Actively Recruiting
A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activities of CS5001, an Anti-ROR1 Antibody-Drug Conjugate, Alone and Combined With Systemic Therapies in Patients With Advanced Solid Tumors and Lymphomas
Led by CStone Pharmaceuticals · Updated on 2025-08-11
480
Participants Needed
38
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effects of an experimental drug called CS5001 in people with advanced solid tumors and lymphomas. This study is a first-in-human trial, meaning it is the first time CS5001 is being tested in humans. The study aims to find safe dosage levels and observe how well the drug works alone or combined with other cancer treatments. Participants may receive CS5001 either alone or together with other systemic therapies such as Rituximab, Gemcitabine, Oxaliplatin, Lenalidomide, Cyclophosphamide, Doxorubicin, Vincristine, or Prednisone. The doses and schedules are determined by a safety committee. The study includes a dose escalation phase to find appropriate dosing, followed by a dose expansion phase to further evaluate the drug's effects. During the study, participants will be closely monitored for side effects and treatment responses using criteria specific to solid tumors and lymphomas. Researchers will assess the maximum tolerated dose, recommended dose for future studies, adverse events, and objective response rate up to two years. Blood tests will measure drug concentrations and antibody levels. Safety is followed until 90 days after the last dose or until new cancer treatments begin. The total duration of participation varies by individual treatment and response.
CONDITIONS
Brief Title
A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- For solid tumor patients in dose escalation: pathologically confirmed unresectable advanced solid tumor with disease progression after at least 1 prior systemic therapy
- For lymphoma patients in dose escalation: pathologically confirmed Hodgkin or non-Hodgkin B-cell lymphoma with disease progression after at least 2 prior systemic therapies
- For monotherapy cohorts: relapsed/refractory lymphomas or advanced solid tumors with failure of previous standard treatments; solid tumor patients must have ROR1-positive tumors
- For combination therapy cohorts: DLBCL patients either treatment-nafve or 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 treatment
- At least one evaluable or measurable lesion per standard tumor response criteria
- Life expectancy greater than 3 months
- ECOG performance status 0-2
- Adequate organ function
You will not qualify if you...
- Disease suitable for local treatment with curative intent or candidacy for stem cell transplant in lymphoma
- History of second malignancy active within past 3 years except cured local cancers
- Participation in other ROR1-targeting studies before or during study (dose expansion phase)
- Known symptomatic or untreated CNS lymphoma or solid tumor brain metastases
- Other acute or chronic medical or psychiatric conditions
- Diagnosis of immunodeficiency, active autoimmune disease, or need for systemic steroids
- Peripheral edema, pericardial effusion, or ascites requiring intervention or limiting daily activity
- Active infections requiring systemic therapy within 2 weeks before first dose
- Known HIV-positive or AIDS
- Significant cardiovascular disease within 6 months before first dose
- Significant ECG abnormalities
- Major surgery, chemotherapy, radiotherapy, targeted or immunotherapy within 21 days before first dose
- Live vaccine 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months for dose escalation
Participants receive initial dosing of CS5001 alone or combined with other systemic therapies as determined by the Safety Monitoring Committee.
Multiple visits during dose escalation for safety and dose assessment
Duration - Up to 2 years for dose expansion
Participants receive CS5001 and possibly additional systemic therapies including Rituximab, Gemcitabine, Oxaliplatin, Lenalidomide, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone as per cohort assignment.
Regular visits for treatment administration and monitoring
Duration - Up to 90 days after last dose, with some assessments up to 30 days
Participants are monitored for adverse events, pharmacokinetics, anti-CS5001 antibodies, and treatment response after the last dose of investigational product or initiation of a new anti-cancer treatment.
Approximately 6 post-treatment visits
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
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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