NCT04472858

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

3.1 years

First QC Date

July 8, 2020

Last Update Submit

November 28, 2022

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • 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

Study Arms (3)

Cholangiocarcinoma

EXPERIMENTAL

Cholangiocarcinoma

Drug: DonafenibDrug: CS1001

Squamous cell carcinoma of the head and neck

EXPERIMENTAL

Squamous cell carcinoma of the head and neck（HNSCC）

Drug: DonafenibDrug: CS1001

Endometrial cancer

EXPERIMENTAL

Endometrial cancer

Drug: DonafenibDrug: CS1001

Interventions

DonafenibDRUG

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.

CholangiocarcinomaEndometrial cancerSquamous cell carcinoma of the head and neck
CS1001DRUG

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

CholangiocarcinomaEndometrial cancerSquamous cell carcinoma of the head and neck

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fully understand this study and voluntarily sign ICF;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Eastern Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

donafenib

Study Officials

  • Ye Guo, MD

    Shanghai East Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Guo, MD

CONTACT

13501678472pattrickguo@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 16, 2020

Study Start

October 15, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 29, 2022

Record last verified: 2022-11

Locations

CN(1)