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A Study of CS5001 for Advanced Solid Tumors and Lymphomas

This study is testing a new experimental drug called CS5001, both by itself and with other treatments like Rituximab, Gemcitabine, Oxaliplatin, and Lenalidomide. It's for people aged 18 and older with advanced solid tumors or lymphomas that have continued to grow despite previous treatments. The main goals are to find the safest dose of CS5001 and to see how often side effects happen and how severe they are. Researchers will also look at how well CS5001 works. This is a first-time-in-human study, meaning it's one of the first times CS5001 is being tested in people.

Study design
This is an interventional study planning to enroll 480 participants. It is a first-in-human study evaluating CS5001 alone and in combination with other therapies.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured until 90 days after the last dose of the study drug or until a new anti-cancer treatment begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05279300

A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas

Suspended
PHASE1Ages 18+InterventionalTreatment
CStone Pharmaceuticals
~480 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:CS5001RituximabGemcitabineOxaliplatinLenalidomideCyclophosphamide

At a glance

Recruiting sites
0 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)
Measured over About 6 months
+3 more outcomes measured

Conditions

Advanced Solid Tumor
Advanced Lymphoma

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NCT05279300

Where you'd take part

This study runs at 38 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, Chinano site contact published

  • Ashford Cancer Centre Research

    Adelaide, South Australia, Australiano site contact published

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, Chinano site contact published

  • BUMC - Mary Crowley Cancer Research Centers (MCCRC)

    Dallas, Texasno site contact published

  • Columbia U. - Herbert Irving Comprehensive Cancer Center

    New York, New Yorkno site contact published

  • Epworth Foundation trading as Epworth HealthCare

    Melbourne, Victoria, Australiano site contact published

  • Epworth Freemasons Medical Centre

    East Melbourne, Victoria, Australiano site contact published

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, Chinano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.

Exclusion

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.
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.

What this trial measures

  • Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)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)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 eventsUntil 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)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.