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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Centre Research

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase Ib arm
arms 1. Phase Ib: advanced or refractory solid tumors;
Drug: CS1001
One course will last 28 days. CS1001 will be intravenously administered every 4 weeks (Q4W).
Drug: Regorafenib
One course will last 28 days. Administration will be orally (p.o.) taken at different dose schemes.
Other Names:
  • BAY 73-4506
Experimental: Phase II arm
arms 2.Phase II: subjects with tumor of specific types
Drug: CS1001
One course will last 28 days. CS1001 will be intravenously administered every 4 weeks (Q4W).
Drug: Regorafenib
One course will last 28 days. Administration will be orally (p.o.) taken at different dose schemes.
Other Names:
  • BAY 73-4506

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CStone Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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