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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
One course will last 28 days. CS1001 will be intravenously administered every 4 weeks (Q4W).
One course will last 28 days. Administration will be orally (p.o.) taken at different dose schemes.
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Phase Ib (Safety Evaluation): Number of participants with adverse events
Time frame: 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
Phase II (Efficacy Expansion): Objective response rate (ORR)
Time frame: Up to 2 years
Phase Ib (Safety Evaluation): Objective response rate (ORR)
Time frame: Up to 2 years
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Disease control rate (DCR)
Time frame: Up to 2 years
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Progression Free Survival (PFS)
Time frame: Up to 2 years
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Duration of Response (DoR)
Time frame: Up to 2 years
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Overall Survival (OS)
Time frame: 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
Phase II (Efficacy Expansion): : Number of participants with adverse events
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Time frame: 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
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
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
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
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
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
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