Status:
UNKNOWN
A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
Lead Sponsor:
Shandong Cancer Hospital and Institute
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 combined with Sintilimab in patients with ad...
Eligibility Criteria
Inclusion
- Inclusion
- Histologically confirmed, locally advanced unresectable or metastatic tumors.
- At least one measurable lesion per RECIST 1.1
- Male or female subject at least 18 years old and no more than 75 years old.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
- Must have adequate organ function
- Be able to provide archived or fresh tumor tissues Exclusion
- 1\. Any anti-tumor treatment with 4 weeks, except 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
Exclusion
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 23 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05246995
Start Date
March 23 2022
End Date
November 23 2023
Last Update
February 18 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shandong Province Cancer Hospital
Jinan, Shandong, China, 250117