A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors
NCT ID: NCT04472858
Last Updated: 2022-11-29
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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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2020-10-15
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cholangiocarcinoma
Cholangiocarcinoma
Donafenib
dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study.
CS1001
CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days
Squamous cell carcinoma of the head and neck
Squamous cell carcinoma of the head and neck（HNSCC）
Donafenib
dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study.
CS1001
CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days
Endometrial cancer
Endometrial cancer
Donafenib
dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study.
CS1001
CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days
Interventions
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Donafenib
dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study.
CS1001
CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days
Eligibility Criteria
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Inclusion Criteria
* 18 to 75 years old (including 18 and 75 years old), male or female;
* Subjects with advanced solid tumors, including:
Phase I study:
subjects with advanced solid tumors confirmed by histology or cytology that are not suitable for surgical resection, or have failed or tolerated standard treatment, or have no standard treatment. Including but not limited to Cholangiocarcinoma , head and neck squamous cell carcinoma (HNSCC) and endometrial cancer.
Exclusion Criteria
* Participants with any condition that impairs their ability to take oral medication, such as lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
* Patients with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage and need to retain a catheter;
* Human immunodeficiency virus (HIV) antibody positive;
* Patients who are simultaneously infected with hepatitis B virus and hepatitis C virus;
* Lactating women. If they are willing to stop breastfeeding, they can also be included in this study.
18 Years
75 Years
ALL
No
Sponsors
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CStone Pharmaceuticals
INDUSTRY
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Ye Guo, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital
Locations
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Shanghai Eastern Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CS1001/Donafenib-101
Identifier Type: -
Identifier Source: org_study_id
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