Clinical trial NCT05279300: A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Advanced Lymphoma
Lead sponsor: CStone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-03-15
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 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.

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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)
timeFrame: About 6 months
measure: Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part)
timeFrame: About 6 months
measure: Incident and severity of adverse events
timeFrame: Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
Secondary outcomes:
measure: Concentration of CS5001 total antibody, prodrug and the free cytotoxin
timeFrame: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
measure: Concentration of anti-CS5001 antibodies
timeFrame: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Other outcomes:
measure: Anti-tumor activity of CS5001 at RP2D in patient with selected advanced cancers (For dose expansion part)
timeFrame: About up to 12 months
Locations:
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates
state: New York
city: New York
country: United States
facility: Columbia U. - Herbert Irving Comprehensive Cancer Center
state: New York
city: Dallas
country: United States
facility: BUMC - Mary Crowley Cancer Research Centers (MCCRC)
state: Texas
city: Randwick
country: Australia
facility: Scientia Clinical Research Limited
state: New South Wales
city: Adelaide
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Adelaide
country: Australia
facility: Central Adelaide Local Health Network Incorporated
state: South Australia
city: Melbourne
country: Australia
facility: Epworth Foundation trading as Epworth HealthCare
state: Victoria
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital,
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Yanda Lu Dao Pei Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun YatSen University Cancer Center
state: Guang Dong
city: Guangzhou
country: China
facility: Guangdong Province Hospital
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumour Hospital
state: Guangxi
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu province hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Xi'an
country: China
facility: The first Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: