Suspended

C019199 and Sintilimab for Advanced Solid Tumors

Study Aim

This study aims to evaluate the safety, determine the appropriate dose, and assess the effectiveness of C019199 combined with Sintilimab in adults with advanced solid tumors.

What is being tested

C019199

+ Sintilimab

Drug

Who is being recruted

From 18 to 75 Years

+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: July 2023

See protocol details

Summary

Principal SponsorFujian Haixi Pharmaceuticals Co., Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 19, 2023

Actual date on which the first participant was enrolled.

This clinical study is exploring a new treatment approach for individuals with advanced solid tumors, which are cancers that form in solid organs or tissues. The purpose is to assess both safety and effectiveness of a new drug, referred to as C019199, when used together with an existing drug called Sintilimab. This study is important because it aims to find a new combination treatment that could potentially improve outcomes for people with these challenging cancer types. The study is divided into two parts. In the first part, participants will receive varying doses of C019199 along with a fixed dose of 200 mg of Sintilimab, which is administered through an intravenous infusion every three weeks. This phase seeks to determine the safest and most effective dose for further testing. The next part will continue with the most suitable dose found in phase one, focusing on evaluating how well this combination works and its safety in treating selected solid tumors. The study will closely monitor participants for any side effects and the overall impact on tumor growth.

Official TitleA Phase I/II Clinical Study on the Safety, Tolerability and Preliminary Efficacy of C019199 in Combination With Sintilimab in Patients With Advanced Solid Tumors

NCT06220318

Principal SponsorFujian Haixi Pharmaceuticals Co., Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

155 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate

Histologically or cytologically confirmed locally advanced or metastatic solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists;

Phase II: have measurable disease based on RECIST 1.1 ;

Life expectancy of 3 months or more;

ECOG score: 0-1;

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12 exclusion criteria prevent from participating

Known active infection of human immunodeficiency virus (HIV) or hepatitis C virus (HCV);

Detection of active or untreated CNS metastases on baseline imaging assessments by CT or MRI during screening: a) If new asymptomatic CNS metastases are detected on baseline scans, subjects must receive radiotherapy and/or surgery for CNS metastases, and can be enrolled without repeat CNS imaging if meeting all other criteria; b) Subjects with history of treated brain or meningeal metastases can be enrolled if clinically stable for at least 2 months and systemic high-dose corticosteroids (\>10 mg/day prednisone or equivalent) has been discontinued for at least 4 weeks.

Severe psychological or psychiatric abnormalities that may affect compliance with study requirements;

Incomplete recovery from prior therapy toxicities (i.e. grade 2 or higher toxicities at screening, except for alopecia, pigmentation changes, or immune-mediated hypothyroidism that is stable with hormone replacement);

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Patients with selected tumors will received oral C019199 at a starting dose of 100mg once daily in combination with intravenous Sintilimab 200mg every 3 weeks ( Q3W ) on a 21-day treatment cycle until disease progression, development of unacceptable toxicity, or withdrawal of consent .

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

The First Affiliated Hospital of Xiamen University

Xiamen, ChinaOpen The First Affiliated Hospital of Xiamen University in Google Maps

Suspended

Hunan Cancer Hospital

Changsha, China

Suspended2 Study Centers