Advanced Solid TumorPhase 1NCT05279300
A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
A Phase 1 study testing CS5001, Rituximab and Gemcitabine in people with Advanced Solid Tumor and Advanced Lymphoma, run by CStone Pharmaceuticals at 38 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Advanced Lymphoma
- What is being tested?
- CS5001, Rituximab and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 28 Mar 2022to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For solid tumor patients of dose escalation, they must have pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy.
- For Lymphoma patients of dose escalation, they must have pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 World Health Organization(WHO) classification, with disease progression on or after at least 2 lines of prior systemic therapy.
- For mono-therapy cohorts, eligible patients must have pathologically confirmed relapsed/refractory (R/R) lymphomas or advanced solid tumors, and have demonstrated failure with previous line(s) of standard-of-care treatment. Patients in the solid tumor cohort must exhibit ROR1-positive expression in their baseline tumor tissues. For combination therapy cohorts, DLBCL patients must either be treatment-naïve or have experienced failure with at least one prior line of standard-of-care therapy to qualify for treatment with CS5001 in combination with first-line or subsequent standard-of-care therapies for DLBCL. Solid tumor patients must have pathologically confirmed disease, be naïve to PD-1/PD-L1 inhibitors, and have at least failed first-line therapy or standard-of-care treatment.
- For dose escalation, with at least one evaluable lesion as defined per Response Evaluation Criteria in Solid Tumours(RECIST) v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively. For dose expansion, with at least one measurable lesion as defined per RECIST v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively.
- Life expectancy > 3 months.
- Eastern Cooperative Oncology Group(ECOG) performance status 0-2.
- Have adequate organ function.
Who cannot join
- Has disease that is suitable for local treatment administered with curative intent. For lymphoma, candidacy for hematopoietic stem cell transplantation based on the Investigator's judgment.
- Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- For dose expansion: Participation in other studies involving therapies targeting ROR1 prior to study entry and/or during study participation.
- Has known central nervous system (CNS) lymphoma or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy.
- Has other acute or chronic medical or psychiatric conditions.
- Has a diagnosis of immunodeficiency, or has an active autoimmune disease or other conditions that require systemic steroid therapy.
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- Has peripheral edema, pericardial effusion, or ascites indicated for medical intervention or limiting activity of daily life. Or with a known history of peripheral vasculopathies.
- Patients with any active infections requiring systemic therapy within 2 weeks prior to the administration of the first dose of the study drug.
- Patients known to be human immunodeficiency virus (HIV)-positive or have acquired immune deficiency syndrome (AIDS).
- Significant cardiovascular disease within 6 months prior to the first dose of the study drug.
- Significant screening electrocardiogram (ECG) abnormalities.
- Has received major surgery, chemotherapy, definitive radiotherapy, target therapy, immunotherapy, or other anti-cancer therapy within 21 days prior to the administration of the first dose of the study drug.
- Administration of a live vaccine within 28 days prior to the administration of the first dose of the study drug.
- Has active graft versus host disease.
- With known active alcohol or drug abuse.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
38 sites in 3 countries.
38 sites in 3 countries
China27 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality
Yanda Lu Dao Pei Hospital
Beijing, Beijing Municipality
Hunan Cancer Hospital
Changsha, Hunan
The Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality
The Second Hospital of Dalian Medical University
Dalian, Liaoning
Fujian Cancer Hospital
Fuzhou, Fujian
Guangdong Province Hospital
Guangzhou, Guangdong
Sun YatSen University Cancer Center
Guangzhou, Guangdong
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Anhui Provincial Cancer Hospital
Hefei, Anhui
Shandong Cancer Hospital
Jinan, Shandong
Yunnan Cancer Hospital
Kunming, Yunnan
Jiangxi Cancer Hospital
Nanchang, Jiangxi
Jiangsu province hospital
Nanjing, Jiangsu
Guangxi Medical University Affiliated Tumour Hospital
Nanning, Guangxi
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality
Shanghai East Hospital
Shanghai, Shanghai Municipality
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
The First Affiliated Hospital of Soochow University
Suzhu, Jiangsu
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
Hubei Cancer Hospital
Wuhan, Hubei
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
The first Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Henan Cancer Hospital
Zhengzhou, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Australia8 sites
Ashford Cancer Centre Research
Adelaide, South Australia
Royal Adelaide Hospital (RAH)
Adelaide, South Australia
Royal Adelaide Hospital
Adelaide, South Australia
Epworth Freemasons Medical Centre
East Melbourne, Victoria
Royal Hobart Hospital
Hobart, Tasmania
Epworth Foundation trading as Epworth HealthCare
Melbourne, Victoria
Scientia Clinical Research Limited
Randwick, New South Wales, 2031
Westmead Hospital
Westmead, New South Wales
United States3 sites
BUMC - Mary Crowley Cancer Research Centers (MCCRC)
Dallas, Texas, 75201-7307
North Shore Hematology Oncology Associates
East Setauket, New York, 11733
Columbia U. - Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
About this study
Official title: 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, Used as A Single Agent and in Combination With Systemic Therapies in Patients With Advanced Solid Tumors and Lymphomas
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
- Advanced Solid Tumor, Advanced Lymphoma
- Being tested
- CS5001, Rituximab, Gemcitabine, Oxaliplatin, Lenalidomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS5001Drug
The dose and dosing schedule is decided by the Safety Monitoring Committee.
RituximabBiological
IV infusion
GemcitabineDrug
IV infusion
OxaliplatinDrug
IV infusion
LenalidomideDrug
PO
CyclophosphamideDrug
IV infusion
DoxorubicinDrug
IV infusion
VincristineDrug
IV infusion
PrednisoneDrug
PO
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Not described Receives: Drug: CS5001 |
| Dose expansion | Experimental | Not described Receives: Drug: CS5001; Biological: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)
Participants will receive CS5001 for injection once every three weeks. The MTD will be determined by the number of participants who experience a dose limiting toxicity (DLT).
Measured: About 6 months
Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part)
The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RP2D may be the MTD or may be a lower dose within the tolerable dose range.
Measured: About 6 months
Incident and severity of adverse events
Measured: Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
Objective Response Rate (ORR) (for dose expansion)
The percentage of participants with a CR or PR based on 2014 Lugano Classification Criteria for lymphomas, iwCLL 2018 guidelines for CLL/SLL and RECIST v1.1 for solid tumors.
Measured: Up to 2 years
Secondary outcomes (2)
Concentration of CS5001 total antibody
Measured: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Concentration of anti-CS5001 antibodies
Measured: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start28 Mar 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: The sponsor is temporarily pausing the trial to evaluate existing clinical data for long-term benefit-risk and optimize doses and dosing schedule.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279300
- Sponsor's protocol ID
- CS5001-101
- Status last verified
- Aug 2026
- First submitted
- 4 Mar 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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, Used as A Single Agent and in Combination With Systemic Therapies in Patients With Advanced Solid Tumors and Lymphomas
- ClinicalTrials.gov ID
- NCT05279300
- Acronym / sponsor ID
- CS5001-101
- Conditions
- Advanced Solid Tumor, Advanced Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The sponsor is temporarily pausing the trial to evaluate existing clinical data for long-term benefit-risk and optimize doses and dosing schedule.
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: CS5001 |
| Dose expansion | Experimental | Drug: CS5001, Biological: Rituximab, Drug: Gemcitabine, Drug: Oxaliplatin, Drug: Lenalidomide, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For solid tumor patients of dose escalation, they must have pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy.
- For Lymphoma patients of dose escalation, they must have pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 World Health Organization(WHO) classification, with disease progression on or after at least 2 lines of prior systemic therapy.
- For mono-therapy cohorts, eligible patients must have pathologically confirmed relapsed/refractory (R/R) lymphomas or advanced solid tumors, and have demonstrated failure with previous line(s) of standard-of-care treatment. Patients in the solid tumor cohort must exhibit ROR1-positive expression in their baseline tumor tissues. For combination therapy cohorts, DLBCL patients must either be treatment-naïve or have experienced failure with at least one prior line of standard-of-care therapy to qualify for treatment with CS5001 in combination with first-line or subsequent standard-of-care therapies for DLBCL. Solid tumor patients must have pathologically confirmed disease, be naïve to PD-1/PD-L1 inhibitors, and have at least failed first-line therapy or standard-of-care treatment.
- For dose escalation, with at least one evaluable lesion as defined per Response Evaluation Criteria in Solid Tumours(RECIST) v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively. For dose expansion, with at least one measurable lesion as defined per RECIST v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively.
- Life expectancy > 3 months.
Key exclusion criteria (16 listed)
- Has disease that is suitable for local treatment administered with curative intent. For lymphoma, candidacy for hematopoietic stem cell transplantation based on the Investigator's judgment.
- Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- For dose expansion: Participation in other studies involving therapies targeting ROR1 prior to study entry and/or during study participation.
- Has known central nervous system (CNS) lymphoma or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy.
- Has other acute or chronic medical or psychiatric conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS5001The dose and dosing schedule is decided by the Safety Monitoring Committee. | Drug | Dose escalation, Dose expansion |
| RituximabIV infusion | Biological | Dose expansion |
| GemcitabineIV infusion | Drug | Dose expansion |
| OxaliplatinIV infusion | Drug | Dose expansion |
| LenalidomidePO | Drug | Dose expansion |
| CyclophosphamideIV infusion | Drug | Dose expansion |
| DoxorubicinIV infusion | Drug | Dose expansion |
| VincristineIV infusion | Drug | Dose expansion |
| PrednisonePO | Drug | Dose expansion |
Primary outcome
Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)
Time frame: About 6 months
Participants will receive CS5001 for injection once every three weeks. The MTD will be determined by the number of participants who experience a dose limiting toxicity (DLT).
Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part)
Time frame: About 6 months
The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RP2D may be the MTD or may be a lower dose within the tolerable dose range.
Incident and severity of adverse events
Time frame: Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
Objective Response Rate (ORR) (for dose expansion)
Time frame: Up to 2 years
The percentage of participants with a CR or PR based on 2014 Lugano Classification Criteria for lymphomas, iwCLL 2018 guidelines for CLL/SLL and RECIST v1.1 for solid tumors.
2 secondary outcomes
Concentration of CS5001 total antibody
Time frame: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Concentration of anti-CS5001 antibodies
Time frame: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS5001, Rituximab and Gemcitabine in people with Advanced Solid Tumor and Advanced Lymphoma, run by CStone Pharmaceuticals at 38 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in China, Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part) (time frame: About 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.