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
CStone Pharmaceuticals
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCS5001
The dose and dosing schedule is decided by the Safety Monitoring Committee.
- BiologicalRituximab
IV infusion
- DrugGemcitabine
IV infusion
- DrugOxaliplatin
IV infusion
- DrugLenalidomide
PO
- DrugCyclophosphamide
IV infusion
- DrugDoxorubicin
IV infusion
Locations (38)
- North Shore Hematology Oncology AssociatesEast Setauket, New York
- Columbia U. - Herbert Irving Comprehensive Cancer CenterNew York, New York
- BUMC - Mary Crowley Cancer Research Centers (MCCRC)Dallas, Texas
- Scientia Clinical Research LimitedRandwick, New South Wales
- Ashford Cancer Centre ResearchAdelaide, South Australia
- Central Adelaide Local Health Network IncorporatedAdelaide, South Australia