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

Sponsor

CStone Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT04200404

Collaborator

Bayer (Industry)

Enrollment

Location

Arms

20.2

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

19 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 :

Dec 13, 2019

Actual Primary Completion Date :

May 13, 2021

Actual Study Completion Date :

Aug 18, 2021

Arms and Interventions

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 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

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 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Phase Ib (Safety Evaluation): Objective response rate (ORR) [Up to 2 years]
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Disease control rate (DCR) [Up to 2 years]
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Progression Free Survival (PFS) [Up to 2 years]
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Duration of Response (DoR) [Up to 2 years]
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Overall Survival (OS) [Up to 2 years]
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Occurrence of anti-CS1001 antibody [From first dose to 30 days after last dose, up to 2 years]
Phase II (Efficacy Expansion): : Number of participants with adverse events [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 [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 [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 [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 [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 [From first dose to 30 days after last dose, up to 2 years]
Phase Ib (Safety Evaluation): Maximum plasma concentration (Cmax) of regorafenib [From first dose to 30 days after last dose, up to 2 years]
Phase Ib (Safety Evaluation): Minimum plasma concentration (Cmin) of regorafenib [From first dose to 30 days after last dose, up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Other inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ashford Cancer Centre Research	Kurralta Park	South Australia	Australia	5037

Sponsors and Collaborators

CStone Pharmaceuticals
Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CStone Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04200404

Other Study ID Numbers:

CS1001/Regorafenib-101

First Posted:

Dec 16, 2019

Last Update Posted:

May 6, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of May 6, 2022