Actively Recruiting
A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
Led by CStone Pharmaceuticals · Updated on 2025-08-11
480
Participants Needed
38
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug CS5001 used as a single agent and in combination with systemic therapies in patients with advanced hematological and solid tumors.
CONDITIONS
Official Title
A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For solid tumor patients in dose escalation, must have confirmed unresectable advanced solid tumor with disease progression after at least 1 prior systemic therapy.
- For lymphoma patients in dose escalation, must have confirmed Hodgkin or non-Hodgkin B-cell lymphoma with progression after at least 2 prior systemic therapies.
- For monotherapy cohorts, must have relapsed/refractory lymphomas or advanced solid tumors with failure of previous standard treatments; solid tumors must express ROR1.
- For combination therapy cohorts, DLBCL patients must be treatment-naïve or have failed at least one prior therapy; solid tumor patients must be naïve to PD-1/PD-L1 inhibitors and have failed first-line or standard therapy.
- At least one evaluable lesion per RECIST v1.1 (solid tumors) or 2014 Lugano Criteria (lymphoma) for dose escalation; at least one measurable lesion for dose expansion.
- Life expectancy greater than 3 months.
- ECOG performance status of 0 to 2.
- Adequate organ function.
You will not qualify if you...
- Disease suitable for local curative treatment or candidacy for stem cell transplant (lymphoma).
- History of second active malignancy within 3 years, except apparently cured locally curable cancers.
- Prior participation in studies targeting ROR1 before or during this study (dose expansion).
- Known CNS lymphoma or solid tumor brain metastases that are symptomatic, untreated, or require therapy.
- Other acute or chronic medical or psychiatric conditions.
- Immunodeficiency, active autoimmune disease, or conditions requiring systemic steroids.
- Peripheral edema, pericardial effusion, ascites needing intervention or limiting daily activity, or history of peripheral vascular diseases.
- Active infections needing systemic therapy within 2 weeks before first dose.
- Known HIV/AIDS infection.
- Significant cardiovascular disease within 6 months before first dose.
- Abnormal screening ECG.
- Major surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other anti-cancer treatment within 21 days before first dose.
- Live vaccine administration within 28 days before first dose.
- Active graft versus host disease.
- Active alcohol or drug abuse.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
North Shore Hematology Oncology Associates
East Setauket, New York, United States, 11733
Actively Recruiting
2
Columbia U. - Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
3
BUMC - Mary Crowley Cancer Research Centers (MCCRC)
Dallas, Texas, United States, 75201-7307
Actively Recruiting
4
Scientia Clinical Research Limited
Randwick, New South Wales, Australia, 2031
Actively Recruiting
5
Ashford Cancer Centre Research
Adelaide, South Australia, Australia
Terminated
6
Central Adelaide Local Health Network Incorporated
Adelaide, South Australia, Australia
Actively Recruiting
7
Royal Adelaide Hospital (RAH)
Adelaide, South Australia, Australia
Actively Recruiting
8
Epworth Freemasons Medical Centre
East Melbourne, Victoria, Australia
Actively Recruiting
9
Epworth Foundation trading as Epworth HealthCare
Melbourne, Victoria, Australia
Not Yet Recruiting
10
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Not Yet Recruiting
11
Anhui Provincial Hospital,
Hefei, Anhui, China
Not Yet Recruiting
12
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
13
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Terminated
14
Yanda Lu Dao Pei Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
15
The Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China
Actively Recruiting
16
Fujian Cancer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
17
Guangdong Province Hospital
Guangzhou, Guangdong, China
Actively Recruiting
18
Sun YatSen University Cancer Center
Guangzhou, Guangdong, China
Not Yet Recruiting
19
Guangxi Medical University Affiliated Tumour Hospital
Nanning, Guangxi, China
Actively Recruiting
20
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
21
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
22
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
23
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
24
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
25
Hunan Cancer Hospital
Changsha, Hunan, China
Not Yet Recruiting
26
Jiangsu province hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
27
The First Affiliated Hospital of Soochow University
Suzhu, Jiangsu, China
Actively Recruiting
28
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Not Yet Recruiting
29
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Actively Recruiting
30
The first Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Not Yet Recruiting
31
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
32
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
33
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
34
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Terminated
35
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
36
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
37
Yunnan Cancer Hospital
Kunming, Yunnan, China
Not Yet Recruiting
38
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
C
Crystal Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here