IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT06349408
Last Updated: 2025-01-27
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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RECRUITING
PHASE1
250 participants
INTERVENTIONAL
2025-01-10
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-label: IBI3001 monotherapy
IBI3001
The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study.
IBI3001 is proposed to be administered by intravenous infusion (IV)
Interventions
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IBI3001
The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study.
IBI3001 is proposed to be administered by intravenous infusion (IV)
Eligibility Criteria
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Inclusion Criteria
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
3. Has an anticipated life expectancy of ≥ 12 weeks;
4. Adequate bone marrow and organ function:
5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.
6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.
Exclusion Criteria
2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;
3. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
4. Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
5. Known symptomatic central nervous system (CNS) metastases.
6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
7. History of endotracheal or gastrointestinal stent implantation;
8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
9. Esophageal or gastric varices requiring immediate intervention;
10. Not eligible to participate in this study at the discretion of the investigator;
11. Do not have adequate treatment washout period before study drug administration. -
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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Wollongong Public
Wollongong, New South Wales, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIBI3001A101
Identifier Type: -
Identifier Source: org_study_id
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