A Study of Dose Escalation of IBI321 in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase Ia/Ib, Open-Label, Multi-Center, Study of the Safety, Tolerability and Primary Efficacy of IBI321 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911894
• Other study ID #: CIBI321A102
• Status: Completed
• Phase: Phase 1
• Start date: June 21, 2021
• Est. completion date: February 17, 2023

Study information

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

Clinical Trial Summary

This first-in-human open-label, multicenter, dose-escalation and expansion 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: 16
• Est. completion date: February 17, 2023
• Est. primary completion date: January 30, 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

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

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	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

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