- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04200404
A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors
May 5, 2022 updated by: CStone Pharmaceuticals
A Phase Ib/II, Multicenter Open-label Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors
This is a multicenter, open-label study of CS1001 in combination with regorafenib in participants with advanced or refractory cancers.
There will be a dose escalation portion in "allcomers"to find a suitable dose of regorafenib for combination use with CS1001.
This study will also enroll participants with specific tumor types in the phase II part of the study to assess the efficacy, pharmacokinetics and safety of the combined regimen (RP2D of regorafenib + CS 1001)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Australia
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Kurralta Park, South Australia, Australia, 5037
- Ashford Cancer Centre Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All participants must have unresectable advanced or metastatic tumors that have histologic or cytologic documentation confirmed.
- Participant must have at least one measurable lesion by CT or MRI per RECIST 1.1; radiographic tumor assessment should be performed within 28 days prior to initiation of study treatment.
- ECOG performance status score of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Fresh or archival tumor tissue must be provided for PD-L1 expression testing in selected cohorts.
- Adequate organ function
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result. Either Female or male participants must agree to use adequate contraceptive measures from signing informed consent and for 180 days after last investigational product administration, except for a participant with documented surgical sterilization or a postmenopausal female.
- Any toxic effects of prior anti-cancer therapy or surgical procedures resolved to baseline severity or NCI-CTCAE version 5 Grade 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
- Subjects with hepatitis B virus (HBV) infection must have HBV DNA < 2000 IU/mL at screening, and requires continue anti-HBV treatment in the study
Exclusion Criteria:
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- 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.
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis that is either symptomatic or untreated.
- Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control.
- Significant history of cardiac disease within 6 months prior to Day 1 of Cycle 1, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication, or left ventricular ejection fraction (LVEF) is below 50%.
- History or evidence of poorly controlled arterial hypertension.
- Any serious or uncontrolled medical disorder or active infection may increase the risk associated with study participation or dose.
- Administration of drugs known as strong CYP3A4 inducers or strong CYP3A4 inhibitors and the last dose was given in < 5 half-lives from the first investigational product administration.
- Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 28 days prior to the start of study treatment.
Other inclusion/exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase Ib arm
arms 1. Phase Ib: advanced or refractory solid tumors;
|
One course will last 28 days.
CS1001 will be intravenously administered every 4 weeks (Q4W).
One course will last 28 days.
Administration will be orally (p.o.) taken at different dose schemes.
Other Names:
|
Experimental: Phase II arm
arms 2.Phase II: subjects with tumor of specific types
|
One course will last 28 days.
CS1001 will be intravenously administered every 4 weeks (Q4W).
One course will last 28 days.
Administration will be orally (p.o.) taken at different dose schemes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phase Ib (Safety Evaluation): Number of participants with adverse events
Time Frame: Baseline up to 90 days post last dose, up to 2 years
|
Baseline up to 90 days post last dose, up to 2 years
|
Phase Ib (Safety Evaluation): Dose Limiting Toxicity (DLT)
Time Frame: Baseline up to 90 days post last dose, up to 2 years
|
Baseline up to 90 days post last dose, up to 2 years
|
Phase II (Efficacy Expansion): Objective response rate (ORR)
Time Frame: Up to 2 years
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phase Ib (Safety Evaluation): Objective response rate (ORR)
Time Frame: Up to 2 years
|
Up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Disease control rate (DCR)
Time Frame: Up to 2 years
|
Up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Progression Free Survival (PFS)
Time Frame: Up to 2 years
|
Up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Duration of Response (DoR)
Time Frame: Up to 2 years
|
Up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Overall Survival (OS)
Time Frame: Up to 2 years
|
Up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Occurrence of anti-CS1001 antibody
Time Frame: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
|
Phase II (Efficacy Expansion): : Number of participants with adverse events
Time Frame: Baseline up to 90 days post last dose, up to 2 years
|
Baseline up to 90 days post last dose, up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Area under the plasma concentration-time curve (AUC)0-t of CS1001
Time Frame: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Maximum plasma concentration (Cmax) of CS1001
Time Frame: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Time to reach maximum plasma concentration (Tmax) of CS1001
Time Frame: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Terminal elimination half-life (t1/2) of CS1001
Time Frame: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Clearance at Steady State (CLss) of CS1001
Time Frame: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
|
Phase Ib (Safety Evaluation): Maximum plasma concentration (Cmax) of regorafenib
Time Frame: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
|
Phase Ib (Safety Evaluation): Minimum plasma concentration (Cmin) of regorafenib
Time Frame: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2019
Primary Completion (Actual)
May 13, 2021
Study Completion (Actual)
August 18, 2021
Study Registration Dates
First Submitted
December 13, 2019
First Submitted That Met QC Criteria
December 13, 2019
First Posted (Actual)
December 16, 2019
Study Record Updates
Last Update Posted (Actual)
May 6, 2022
Last Update Submitted That Met QC Criteria
May 5, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS1001/Regorafenib-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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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