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New treatment option for Advanced Solid Tumor
Official title A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
ClinicalTrials.gov ID: NCT05279300
What this study is testing
What is CS5001?
CS5001 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For solid tumor patients of dose escalation, they must have pathologically confirmed, unresectable advanced solid tumor with disease progression on...
- For Lymphoma patients of dose escalation, they must have pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 World...
- For mono-therapy cohorts, eligible patients must have pathologically confirmed relapsed/refractory (R/R) lymphomas or advanced solid tumors, and have...
- 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...
- Life expectancy \> 3 months.
You likely can't join if
- Has disease that is suitable for local treatment administered with curative intent. For lymphoma, candidacy for hematopoietic stem cell...
- 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.
See the full eligibility 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...
- 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...
- 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...
- Life expectancy \> 3 months.
- Eastern Cooperative Oncology Group(ECOG) performance status 0-2.
- Have adequate organ function.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- East Setauket, New York, United States
- New York, New York, United States
- Dallas, Texas, United States
- Randwick, New South Wales, Australia
- Adelaide, South Australia, Australia
- East Melbourne, Victoria, Australia
- Melbourne, Victoria, Australia
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Shijiazhuang, Hebei, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Suzhu, Jiangsu, China
- Nanchang, Jiangxi, China
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include East Setauket, New York, United States; New York, New York, United States; Dallas, Texas, United States; Randwick, New South Wales, Australia; Adelaide, South Australia, Australia; East Melbourne, Victoria, Australia and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.