A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase Ib, Open-Label, Multi-Center, Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05172856
• Other study ID #: CIBI321A103
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2021
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Yang Wu
• Phone: 18117822381
• Email: yang.wu[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 31, 2024
• Est. primary completion date: June 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. 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 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.

5. Pregnancy, lactation, breastfeeding.

6. Previous exposure to any anti-TIGIT antibody, or recombinant protein.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• IBI321
IBI321 at a dose no higher than RP2D, D1 IV Q3W.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

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	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	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)
Secondary	Overall Survival (OS)		From Day 1 to up to 2 years
Secondary	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
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) to IBI321		From Day 1 up to 2 years
Secondary	Percentage of Participants with Neutralizing Antibody (Nab) to IBI321		From Day 1 up to 2 years