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Clinical Trials in the USA / NCT06741644
Recruiting Phase 1/2

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

NCT06741644 · tracked via the Priya Life Science USA tracker
Sponsor
CStone Pharmaceuticals
Phase
Phase 1/2
Started
2025-02-24
Last updated
2026-08-20

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

CS2009CS2009PemetrexedCarboplatinPaclitaxelEtoposideNab-paclitaxelOxaliplatinCapecitabineDocetaxelLeucovorin5-FUCisplatinGemcitabineIrinotecan

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

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

Pemetrexed: IV infusion

Carboplatin: IV infusion

Paclitaxel: IV infusion

Etoposide: IV infusion

Nab-paclitaxel: IV infusion

Oxaliplatin: IV infusion

Capecitabine: oral tablets

Docetaxel: IV infusion

Leucovorin: IV infusion

5-FU: IV infusion

Cisplatin: IV infusion

Gemcitabine: IV infusion

Irinotecan: IV infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document. * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Age ≥ 18 years on the day of signing informed consent. Phase I: * Pathologically or cytologically confirmed, unresectable advanced solid tumors, including but not limited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), gastric cancer (GC), ovarian cancer (OC), cervical cancer (CC), etc. * Failure of established standard of care for advanced disease, or no available standard of care. Phase II: * Pathologically or cytologically confirmed unresectable advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), etc. * Participants with at least one measurable lesion as defined per RECIST v1.1 solid tumor. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function. * Fertile male participants and female participants of childbearing potential must be willing to use an effective method of birth control from providing signed consent and for 180 days after the last investigational product administration. * Female participants of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational product. Exclusion Criteria: * History of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured. * Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy. * Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage within 4 weeks prior to the first dose of investigational product. * Receipt of systemic corticosteroid treatment or any other form of immune suppressing treatment within 7 days prior to the first dose of investigational product. * Active or prior history of definite inflammatory bowel disease. * History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or presence of active or suspected ILD/pneumonitis. * Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product. * Positive for human immunodeficiency virus (HIV) or presence of acquired immune deficiency syndrome (AIDS). * Active Hepatitis B or C infection. * Active pulmonary tuberculosis (TB). * Major surgery, chemotherapy, definitive radiotherapy, target therapy, immunotherapy, or other anti-cancer therapy within 21 days prior to the first dose of investigational product. * Palliative radiotherapy within 14 days prior to the first dose of investigational product, or receipt of radioactive drug within 56 days prior to the first dose of investigational product. * Administration of live vaccine within 28 days prior to the first dose of investigational product. * History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. * Receipt of antitumor Chinese herbal preparations or Chinese patent medicine within 7 days prior to the first dose of investigational product. * Receipt of any other investigational drugs within 21 days prior to the first dose in this trial. * History of hypersensitivity or idiosyncrasy to the excipients of the study drug or any monoclonal antibody. * Any toxic effects of prior therapy or surgical procedures unresolved to baseline severity or NCI-CTCAE Version 5.0 Grade ≤ 1. * Active alcohol or drug abuse. * Female participants who are pregnant or breastfeeding. * Other acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product administration.

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
START Los Angeles, LLC Los Angeles California Recruiting
NEXT Dallas Irving Texas Recruiting
Alfred Hospital (Alfred Health) Melbourne Australia Recruiting
Austin Hospital (Austin Health) Melbourne Australia Recruiting
Monash Medical Centre (Monash Health) Melbourne Australia Recruiting
Peter Maccallum Cancer Centre Research Melbourne Australia Recruiting
Icon Cancer Centre South Brisbane South Brisbane Australia Recruiting
Blacktown Hospital Sydney Australia Recruiting
Macquarie University Hospital Sydney Australia Recruiting
Scientia Clinical Research Ltd Sydney Australia Recruiting
Beijing Cancer Hospital Beijing China Recruiting
Jilin Cancer Hospital Changchun China Recruiting
Hunan Cancer Hospital Changsha China Recruiting
Sichuan Cancer Hospital Chengdu China Recruiting
West China Hospital of Sichuan University Chengdu China Recruiting
Fujian Cancer Hospital Fuzhou China Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou China Recruiting
Sun Yat-Sen University Cancer Center Guangzhou China Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou China Not Yet Recruiting
Zhejiang Cancer Hospital Hangzhou China Recruiting
Harbin Medical University Cancer Hospital Harbin China Recruiting
Anhui Provincial Hospital Hefei China Recruiting
Central Hospital Affiliated to Shandong First Medical University Jinan China Recruiting
Linyi Cancer Hospital Linyi China Recruiting
The First Affiliated Hospital of Nanchang University Nanchang China Recruiting
Nanjing Drum Tower Hospital Nanjing China Recruiting
Fudan University Shanghai Cancer Center Shanghai China Recruiting
Shanghai East Hospital Shanghai China Recruiting
Shanghai Pulmonary Hospital Shanghai China Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan China Recruiting
Xuzhou Central Hospital Xuzhou China Recruiting
Henan Cancer Hospital Zhengzhou China Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou China Recruiting

More CStone Pharmaceuticals trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06741644 on ClinicalTrials.gov ↗ ← All trials in the USA