A Phase I Study of IBI325 in Patients With Advanced Solid Tumor

NCT ID: NCT05119998

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-08
• Study Completion Date: 2023-08-08

Brief Summary

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced solid tumors

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBI325 and sintilimab combination does-escalation

Group Type: EXPERIMENTAL

IBI325 + sintilimab

Intervention Type: DRUG

IBI325 + sintilimab combination does-escalation Patients will receive IBI325 and sintilimab until progressive disease, intolerability, or other reasons leading to treatment discontinuation

IBI325 monotherapy does-escalation

Group Type: EXPERIMENTAL

IBI325

Intervention Type: DRUG

IBI325 monotherapy does-escalation Patients will receive IBI325 until progressive disease, intolerability, or other reasons leading to treatment discontinuation

Interventions

IBI325 + sintilimab

IBI325 + sintilimab combination does-escalation Patients will receive IBI325 and sintilimab until progressive disease, intolerability, or other reasons leading to treatment discontinuation

Intervention Type: DRUG

IBI325

IBI325 monotherapy does-escalation Patients will receive IBI325 until progressive disease, intolerability, or other reasons leading to treatment discontinuation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed, locally advanced unresectable or metastatic tumors.

2. At least one evaluable or measurable lesion per RECIST 1.1

3. Male or female subject at least 18 years old and no more than 75 years old.

4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.

5. Must have adequate organ function

6. Be able to provide archived or fresh tumor tissues-

Exclusion Criteria

1. Previous exposure to any anti-CD73 monoclonal antibody

2. Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.

3. Unstable central nervous system netastases

4. Known active autoimmune disease or inflammatory disease

5. Known active infectious disease

6. Other uncontrolled systematic disease that may increase the risk of participating the study-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shandong Province Cancer Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

CIBI325A101

Identifier Type: -

Identifier Source: org_study_id