Study of IBI318 in Participants With Advanced Malignancies
NCT ID: NCT03875157
Last Updated: 2023-02-27
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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COMPLETED
PHASE1
103 participants
INTERVENTIONAL
2019-04-19
2023-02-16
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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IBI318 DL1
IBI318
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318 DL2
IBI318
1 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318 DL3
IBI318
3 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318 DL4
IBI318
10 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318 DL5
IBI318
30 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318 DL6
IBI318
100 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318 DL7
IBI318
300 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318 DL8
IBI318
600 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318 DL7b
IBI318
Intravenous infusion, C1D1 and afterwards Q3W
IBI318 DL8b
IBI318
Intravenous infusion, C1D1 and afterwards Q3W
IBI318 RP2D
IBI318
Intravenous infusion Q3W
Interventions
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IBI318
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318
1 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318
3 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318
10 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318
30 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318
100 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318
300 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318
600 mg intravenous infusion, C1D1 and afterwards Q2W
IBI318
Intravenous infusion, C1D1 and afterwards Q3W
IBI318
Intravenous infusion, C1D1 and afterwards Q3W
IBI318
Intravenous infusion Q3W
Eligibility Criteria
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Inclusion Criteria
2. Men or women 18 years or older
3. Expected survival time ≥ 12 weeks
4. Tumor assessment according to RECIST v1.1, at least one measurable lesion
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Have adequate organ and bone marrow function
7. Male participants and female participants must agree to use contraception during the treatment period and within 180 days after the treatment period
8. Female subjects must not be pregnant or breastfeeding. If premenopausal, negative urine or serum pregnancy tests are required
9. Ia: Subjects with locally advanced, recurrent or metastatic histologically or cytologically confirmed solid tumors or hematologic tumors and are refractory or intolerant to existing standard treatments
10. Ib: Metastatic non-small cell lung cancer, advanced liver cancer, advanced esophageal squamous cell cancer, advanced gastric cancer, or other tumors that have been proved by histology or cytology with initial therapeutic effect in Phase Ia
Exclusion Criteria
2. Participation in another interventional clinical study, an observational (non-interventional) clinical study, or a follow-up phase of an interventional study
3. Receive last anti-tumor treatment within 4 weeks prior to the first dose of study drug
4. Use of immunosuppressive drugs within 4 weeks prior to the first dose of study drug
5. Require long-term steroid therapy or any other form of immunosuppressive therapy not including inhaled steroids
6. Toxicity (excluding hair loss or fatigue) caused by previous antitumor therapy that did not recover to NCI CTCAE v 5.0 level 0-1 within 4 weeks prior to the first dose of study drug
7. Received major surgery or has unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose of study drug
8. Expect to receive other anti-tumor treatments during study (allowing palliative radiotherapy)
9. History of infectious pneumonitis that required steroids or has current pneumonitis
10. Known active untreated CNS metastases and/or spinal cord compression and/or cancerous meningitis, or with a history of soft meningeal cancer
11. Active autoimmune disease that has required systemic treatment in past 2 years
12. Known active Hepatitis B or Hepatitis C virus
13. Uncontrolled concomitant diseases or neurological, psychiatric/social conditions that could affect study compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent
14. Known history of human immunodeficiency virus (HIV) infection
15. Known history of active tuberculosis (TB) or active syphilis
16. History of allogeneic organ transplantation or hematopoietic stem cell transplantation
17. Accompanied by uncontrolled third interstitial fluids requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc.
18. Known severe allergic reactions to other monoclonal antibodies or are allergic to any IBI318 formulation component
19. Female subjects who are pregnant or lactating
18 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun Yat-sen University Cancer Center
Guangzhou, , China
Countries
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Other Identifiers
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CIBI318A101
Identifier Type: -
Identifier Source: org_study_id
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