A Phase I, Multicenter,Open-label,Dose-Escalation and Expansion Study of CS1001 in Combination With Donafenib in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- CS1001
- Conditions
- Advanced Solid Tumor
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Detailed Description
This trail uses an open, multi-center study design, Contains two parts: a dose escalation part and a dose expansion part.
Investigators
Eligibility 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.
Arms & Interventions
Endometrial cancer
Endometrial cancer
Intervention: CS1001
Cholangiocarcinoma
Cholangiocarcinoma
Intervention: Donafenib
Cholangiocarcinoma
Cholangiocarcinoma
Intervention: CS1001
Squamous cell carcinoma of the head and neck
Squamous cell carcinoma of the head and neck（HNSCC）
Intervention: Donafenib
Squamous cell carcinoma of the head and neck
Squamous cell carcinoma of the head and neck（HNSCC）
Intervention: CS1001
Endometrial cancer
Endometrial cancer
Intervention: Donafenib
Outcomes
Primary Outcomes
Number of participants with adverse events
Time Frame: From the day of first dose to 21 days after last dose
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
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
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
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 Outcomes
- Anti-CS1001 antibody(From the day of first dose to 21 days after last dose)
- Objective response rate (ORR)(From the day of first dose to 21 days after last dose)
- Overall survival(OS)(From the day of first dose to 21 days after last dose)
- Progression free survival(PFS)(From the day of first dose to 21 days after last dose)
- Duration of remission (DOR)(From the day of first dose to 21 days after last dose)