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Triple-Action antibody takes on advanced cancers

NCT ID NCT06741644

Disease control Sponsor: CStone Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 6 times

Summary

This study tests a new drug called CS2009, a tri-specific antibody that targets three proteins (PD-1, VEGFA, and CTLA-4) to fight advanced solid tumors. The trial has two phases: first, finding the safest dose, then expanding to see how well it shrinks tumors. About 660 adults with cancers like lung, kidney, or liver cancer that cannot be surgically removed are being recruited.

Why investors are watching

CStone Pharmaceuticals is running a first-in-human trial of CS2009, a tri-specific antibody that targets three proteins involved in tumor growth and immune evasion, in patients with advanced solid tumors. For a small company, this early-stage readout matters because it is the first test of whether the drug is safe and shows any sign of shrinking tumors, which could validate its pipeline and future value.

If it works: If the trial shows acceptable safety and early signs of tumor control, CStone could advance CS2009 to later-stage studies and potentially attract partnership interest. A positive result would give the company a credible experimental drug in a competitive field.

If it fails: Early-phase cancer trials often fail because the drug proves too toxic or shows little benefit, and this one has a large planned enrollment of 800 participants, which adds complexity and cost. A poor safety or efficacy signal could set the program back and hurt the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alfred Hospital (Alfred Health)

    RECRUITING

    Melbourne, Australia

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, China

  • Austin Hospital (Austin Health)

    RECRUITING

    Melbourne, Australia

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, China

  • Blacktown Hospital

    RECRUITING

    Sydney, Australia

  • Central Hospital Affiliated to Shandong First Medical University

    RECRUITING

    Jinan, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, China

  • Icon Cancer Centre South Brisbane

    RECRUITING

    South Brisbane, Australia

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, China

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, China

  • Macquarie University Hospital

    RECRUITING

    Sydney, Australia

  • Monash Medical Centre (Monash Health)

    RECRUITING

    Melbourne, Australia

  • NEXT Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, China

  • Peter Maccallum Cancer Centre Research

    RECRUITING

    Melbourne, Australia

  • START Los Angeles, LLC

    RECRUITING

    Los Angeles, California, 90025, United States

  • Scientia Clinical Research Ltd

    RECRUITING

    Sydney, Australia

  • Shanghai East Hospital

    RECRUITING

    Shanghai, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, China

  • Sichuan Cancer Hospital

    RECRUITING

    Chengdu, China

  • Sun Yat-Sen University Cancer Center

    RECRUITING

    Guangzhou, China

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

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    NOT_YET_RECRUITING

    Hangzhou, China

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

    RECRUITING

    Wuhan, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, China

  • Xuzhou Central Hospital

    RECRUITING

    Xuzhou, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, China

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