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A Study of CS1001 in Subjects 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. Identifier: NCT04200404
Recruitment Status : Recruiting
First Posted : December 16, 2019
Last Update Posted : January 22, 2020
Information provided by (Responsible Party):
CStone Pharmaceuticals

Brief Summary:
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of CS1001 in combination with regorafenib in patients with advanced or refractory cancers

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Intervention Model: Single Group 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: CS1001+Regorafenib
In the dose escalation part, the dose levels will be escalated following a BOIN design. In the dose expansion part, patients will be assigned to different groups based on their tumor types and treated at the RP2D.
Drug: CS1001
CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days

Drug: Regorafenib
The starting dose of regorafenib is 80 mg orally, once daily for the first 21 days of each 28-day cycle.
Other Name: BAY 73-4506

Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: From the day of first dose to 90 days after last dose ]
  2. Dose Limiting Toxicity (DLT) [ Time Frame: First cycle (28 days) ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: To be performed every 8 weeks during treatment period (up to 2 years) ]
  2. Area under the plasma concentration-time curve (AUC) [ Time Frame: From the day of first dose to 30 days after last dose ]
  3. Maximum plasma concentration (Cmax) [ Time Frame: From the day of first dose to 30 days after last dose ]
  4. Time to reach maximum plasma concentration (Tmax) [ Time Frame: From the day of first dose to 30 days after last dose ]
  5. Terminal elimination half-life (t1/2) [ Time Frame: From the day of first dose to 30 days after last dose ]
  6. Anti-CS1001 antibody [ Time Frame: From the day of first dose to 30 days after last dose ]

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.

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

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.
  • 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.

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 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.
  • 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.

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 identifier (NCT number): NCT04200404

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Contact: Wendie Yuan +86 21 61097678

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Australia, South Australia
Ashford Cancer Centre Research Recruiting
Kurralta Park, South Australia, Australia, 5037
Sponsors and Collaborators
CStone Pharmaceuticals

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Responsible Party: CStone Pharmaceuticals Identifier: NCT04200404    
Other Study ID Numbers: CS1001/Regorafenib-101
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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