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New treatment option for Advanced Solid Tumors
Official title A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06741644
What this study is testing
What is CS2009?
CS2009 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Failure of established standard of care for advanced disease, or no available standard of care. Phase II:
You likely can't join if
- 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...
- Receipt of systemic corticosteroid treatment or any other form of immune suppressing treatment within 7 days prior to the first dose of...
- 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.
See the full eligibility 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...
- 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...
- Female participants of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational product.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Irving, Texas, United States
- Melbourne, Australia
- South Brisbane, Australia
- Sydney, Australia
- Beijing, China
- Changchun, China
- Changsha, China
- Chengdu, China
- Fuzhou, China
- Guangzhou, China
- Hangzhou, China
- Harbin, China
- Hefei, China
- Jinan, China
- Linyi, China
- Nanchang, China
- Nanjing, China
- Shanghai, China
- Wuhan, China
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Irving, Texas, United States; Melbourne, Australia; South Brisbane, Australia; Sydney, Australia; Beijing, China and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.