
|---|---|
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators. | From Baseline until disease progression (up to 2 years) |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | From Day 1 to up to 2 years |
| Percentage of Participants with Adverse Events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 | From Day 1 to up to 2 years |
| 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 |
| Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators. | From Baseline until disease progression (up to 2 years) |
| Clearance (CL) of IBI321 | From Day 1 up to 2 years |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to IBI321 | From Day 1 up to 2 years |
| Percentage of Participants with Neutralizing Antibody (Nab) to IBI321 | From Day 1 up to 2 years |
| Minimum Serum Concentration (Cmin) of IBI321 | From Day 1 up to 2 years |
Countries
China
Contacts
Primary ContactYang Wu
Outcome results
None listed