A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: IBI325 and sintilimab combination does-escalation
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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
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Experimental: IBI325 monotherapy does-escalation
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Drug: IBI325
IBI325 monotherapy does-escalation Patients will receive IBI325 until progressive disease, intolerability, or other reasons leading to treatment discontinuation
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- The area under the curve (AUC) [Up to 90 days post last dose]
- Maximum concentration (Cmax) [Up to 90 days post last dose]
- Time at which maximum concentration (Tmax) [Up to 90 days post last dose]
- The half-life (t1/2) [Up to 90 days post last dose]
- Positive rate of ADA and Nab [Up to 90 days post last dose]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed, locally advanced unresectable or metastatic tumors.
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At least one evaluable or measurable lesion per RECIST 1.1
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Male or female subject at least 18 years old and no more than 75 years old.
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Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
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Must have adequate organ function
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Be able to provide archived or fresh tumor tissues-
Exclusion Criteria:
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Previous exposure to any anti-CD73 monoclonal antibody
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Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
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Unstable central nervous system netastases
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Known active autoimmune disease or inflammatory disease
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Known active infectious disease
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Other uncontrolled systematic disease that may increase the risk of participating the study-
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Shandong Province Cancer Hospital | Jinan | Shandong | China | 250117 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI325A101