NCT03997968

A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors

A Multi-Center, Open Label Phase 1/2 Study of CYT-0851 in Patients With Relapsed/Refractory B-Cell Malignancies and Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Cyteir Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is an interventional, active-treatment, open-label, multi-center, Phase 1/2 study. The study objectives are to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose as a monotherapy and in combination with chemotherapy for evaluation in these patients.

Conditions

• Malignancy
• Non-hodgkin Lymphoma
• Multiple Myeloma
• Breast Cancer
• Ovarian Cancer
• Soft Tissue Sarcoma
• Head and Neck Cancer
• DLBCL
• Mantle Cell Lymphoma
• Follicular Lymphoma
• Pancreatic Cancer
• CLL
• Small Cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	CYT-0851	Part A and B: Daily oral doses of CYT-0851 for 28 day cycles
DRUG	CYT-0851 in combination with gemcitabine	Part D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine
DRUG	CYT-0851 in combination with capecitabine	Part E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine
DRUG	CYT-0851 in combination with rituximab and bendamustine	Part C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab and bendamustine

Timeline

• Start date: 2019-10-09
• Primary completion: 2024-11-30
• Completion: 2024-12-20
• First posted: 2019-06-25
• Last updated: 2024-12-24

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study