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Evaluating CS5001 for patients with advanced solid tumors and lymphomas

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

Phase 1 Interventional CStone Pharmaceuticals · NCT05279300

This study is testing a new drug called CS5001 to see if it can help people with advanced solid tumors and lymphomas who haven't had success with other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment480 (estimated)
Ages18 Years and up
SexAll
SponsorCStone Pharmaceuticals Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations38 sites (East Setauket, New York and 37 other locations)
Trial IDNCT05279300 on ClinicalTrials.gov

What this trial studies

This first-in-human study aims to assess the safety and preliminary efficacy of the experimental drug CS5001 in patients suffering from advanced solid tumors and lymphomas. The trial will involve dose escalation for patients with unresectable advanced solid tumors who have progressed after at least one prior systemic therapy, as well as those with specific types of lymphoma who have undergone multiple lines of treatment. Participants will be closely monitored for any adverse effects and potential therapeutic benefits of CS5001.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors or specific types of lymphoma who have not responded to previous treatments.

Not a fit: Patients with early-stage tumors or those who have not yet undergone systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors and lymphomas who have limited alternatives.

How similar studies have performed: While this approach is novel for CS5001, similar studies evaluating new treatments for advanced cancers have shown promise in the past.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

East Setauket, New York and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorAdvanced Lymphoma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.