Solid Tumor
Conditions
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
Interventions
DRUGIBI325 + sintilimab
IBI325 + sintilimab combination does-escalation Patients will receive IBI325 and sintilimab until progressive disease, intolerability, or other reasons leading to treatment discontinuation
DRUGIBI325
IBI325 monotherapy does-escalation Patients will receive IBI325 until progressive disease, intolerability, or other reasons leading to treatment discontinuation
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with DLT | 28 days post first dose | Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose |
| Number of patients with treatment related AEs | Up to 90 days post last dose | Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration (Cmax) | Up to 90 days post last dose | — |
| Time at which maximum concentration (Tmax) | Up to 90 days post last dose | — |
| Number of patients with response | Every 6 weeks until progressive disease or up to 24 months after treatment | Number of patients with response per RECIST 1.1 |
| Positive rate of ADA and Nab | Up to 90 days post last dose | — |
| The half-life (t1/2) | Up to 90 days post last dose | — |
| The area under the curve (AUC) | Up to 90 days post last dose | — |
Countries
China
Outcome results
None listed