Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04200404
Recruitment Status : Recruiting
First Posted : December 16, 2019
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
CStone Pharmaceuticals

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Advanced Refractory Solid Tumors Drug: CS1001 Drug: Regorafenib Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II, Multicenter Open-label Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arm Intervention/treatment
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 Name: 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 Name: BAY 73-4506




Primary Outcome Measures :
  1. Phase Ib (Safety Evaluation): Number of participants with adverse events [ Time Frame: Baseline up to 90 days post last dose, up to 2 years ]
  2. Phase Ib (Safety Evaluation): Dose Limiting Toxicity (DLT) [ Time Frame: Baseline up to 90 days post last dose, up to 2 years ]
  3. Phase II (Efficacy Expansion): Objective response rate (ORR) [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Phase Ib (Safety Evaluation): Objective response rate (ORR) [ Time Frame: Up to 2 years ]
  2. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Disease control rate (DCR) [ Time Frame: Up to 2 years ]
  3. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]
  4. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Duration of Response (DoR) [ Time Frame: Up to 2 years ]
  5. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Overall Survival (OS) [ Time Frame: Up to 2 years ]
  6. 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 ]
  7. Phase II (Efficacy Expansion): : Number of participants with adverse events [ Time Frame: Baseline up to 90 days post last dose, up to 2 years ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200404


Contacts
Layout table for location contacts
Contact: Wendie Yuan +86 21 61097678 cstonera@cstonepharma.com

Locations
Layout table for location information
Australia, South Australia
Ashford Cancer Centre Research Recruiting
Kurralta Park, South Australia, Australia, 5037
Sponsors and Collaborators
CStone Pharmaceuticals
Bayer
Layout table for additonal information
Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04200404    
Other Study ID Numbers: CS1001/Regorafenib-101
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms