A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors
NCT ID: NCT06741644
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
660 participants
INTERVENTIONAL
2025-02-24
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Participants will be administered escalating doses of CS2009.
CS2009
CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
Dose Expansion
Participants will be administered the recommended dose(s) of CS2009 with or without chemotherapy according to dose-escalation data.
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
Irinotecan
IV infusion
Cisplatin
IV infusion
Interventions
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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
Irinotecan
IV infusion
Cisplatin
IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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CStone Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Central Contacts
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Other Identifiers
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CS2009-101
Identifier Type: -
Identifier Source: org_study_id
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