Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2021-05-25
2022-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort A
IBI188
intravenous
Sintilimab
intravenous
Cohort B
IBI188
intravenous
Cisplatin/Carboplatin
intravenous
Bevacizumab
intravenous
Pemetrexed
intravenous
Cohort C
IBI188
intravenous
GM-CSF
subcutaneous injection
Cohort D
IBI188
intravenous
Sintilimab
intravenous
Interventions
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IBI188
intravenous
GM-CSF
subcutaneous injection
Cisplatin/Carboplatin
intravenous
Bevacizumab
intravenous
Sintilimab
intravenous
Pemetrexed
intravenous
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥ 18 years (≥ 12 years is acceptable in Cohort C).
3. Able to provide archived or fresh tumor tissue samples for biomarker assessment.
4. Have at least one measurable lesion according to RECIST version 1.1.
5. ECCG PS score of 0-2.
6. Adequate organ and bone marrow functions .
7. Life expectancy ≥ 12 weeks.
8. 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.
9. 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 Criteria
2. Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody (except Cohort C).
3. Concurrent participation in another clinical study.
4. The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.
5. 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.
6. 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.
7. Known hypersensitivity to IBI188 or any ingredient in the study drug product.
8. History of other primary malignancies.
9. Female subjects who are pregnant or lactating.
10. Other ineligible conditions considered by the investigator.
12 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ba Yi
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Zhang Dahong
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincial People's Hospital
Guo Hongqian
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Fang Meiyu
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Xie Yu
Role: PRINCIPAL_INVESTIGATOR
Hunan Cancer Hospital
Liu Jisheng
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Soochow University
Wang Ying
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincial People's Hospital
Wang Haiying
Role: PRINCIPAL_INVESTIGATOR
Shougang Hospital, Peking University
Wang Mengzhao
Role: PRINCIPAL_INVESTIGATOR
Shougang Hospital, Peking University
Lv Qiang
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial People's Hospital
Li Xiangping
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Liu Guihong
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Xuzhou Medical University
Mou Weiqi
Role: PRINCIPAL_INVESTIGATOR
Chongqing University Cancer Hospital
Guo Wei
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College
Wang Wei
Role: PRINCIPAL_INVESTIGATOR
Hunan Cancer Hospital
Xu Chongyuan
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Countries
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Other Identifiers
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CIBI188A104
Identifier Type: -
Identifier Source: org_study_id
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