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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05119998
Other study ID # CIBI325A101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 8, 2022
Est. completion date August 8, 2023

Study information

Verified date October 2022
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date August 8, 2023
Est. primary completion date July 27, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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-

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Shandong Province Cancer Hospital Jinan Shandong

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 Number of patients with DLT Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose 28 days post first dose
Primary Number of patients with treatment related AEs Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose Up to 90 days post last dose
Secondary Number of patients with response Number of patients with response per RECIST 1.1 Every 6 weeks until progressive disease or up to 24 months after treatment
Secondary The area under the curve (AUC) Up to 90 days post last dose
Secondary Maximum concentration (Cmax) Up to 90 days post last dose
Secondary Time at which maximum concentration (Tmax) Up to 90 days post last dose
Secondary The half-life (t1/2) Up to 90 days post last dose
Secondary Positive rate of ADA and Nab Up to 90 days post last dose
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