Status:
TERMINATED
IBI188 Combination Therapy in Solid Tumors
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Solid Tumors
Lung Adenocarcinoma
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
A Phase Ib study aim to evaluate the efficacy, safety, and tolerability of IBI188 combination therapy in subjects with advanced malignancies
Eligibility Criteria
Inclusion
- Patients with locally advanced or metastatic solid tumors cannot be cured by surgery or other local treatments .
- Aged ≥ 18 years (≥ 12 years is acceptable in Cohort C).
- Able to provide archived or fresh tumor tissue samples for biomarker assessment.
- Have at least one measurable lesion according to RECIST version 1.1.
- ECCG PS score of 0-2.
- Adequate organ and bone marrow functions .
- Life expectancy ≥ 12 weeks.
- Female subjects of childbearing potential or male subjects with partners of childbearing potential should take effective contraceptive measures throughout the whole treatment period and until 6 months after treatment.
- Must voluntarily sign the Informed Consent Form (ICF), and be able to follow all study requirements and procedures. For the subjects enrolled in Cohort C who are ≥ 12 and \< 18 years old, in addition to obtaining the child's own consent, their guardians should provide informed consent and sign the ICF.
Exclusion
- Previous exposure to any CD47 antibody, SIRPα antibody, CD47/SIRPα recombinant protein or other inhibitors that act in the same pathway.
- Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody (except Cohort C).
- Concurrent participation in another clinical study.
- The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.
- Have undergone major surgical procedures within 4 weeks prior to the first dose of study treatment or planned to receive major surgery during the study treatment.
- Presence of toxicities (excluding alopecia and fatigue) induced by previous anti-tumor therapy that has not recovered to Grade 0 or 1 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 prior to the first dose of study treatment.
- Known hypersensitivity to IBI188 or any ingredient in the study drug product.
- History of other primary malignancies.
- Female subjects who are pregnant or lactating.
- Other ineligible conditions considered by the investigator.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04861948
Start Date
May 25 2021
End Date
July 30 2022
Last Update
October 4 2022
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China