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

NCT04200404 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-05-06

No results posted yet for this study

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)

Conditions

  • Advanced Refractory Solid Tumors

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-13
Primary Completion
2021-05-13
Completion
2021-08-18

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200404 on ClinicalTrials.gov