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Advanced Solid TumorsPhase 1/2NCT06741644

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

A Phase 1/2 study testing CS2009, Pemetrexed and Carboplatin in people with Advanced Solid Tumors, run by CStone Pharmaceuticals at 33 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
CS2009, Pemetrexed and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
33 sitesin 3 countries
Study dates
24 Feb 2025to Jan 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

33 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Jingru Wang contact

+86 18017113282

wangjingru@cstonepharma.com

33 sites in 3 countries

China23 sites, 23 recruiting

  • Beijing Cancer Hospital

    Beijing

    Recruiting

  • Jilin Cancer Hospital

    Changchun

    Recruiting

  • Hunan Cancer Hospital

    Changsha

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Recruiting

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

    Guangzhou

    Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin

    Recruiting

  • Anhui Provincial Hospital

    Hefei

    Recruiting

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan

    Recruiting

  • Linyi Cancer Hospital

    Linyi

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Recruiting

  • Shanghai East Hospital

    Shanghai

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai

    Recruiting

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

    Wuhan

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Recruiting

Other trials in China

Australia8 sites, 8 recruiting

  • Alfred Hospital (Alfred Health)

    Melbourne

    Recruiting

  • Austin Hospital (Austin Health)

    Melbourne

    Recruiting

  • Monash Medical Centre (Monash Health)

    Melbourne

    Recruiting

  • Peter Maccallum Cancer Centre Research

    Melbourne

    Recruiting

  • Icon Cancer Centre South Brisbane

    South Brisbane

    Recruiting

  • Blacktown Hospital

    Sydney

    Recruiting

  • Macquarie University Hospital

    Sydney

    Recruiting

  • Scientia Clinical Research Ltd

    Sydney

    Recruiting

Other trials in Australia

United States2 sites, 2 recruiting

  • NEXT Dallas

    Irving, Texas, 75039

    Recruiting

  • START Los Angeles, LLC

    Los Angeles, California, 90025

    Recruiting

Other trials in United States

About this study

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

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.

Keywords
PD-1, VEGFA, CTLA4, tri-specific antibody, advanced solid tumors, Phase I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06741644
Study groupRoleWhat they receive
Dose EscalationExperimentalParticipants will be administered escalating doses of CS2009.
Receives: Drug: CS2009
Dose ExpansionExperimentalParticipants will be administered the recommended dose(s) of CS2009 with or without chemotherapy according to dose-escalation data.
Receives: Drug: CS2009; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel; Drug: Etoposide; Drug: Nab-paclitaxel; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Docetaxel; Drug: Leucovorin; Drug: 5-FU; Drug: Cisplatin; Drug: Gemcitabine; Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [Dose Escalation] Maximum tolerated dose (MTD) of CS2009

    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).

    Measured: Cycle 1 (Up to 21 Days)

  2. [Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS2009

    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.

    Measured: Cycle 1 (Up to 21 Days)

  3. [Dose Escalation] Number of participants with adverse events (AEs)

    Measured: Up to approximately 2 years

  4. [Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1

    Measured: Up to approximately 2 years

Secondary outcomes (7)

  1. [Dose Escalation & Expansion] Area under the curve (AUC) of CS2009

    Measured: Up to approximately 2 years

  2. [Dose Escalation & Expansion] Maximum concentration (Cmax) of CS2009

    Measured: Up to approximately 2 years

  3. [Dose Escalation & Expansion] Elimination half-life (t1/2) of CS2009

    Measured: Up to approximately 2 years

  4. [Dose Escalation & Expansion] Minimum concentration (Cmin) of CS2009

    Measured: Up to approximately 2 years

  5. [Dose Escalation & Expansion] Number of participants with anti-CS2009 antibodies

    Measured: Up to approximately 2 years

  6. [Dose Escalation] Objective response rate (ORR) evaluated by investigators per RECIST v1.1

    Measured: Up to approximately 2 years

  7. [Dose Expansion] Number of participants with adverse events (AEs)

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2024
  2. Study start24 Feb 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06741644
Sponsor's protocol ID
CS2009-101
Status last verified
Aug 2026
First submitted
15 Dec 2024
Last updated
20 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CS2009, Pemetrexed and Carboplatin in people with Advanced Solid Tumors, run by CStone Pharmaceuticals at 33 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in China, Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jingru Wang (+86 18017113282, wangjingru@cstonepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[Dose Escalation] Maximum tolerated dose (MTD) of CS2009 (time frame: Cycle 1 (Up to 21 Days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06741644.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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