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

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04472858

Collaborator

CStone Pharmaceuticals (Industry)

Enrollment

Location

Arms

25.5

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: Donafenib Drug: CS1001	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cholangiocarcinoma 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 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

Arm

Intervention/Treatment

Experimental: Cholangiocarcinoma

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

Drug: CS1001

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

Experimental: Endometrial cancer

Endometrial cancer

Drug: Donafenib

Drug: CS1001

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Eastern Hospital	Shanghai	Shanghai	China

Sponsors and Collaborators

Suzhou Zelgen Biopharmaceuticals Co.,Ltd
CStone Pharmaceuticals

Investigators

Principal Investigator: Ye Guo, MD, Shanghai East Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

ClinicalTrials.gov Identifier:

NCT04472858

Other Study ID Numbers:

CS1001/Donafenib-101

First Posted:

Jul 16, 2020

Last Update Posted:

Jul 16, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jul 16, 2021