Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, in Patients With Advanced Malignancies
NCT ID: NCT05164458
Last Updated: 2023-12-28
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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RECRUITING
PHASE1
320 participants
INTERVENTIONAL
2022-03-22
2024-09-30
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
SEQUENTIAL
TREATMENT
NONE
Study Groups
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IBI389
A dose escalation stage of IBI 389 monotherapy.
IBI 389 Injection
IBI 389 IV Q2\~Q3W Day 1
IBI 389 + sintilimab
A dose escalation stage of IBI 389 in combination with sintilimab.
IBI 308 injection
IBI308 IV 200mg Q3W Day1
IBI 389 Injection
IBI 389 IV Q2\~Q3W Day 1
Interventions
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IBI 308 injection
IBI308 IV 200mg Q3W Day1
IBI 389 Injection
IBI 389 IV Q2\~Q3W Day 1
Eligibility Criteria
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Inclusion Criteria
2. Male or female aged at 18-75 (inclusive) years;
3. Expected survival ≥12 weeks;
4. ECOG PS score 0 or 1;
5. Provide archival or fresh tissues for CLDN18.2 expression analysis;
6. Adequate laboratory parameters;
7. Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:
Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.
Ib: pancreatic carcinoma, gastric adenocarcinoma, advanced or metastatic solid tumors
Exclusion Criteria
2. Any investigational drugs received within 4 weeks prior to the first study treatment.
3. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
4. Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.
5. Medication requiring long-term systemic hormones or any other immunosuppression therapy.
6. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy.
7. There was unrecovered toxicity (excluding hair loss or fatigue) according to NCI CTCAE v5.0 induced by previous antitumor therapy (24 weeks before the first dose of study), and there were unrecovered immune-related adverse events (irAE) associated with immunotherapy.
8. Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.
9. History of autoimmune disease , present active autoimmune disease or inflammatory diseases
10. Present or history of pulmonary diseases such as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, pulmonary fibrosis, active pulmonary infection, severely impaired pulmonary function.
11. Positive human immunodeficiency virus (HIV) test.
12. Active hepatitis B or C, or tuberculosis.
13. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
14. History of gastrointestinal perforation and/or fistula at 6 months prior to study inclusion.
15. Hydrothorax, ascites, and pericardial effusion with clinical symptoms requiring drainage.
16. Known history of hypersensitivity to any components of the IBI389 or Sintilimab.
17. Uncontrolled complications of disease.
18. Other acute or chronic illness, mental illness, or abnormal laboratory test values that may increase the risk of study participation or administration of study drugs, or interfere with the interpretation of study results.
19. Pregnant or nursing females.
18 Years
75 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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West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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bi feng
Role: primary
Other Identifiers
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CIBI389A101
Identifier Type: -
Identifier Source: org_study_id