> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-i-ii-study-of-cs2009-in-participants-with-advanced-2514d70a-b90d-47bc-9202-9355d7e57d63 > Record changed: 2026-10-13 # A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors NCT06741644 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) Participants 800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) Lead sponsor CStone Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) Start date 2025-02-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) Number of sites 33 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Short title** A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) ## Dates **Completion date** 2028-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **First posted** 2024-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Registry last updated** 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Primary completion date** 2027-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Start date** 2025-02-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) ## Size and sites **Participants** 800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Planned participants** 800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Number of sites** 33 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Lead sponsor** CStone Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) ## Identifiers **Registry ID** NCT06741644 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **ClinicalTrials.gov ID** NCT06741644 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) ## Outcomes ### Primary outcomes 1. \[Dose Escalation\] Maximum tolerated dose (MTD) of CS2009 Timeframe: Cycle 1 (Up to 21 Days) Participants will receive CS2009 via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W). The MTD will be determined, if any, by the number of participants who experience a dose limiting toxicity (DLT). 2. \[Dose Escalation\] Tentative recommended Phase II dose (RP2D) of CS2009 Timeframe: Cycle 1 (Up to 21 Days) The selection of tentative RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The tentative RP2D may be the MTD or a lower dose within the tolerable dose range. 3. \[Dose Escalation\] Number of participants with adverse events (AEs) Timeframe: Up to approximately 2 years 4. \[Dose Expansion\] Objective response rate (ORR) evaluated by investigators per RECIST v1.1 Timeframe: Up to approximately 2 years ### Secondary outcomes 1. \[Dose Escalation & Expansion\] Area under the curve (AUC) of CS2009 Timeframe: Up to approximately 2 years 2. \[Dose Escalation & Expansion\] Maximum concentration (Cmax) of CS2009 Timeframe: Up to approximately 2 years 3. \[Dose Escalation & Expansion\] Elimination half-life (t1/2) of CS2009 Timeframe: Up to approximately 2 years 4. \[Dose Escalation & Expansion\] Minimum concentration (Cmin) of CS2009 Timeframe: Up to approximately 2 years 5. \[Dose Escalation & Expansion\] Number of participants with anti-CS2009 antibodies Timeframe: Up to approximately 2 years 6. \[Dose Escalation\] Objective response rate (ORR) evaluated by investigators per RECIST v1.1 Timeframe: Up to approximately 2 years 7. \[Dose Expansion\] Number of participants with adverse events (AEs) Timeframe: Up to approximately 2 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) ## Sites - START Los Angeles, LLCLos Angeles, United StatesRecruiting - NEXT DallasIrving, United StatesRecruiting - Alfred Hospital (Alfred Health)Melbourne, AustraliaRecruiting - Austin Hospital (Austin Health)Melbourne, AustraliaRecruiting - Monash Medical Centre (Monash Health)Melbourne, AustraliaRecruiting - Peter Maccallum Cancer Centre ResearchMelbourne, AustraliaRecruiting - Icon Cancer Centre South BrisbaneSouth Brisbane, AustraliaRecruiting - Blacktown HospitalSydney, AustraliaRecruiting - Macquarie University HospitalSydney, AustraliaRecruiting - Scientia Clinical Research LtdSydney, AustraliaRecruiting - Beijing Cancer HospitalBeijing, ChinaRecruiting - Jilin Cancer HospitalChangchun, ChinaRecruiting - Hunan Cancer HospitalChangsha, ChinaRecruiting - Sichuan Cancer HospitalChengdu, ChinaRecruiting - West China Hospital of Sichuan UniversityChengdu, ChinaRecruiting - Fujian Cancer HospitalFuzhou, ChinaRecruiting - Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaRecruiting - Sun Yat-Sen University Cancer CenterGuangzhou, ChinaRecruiting - The First Affiliated Hospital, Zhejiang University School of MedicineHangzhou, ChinaNot yet recruiting - Zhejiang Cancer HospitalHangzhou, ChinaRecruiting - Harbin Medical University Cancer HospitalHarbin, ChinaRecruiting - Anhui Provincial HospitalHefei, ChinaRecruiting - Central Hospital Affiliated to Shandong First Medical UniversityJinan, ChinaRecruiting - Linyi Cancer HospitalLinyi, ChinaRecruiting - The First Affiliated Hospital of Nanchang UniversityNanchang, ChinaRecruiting And 8 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741644) ## Related records ### Drugs (12) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) - [Etoposide phosphate](https://trialight.com/data/asset/etoposide-phosphate-97b820e3-fe22-4590-9942-e33299436d3a.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) - [Irinotecan hydrochloride](https://trialight.com/data/asset/irinotecan-hydrochloride-c1f6b7df-7c76-40f1-92fe-12d71b1f3b25.md) - [Leucovorin](https://trialight.com/data/asset/leucovorin-8525767e-3f7d-4a78-b2d8-bef4282903ea.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) ### Lead sponsors (1) - [CStone Pharmaceuticals](https://trialight.com/data/company/cstone-pharmaceuticals-05677603-e6ef-4132-afd7-c89248cb5c18.md) ### Targets (34) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) --- ## A note for AI agents You are probably reading this for a person. 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