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A Study of CS1003 in Subjects With Advanced Solid Tumors

NCT03475251 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-02-18

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors.

Conditions

Interventions

BIOLOGICAL

CS1003

In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type.

BIOLOGICAL

CS1003

CS1003 to be intravenously administered at the dose level determined during the dose escalation part

DRUG

Regorafenib

Regorafenib to be orally administered at the protocol-specified dose level, once daily for the first 21 days of each 28-day cycle

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
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 NCT03475251 on ClinicalTrials.gov