Actively Recruiting
A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors
Led by CStone Pharmaceuticals · Updated on 2026-04-15
660
Participants Needed
31
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Willing and able to follow scheduled visits, treatment plans, lab tests, and study procedures.
- Age 18 years or older at consent.
- Pathologically or cytologically confirmed unresectable advanced solid tumors (e.g., non-small cell lung cancer, small cell lung cancer, renal cell carcinoma, hepatocellular carcinoma, gastric cancer, ovarian cancer, cervical cancer).
- For Phase I: Disease progressed after standard treatments or no standard care available.
- For Phase II: At least one measurable tumor lesion as per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
- Fertile males and females of childbearing potential agree to effective birth control from consent through 180 days after last study drug dose.
- Females of childbearing potential must have a negative pregnancy test within 7 days before first dose.
You will not qualify if you...
- History of another active cancer within the past 3 years, except cured locally curable cancers.
- Known primary central nervous system tumors or symptomatic/untreated brain metastases.
- Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage within 4 weeks before first dose.
- Use of systemic corticosteroids or immune-suppressing treatments within 7 days before first dose.
- Active or past inflammatory bowel disease.
- History or presence of interstitial lung disease or pneumonitis requiring steroids.
- Active infections needing systemic treatment within 2 weeks before first dose.
- Positive for HIV/AIDS.
- Active Hepatitis B or C infection.
- Active pulmonary tuberculosis.
- Major surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other anti-cancer treatments within 21 days before first dose.
- Palliative radiotherapy within 14 days or radioactive drug within 56 days before first dose.
- Live vaccine administration within 28 days before first dose.
- History of allogeneic organ or stem cell transplantation.
- Use of antitumor Chinese herbal or patent medicines within 7 days before first dose.
- Participation in other investigational drug trials within 21 days before first dose.
- Known hypersensitivity to study drug components or monoclonal antibodies.
- Unresolved toxic effects from prior treatments worse than grade 1.
- Active alcohol or drug abuse.
- Pregnant or breastfeeding females.
- Other medical or psychiatric conditions increasing study risks.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Alfred Hospital (Alfred Health)
Melbourne, Australia
Actively Recruiting
2
Austin Hospital (Austin Health)
Melbourne, Australia
Actively Recruiting
3
Monash Medical Centre (Monash Health)
Melbourne, Australia
Actively Recruiting
4
Peter Maccallum Cancer Centre Research
Melbourne, Australia
Actively Recruiting
5
Icon Cancer Centre South Brisbane
South Brisbane, Australia
Actively Recruiting
6
Blacktown Hospital
Sydney, Australia
Actively Recruiting
7
Macquarie University Hospital
Sydney, Australia
Actively Recruiting
8
Scientia Clinical Research Ltd
Sydney, Australia
Actively Recruiting
9
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
10
Jilin Cancer Hospital
Changchun, China
Actively Recruiting
11
Hunan Cancer Hospital
Changsha, China
Not Yet Recruiting
12
Sichuan Cancer Hospital
Chengdu, China
Actively Recruiting
13
West China Hospital of Sichuan University
Chengdu, China
Actively Recruiting
14
Fujian Cancer Hospital
Fuzhou, China
Actively Recruiting
15
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Actively Recruiting
16
Sun Yat-Sen University Cancer Center
Guangzhou, China
Not Yet Recruiting
17
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
18
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
19
Harbin Medical University Cancer Hospital
Harbin, China
Actively Recruiting
20
Anhui Provincial Hospital
Hefei, China
Actively Recruiting
21
Central Hospital Affiliated to Shandong First Medical University
Jinan, China
Actively Recruiting
22
Linyi Cancer Hospital
Linyi, China
Actively Recruiting
23
The First Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
24
Nanjing Drum Tower Hospital
Nanjing, China
Actively Recruiting
25
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
26
Shanghai East Hospital
Shanghai, China
Actively Recruiting
27
Shanghai Pulmonary Hospital
Shanghai, China
Actively Recruiting
28
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
29
Xuzhou Central Hospital
Xuzhou, China
Actively Recruiting
30
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
31
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
J
Jingru Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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