Clinical trial NCT04472858: A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: CStone Pharmaceuticals
First posted: 2020-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: From the day of first dose to 21 days after last dose
measure: To determine the dose limiting toxicity (DLT)
timeFrame: In the dose escalation part, from the day of first dose to 21 days after last dose
measure: To determine the maximum tolerated dose(MTD)
timeFrame: In the dose escalation part, from the day of first dose to 21 days after last dose
measure: To determine the recommended dose of phase II
timeFrame: In the dose escalation part, from the day of first dose to 21 days after last dose
measure: Objective response rate as determined by the Invertigator using RECIST V1.1
timeFrame: In the dose escalation part, from the day of first dose to 21 days after last dose
Secondary outcomes:
measure: Anti-CS1001 antibody
timeFrame: From the day of first dose to 21 days after last dose
measure: Objective response rate (ORR)
timeFrame: From the day of first dose to 21 days after last dose
measure: Overall survival(OS)
timeFrame: From the day of first dose to 21 days after last dose
measure: Progression free survival(PFS)
timeFrame: From the day of first dose to 21 days after last dose
measure: Duration of remission (DOR)
timeFrame: From the day of first dose to 21 days after last dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eastern Hospital
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References: