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

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04472858
• Other study ID #: CS1001/Donafenib-101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 15, 2020
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Ye Guo, MD
• Phone: 13501678472
• Email: pattrickguo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Eastern Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd	CStone Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		From the day of first dose to 21 days after last dose
Primary	To determine the dose limiting toxicity (DLT)		In the dose escalation part, from the day of first dose to 21 days after last dose
Primary	To determine the maximum tolerated dose(MTD)		In the dose escalation part, from the day of first dose to 21 days after last dose
Primary	To determine the recommended dose of phase II		In the dose escalation part, from the day of first dose to 21 days after last dose
Primary	Objective response rate as determined by the Invertigator using RECIST V1.1		In the dose escalation part, from the day of first dose to 21 days after last dose
Secondary	Anti-CS1001 antibody		From the day of first dose to 21 days after last dose
Secondary	Objective response rate (ORR)		From the day of first dose to 21 days after last dose
Secondary	Overall survival(OS)		From the day of first dose to 21 days after last dose
Secondary	Progression free survival(PFS)		From the day of first dose to 21 days after last dose
Secondary	Duration of remission (DOR)		From the day of first dose to 21 days after last dose