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A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04472858
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : July 16, 2021
Sponsor:
Collaborator:
CStone Pharmaceuticals
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary:
This study will evaluate the safety, tolerability, pharmacokinetics and treatment effect of CS1001 in combination with Donafenib in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: Donafenib Drug: CS1001 Phase 1

Detailed Description:
This trail uses an open, multi-center study design, Contains two parts: a dose escalation part and a dose expansion part.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multicenter,Open-label,Dose-Escalation and Expansion Study of CS1001 in Combination With Donafenib in Patients With Advanced Solid Tumors
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Cholangiocarcinoma
Cholangiocarcinoma
Drug: 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.

Drug: CS1001
CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days

Experimental: Squamous cell carcinoma of the head and neck
Squamous cell carcinoma of the head and neck(HNSCC)
Drug: 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.

Drug: CS1001
CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days

Experimental: Endometrial cancer
Endometrial cancer
Drug: 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.

Drug: CS1001
CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: From the day of first dose to 21 days after last dose ]
  2. To determine the dose limiting toxicity (DLT) [ Time Frame: In the dose escalation part, from the day of first dose to 21 days after last dose ]
  3. To determine the maximum tolerated dose(MTD) [ Time Frame: In the dose escalation part, from the day of first dose to 21 days after last dose ]
  4. To determine the recommended dose of phase II [ Time Frame: In the dose escalation part, from the day of first dose to 21 days after last dose ]
  5. Objective response rate as determined by the Invertigator using RECIST V1.1 [ Time Frame: In the dose escalation part, from the day of first dose to 21 days after last dose ]

Secondary Outcome Measures :
  1. Anti-CS1001 antibody [ Time Frame: From the day of first dose to 21 days after last dose ]
  2. Objective response rate (ORR) [ Time Frame: From the day of first dose to 21 days after last dose ]
  3. Overall survival(OS) [ Time Frame: From the day of first dose to 21 days after last dose ]
  4. Progression free survival(PFS) [ Time Frame: From the day of first dose to 21 days after last dose ]
  5. Duration of remission (DOR) [ Time Frame: From the day of first dose to 21 days after last dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fully understand this study and voluntarily sign ICF;
  • 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:

  • Any history of active autoimmune diseases or autoimmune diseases; patients with vitiligo or asthma that has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04472858


Contacts
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Contact: Ye Guo, MD 13501678472 pattrickguo@gmail.com

Locations
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China, Shanghai
Shanghai Eastern Hospital Recruiting
Shanghai, Shanghai, China
Contact: Yan Guo, MD    13501678472    pattrickguo@gmail.com   
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
CStone Pharmaceuticals
Investigators
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Principal Investigator: Ye Guo, MD Shanghai East Hospital
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Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT04472858    
Other Study ID Numbers: CS1001/Donafenib-101
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms