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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04911881
Other study ID # CIBI321A101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 24, 2021
Est. completion date February 23, 2023

Study information

Verified date February 2023
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 23, 2023
Est. primary completion date February 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 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. 6. Pregnancy, lactation, breastfeeding

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IBI321
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.

Locations

Country Name City State
China Shanghai Chest Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Dose-Limiting Toxicities (DLTs) From Day 1 of Cycle 1 to Day 28
Primary 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 Objective Response Rate (ORR)per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. From Baseline until disease progression (up to 2 years)
Secondary Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. From Baseline until disease progression (up to 2 years)
Secondary Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. From Baseline until disease progression (up to 2 years)
Secondary Overall Survival (OS) From Baseline until disease progression (up to 2 years)
Secondary Area Under the Concentration-Time Curve (AUC) of IBI321 From Day 1 up to 2 years
Secondary Maximum Serum Concentration (Cmax) of IBI321 From Day 1 up to 2 years
Secondary Minimum Serum Concentration (Cmin) of IBI321 From Day 1 up to 2 years
Secondary Clearance (CL) of IBI321 From Day 1 up to 2 years
Secondary Percentage of Participants with Anti-Drug Antibodies (ADAs) and Neutralizing Antibody (Nab) to IBI321 From Day 1 up to 2 years
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