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Can a smart drug deliver a One-Two punch to advanced cancers?

NCT ID NCT05279300

Disease control Sponsor: CStone Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This trial tests an experimental drug called CS5001, designed to seek out and destroy cancer cells that carry a specific marker (ROR1). It is being studied in people with advanced solid tumors or lymphomas that have progressed after standard treatments. The study will first find the safest dose, then test how well it works alone or combined with other cancer therapies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CS5001, an antibody-drug conjugate that targets a protein called ROR1 on cancer cells, given alone or with standard cancer drugs
What this could lead to
If successful, this could lead to a new treatment option for advanced solid tumors and lymphomas that have not responded to prior therapies.
What could go wrong
This is an early-phase trial, so the drug may not be effective or may cause significant side effects. The results are preliminary and need confirmation in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

B-cell non-Hodgkin lymphoma diffuse large B-cell lymphoma Hodgkins lymphoma lymphoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced lymphoma Advanced solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, China

  • Ashford Cancer Centre Research

    Adelaide, South Australia, Australia

  • BUMC - Mary Crowley Cancer Research Centers (MCCRC)

    Dallas, Texas, 75201-7307, United States

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, China

  • Columbia U. - Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032, United States

  • Epworth Foundation trading as Epworth HealthCare

    Melbourne, Victoria, Australia

  • Epworth Freemasons Medical Centre

    East Melbourne, Victoria, Australia

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • Fudan University Shanghai Cancer Hospital

    Shanghai, Shanghai Municipality, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, China

  • Guangdong Province Hospital

    Guangzhou, Guangdong, China

  • Guangxi Medical University Affiliated Tumour Hospital

    Nanning, Guangxi, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, China

  • Hunan Cancer Hospital

    Changsha, Hunan, China

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality, China

  • Jiangsu province hospital

    Nanjing, Jiangsu, China

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, China

  • North Shore Hematology Oncology Associates

    East Setauket, New York, 11733, United States

  • Royal Adelaide Hospital

    Adelaide, South Australia, Australia

  • Royal Adelaide Hospital (RAH)

    Adelaide, South Australia, Australia

  • Royal Hobart Hospital

    Hobart, Tasmania, Australia

  • Scientia Clinical Research Limited

    Randwick, New South Wales, 2031, Australia

  • Shandong Cancer Hospital

    Jinan, Shandong, China

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, China

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, China

  • Sun YatSen University Cancer Center

    Guangzhou, Guangdong, China

  • The Cancer Hospital Affiliated to Chongqing University

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Soochow University

    Suzhu, Jiangsu, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, China

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, China

  • The first Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, China

  • Westmead Hospital

    Westmead, New South Wales, Australia

  • Yanda Lu Dao Pei Hospital

    Beijing, Beijing Municipality, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, China

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