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A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors

NCT04472858 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-29

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability, pharmacokinetics and treatment effect of CS1001 in combination with Donafenib in patients with advanced solid tumors.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

Donafenib

dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study.

DRUG

CS1001

CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days

Sponsors & Collaborators

Principal Investigators

  • Ye Guo, MD · Shanghai East Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Entities

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 NCT04472858 on ClinicalTrials.gov