RecruitingPhase 1Phase 2NCT06741644

A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors

A Phase I/II, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS2009, a Tri-specific Antibody Targeting PD-1/VEGFA/CTLA-4, as Monotherapy and Combination Therapy in Participants With Advanced Solid Tumors


Sponsor

CStone Pharmaceuticals

Enrollment

660 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first-in-human (FIH), open-label, and multi-center Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS2009 as Monotherapy and Combination Therapy in Participants with Advanced Solid Tumors. The study is comprised of a Phase I dose escalation and Phase II dose expansion.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 5-FU, a drug called CS2009, and others for people with advanced solid tumors. The study is currently recruiting participants at 33 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCS2009

CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).

DRUGCS2009

CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 14/21-day cycles (Q2W/Q3W).

DRUGPemetrexed

IV infusion

DRUGCarboplatin

IV infusion

DRUGPaclitaxel

IV infusion

DRUGEtoposide

IV infusion

DRUGNab-paclitaxel

IV infusion

DRUGOxaliplatin

IV infusion

DRUGCapecitabine

oral tablets

DRUGDocetaxel

IV infusion

DRUGLeucovorin

IV infusion

DRUG5-FU

IV infusion

DRUGCisplatin

IV infusion


Locations(33)

START Los Angeles, LLC

Los Angeles, California, United States

NEXT Dallas

Irving, Texas, United States

Alfred Hospital (Alfred Health)

Melbourne, Australia

Austin Hospital (Austin Health)

Melbourne, Australia

Monash Medical Centre (Monash Health)

Melbourne, Australia

Peter Maccallum Cancer Centre Research

Melbourne, Australia

Icon Cancer Centre South Brisbane

South Brisbane, Australia

Blacktown Hospital

Sydney, Australia

Macquarie University Hospital

Sydney, Australia

Scientia Clinical Research Ltd

Sydney, Australia

Beijing Cancer Hospital

Beijing, China

Jilin Cancer Hospital

Changchun, China

Hunan Cancer Hospital

Changsha, China

Sichuan Cancer Hospital

Chengdu, China

West China Hospital of Sichuan University

Chengdu, China

Fujian Cancer Hospital

Fuzhou, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Sun Yat-Sen University Cancer Center

Guangzhou, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Anhui Provincial Hospital

Hefei, China

Central Hospital Affiliated to Shandong First Medical University

Jinan, China

Linyi Cancer Hospital

Linyi, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Nanjing Drum Tower Hospital

Nanjing, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shanghai East Hospital

Shanghai, China

Shanghai Pulmonary Hospital

Shanghai, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Xuzhou Central Hospital

Xuzhou, China

Henan Cancer Hospital

Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT06741644


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