NCT05279300

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: CStone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor
• Advanced Lymphoma

Interventions

Type	Name	Description
DRUG	CS5001	The dose and dosing schedule is decided by the Safety Monitoring Committee.
BIOLOGICAL	Rituximab	IV infusion
DRUG	Gemcitabine	IV infusion
DRUG	Oxaliplatin	IV infusion
DRUG	Lenalidomide	PO
DRUG	Cyclophosphamide	IV infusion
DRUG	Doxorubicin	IV infusion
DRUG	Vincristine	IV infusion
DRUG	Prednisone	PO

Timeline

• Start date: 2022-03-28
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2022-03-15
• Last updated: 2025-08-11

Locations

38 sites across 3 countries: United States, Australia, China

Regulatory

• FDA-regulated drug study