A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
A Phase I, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, Combined With Sintilimab in Patients With Advanced Solid Tumor
1 other identifier
interventional
60
1 country
1
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 advanced solid tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedStudy Start
First participant enrolled
March 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2023
CompletedFebruary 18, 2022
February 1, 2022
1 year
February 16, 2022
February 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patients with DLT
Number of patients who experienced a dose-limiting toxicity within the first 42 days after the first dose
42 days post first dose
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 Outcomes (1)
Number of patients with response
Every 6 weeks until progressive disease or up to 24 months after treatment, whichever came first
Study Arms (1)
IBI325 and Sintilimab combination does-escalation
EXPERIMENTALInterventions
IBI325 + sintilimab combination does-escalation Patients will receive IBI325 monotherapy on Cycle 1 Day 1 ,and then receive IBI325 and sintilimab combination until progressive disease, intolerability, or other reasons leading to treatment discontinuation
Eligibility Criteria
You may qualify if:
- 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
- \. 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.
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong Province Cancer Hospital
Jinan, Shandong, 250117, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the hospital
Study Record Dates
First Submitted
February 16, 2022
First Posted
February 18, 2022
Study Start
March 23, 2022
Primary Completion
March 23, 2023
Study Completion
November 23, 2023
Last Updated
February 18, 2022
Record last verified: 2022-02