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A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

A Phase Ib/II, Multicenter Open-label Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

NCT04200404•CStone Pharmaceuticals

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia

Key Dates

Start Date

December 13, 2019

Primary Completion Date

May 13, 2021

Completion Date

August 18, 2021

Last Updated

May 6, 2022

Enrollment

ACTUAL participants

Conditions

Advanced Refractory Solid Tumors

Interventions

CS1001

DRUG

Regorafenib

DRUG

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TERMINATEDPHASE1

Safety and Tolerability Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

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COMPLETEDPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Exploratory Study of Novel MSLN CAR-T Cell Therapy in Patients With MSLN-positive Advanced Refractory Solid Tumors

Safety and Tolerability Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

An Extension Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors (PRaG2.0)

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Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors