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Phase I/II Study of CS2009 for Advanced Solid Tumors

This study is testing a new drug called CS2009 for people with advanced solid tumors. Researchers want to find the safest and most effective dose of CS2009, both on its own and when given with other chemotherapy drugs like Pemetrexed, Carboplatin, or Paclitaxel. The main goals are to understand the drug's safety, how your body handles it (pharmacokinetics), and if it shows any signs of shrinking tumors. You could be eligible if you are 18 years or older, have advanced solid tumors that cannot be removed by surgery, and are willing to follow the study plan. The study is currently enrolling up to 660 participants.

Study design
This is a Phase I/II study, meaning it's an early-stage trial. It is open-label, so both you and your doctors will know which treatment you are receiving. Up to 660 participants are planned.
What's involved
You would receive CS2009 through an IV (intravenous) infusion on Day 1 of repeated 14-day or 21-day cycles. You will need to attend scheduled visits, undergo laboratory tests, and follow other study procedures.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for side effects for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06741644

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
CStone Pharmaceuticals
~800 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:CS2009PemetrexedCarboplatinPaclitaxelEtoposideNab-paclitaxel

At a glance

Recruiting sites
32 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
[Dose Escalation] Maximum tolerated dose (MTD) of CS2009
Measured over Cycle 1 (Up to 21 Days)
+3 more outcomes measured

Conditions

Advanced Solid Tumors

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NCT06741644

Where you'd take part

This study runs at 33 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alfred Hospital (Alfred Health)

    Melbourne, Australiano site contact published

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Chinano site contact published

    Recruiting

  • Austin Hospital (Austin Health)

    Melbourne, Australiano site contact published

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Chinano site contact published

    Recruiting

  • Blacktown Hospital

    Sydney, Australiano site contact published

    Recruiting

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, Chinano site contact published

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Chinano site contact published

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Chinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Jingru Wang
[email protected]
+86 18017113282
Email the study team

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Eligibility criteria

Inclusion

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.
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.
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

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.

What this trial measures

  • [Dose Escalation] Maximum tolerated dose (MTD) of CS2009Cycle 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).

  • [Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS2009Cycle 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.

  • [Dose Escalation] Number of participants with adverse events (AEs)Up to approximately 2 years
  • [Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1Up to approximately 2 years