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
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.
Arms & 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
- DrugVincristine
IV infusion
- DrugPrednisone
PO
Outcome measures
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).
Time frame: About 6 months
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.
Time frame: About 6 months
Incident and severity of adverse events
Time frame: Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
Objective Response Rate (ORR) (for dose expansion)
The percentage of participants with a CR or PR based on 2014 Lugano Classification Criteria for lymphomas, iwCLL 2018 guidelines for CLL/SLL and RECIST v1.1 for solid tumors.
Time frame: Up to 2 years
Secondary
Concentration of CS5001 total antibody
Time frame: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Concentration of anti-CS5001 antibodies
Time frame: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Eligibility criteria
Study locations (3)
North Shore Hematology Oncology Associates
East Setauket, New York, 11733
Columbia U. - Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
BUMC - Mary Crowley Cancer Research Centers (MCCRC)
Dallas, Texas, 75201-7307