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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: Donafenib; Drug: CS1001

• Registration Number: NCT04472858
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-12
• Study First Posted: 2020-07-16
• Study Start: 2020-10-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholangiocarcinoma	Donafenib	Cholangiocarcinoma
Cholangiocarcinoma	CS1001	Cholangiocarcinoma
Squamous cell carcinoma of the head and neck	Donafenib	Squamous cell carcinoma of the head and neck（HNSCC）
Squamous cell carcinoma of the head and neck	CS1001	Squamous cell carcinoma of the head and neck（HNSCC）
Endometrial cancer	Donafenib	Endometrial cancer
Endometrial cancer	CS1001	Endometrial cancer

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	From the day of first dose to 21 days after last dose
To determine the dose limiting toxicity (DLT)	In the dose escalation part, from the day of first dose to 21 days after last dose
To determine the maximum tolerated dose(MTD)	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	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	In the dose escalation part, from the day of first dose to 21 days after last dose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Eastern Hospital; 🇨🇳 Shanghai, Shanghai, China