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

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS5001, an Anti-ROR1 Antibody Drug Conjugate, in Patients With Advanced Solid Tumors and Lymphomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279300
• Other study ID #: CS5001-101
• Status: Recruiting
• Phase: Phase 1
• Start date: March 28, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: CStone Pharmaceuticals
• Contact: Crystal Wang
• Phone: 021-60332435
• Email: wangjingru[@]cstonepharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug CS5001 in patients with advanced hematological and solid tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: June 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 dose expansion, pathologically confirmed Mantle Cell Lymphoma(MCL, following at least two prior lines of systemic therapy including Bruton Tyrosine Kinase inhibitors), Diffuse Large B Cell Lymphoma(DLBCL, following at least two prior lines of systemic therapies), and Triple Negative Breast Cancer(TNBC, following at least 2 lines of systemic therapy for advanced disease) will be enrolled.
• 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 or 1.
• Have adequate organ function.
• Is willing to provide tumor tissue and control blood sample.
• Female subjects of childbearing potential must have a negative serum pregnancy test.
• Both male and female subjects must be willing to use adequate contraception.

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.

Related Conditions & MeSH terms

• Advanced Lymphoma
• Advanced Solid Tumor
• Lymphoma

Intervention

Drug:
• CS5001
CS5001 will be administered every 3 weeks (21 days) by intravenous (IV) infusion, and 3 weeks (21 days) is considered as one treatment cycle.

Locations

Country	Name	City	State
Australia	Ashford Cancer Centre Research	Adelaide	South Australia
Australia	Scientia Clinical Research Limited	Randwick	New South Wales
China	Beijing Cancer Hospital	Beijing
China	Beijing Cancer Hospital	Beijing
China	Guangdong Province Hospital	Guangzhou	Guangdong
China	First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Provincial Hospital,	Hefei	Anhui
China	Shandong Cancer Hospital	Jinan	Shandong
China	Fudan University Shanghai Cancer Hospital	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan
United States	BUMC - Mary Crowley Cancer Research Centers (MCCRC)	Dallas	Texas
United States	North Shore Hematology Oncology Associates	East Setauket	New York
United States	Columbia U. - Herbert Irving Comprehensive Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
CStone Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-tumor activity of CS5001 at RP2D in patient with selected advanced cancers (For dose expansion part)		About up to 12 months
Primary	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).	About 6 months
Primary	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.	About 6 months
Primary	Incident and severity of adverse events		Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
Secondary	Concentration of CS5001 total antibody, prodrug and the free cytotoxin		Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Secondary	Concentration of anti-CS5001 antibodies		Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first