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

A Phase I, Multicenter,Open-label,Dose-Escalation and Expansion Study of CS1001 in Combination With Donafenib in Patients With Advanced Solid Tumors

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Donafenib; Drug: CS1001

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ye Guo, MD; Phone Number: 13501678472; Email: pattrickguo@gmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Eastern Hospital
      • Contact: Yan Guo, MD; Phone Number: 13501678472; Email: pattrickguo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Collaborators: CStone Pharmaceuticals
• Investigators: Principal Investigator: Ye Guo, MD, Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2020
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 12, 2020
• First Posted (ACTUAL): July 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CS1001/Donafenib-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No