A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors
- Conditions
- Multiple MyelomaSoft Tissue SarcomaHead and Neck CancerNon-hodgkin LymphomaOvarian CancerDLBCLMalignancyMantle Cell LymphomaCLLSquamous Cell Carcinoma of Head and Neck
- Interventions
- Drug: CYT-0851 in combination with gemcitabineDrug: CYT-0851 in combination with capecitabineDrug: CYT-0851 in combination with rituximab and bendamustine
- Registration Number
- NCT03997968
- Lead Sponsor
- Cyteir Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 169
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CYT-0851 dose expansion CYT-0851 Part B: CYT-0851 administered orally at the selected Phase 2 dose for 28 day cycles CYT-0851 and rituximab and bendamustine CYT-0851 Part C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab on Day 1 and bendamustine on Days 1 and 2 of each 28 day cycle CYT-0851 and gemcitabine CYT-0851 in combination with gemcitabine Part D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine on Day 1, 8 and 15 of each 28 day cycle CYT-0851 and capecitabine CYT-0851 Part E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine on Days to 14 of each 21 day cycle CYT-0851 and capecitabine CYT-0851 in combination with capecitabine Part E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine on Days to 14 of each 21 day cycle CYT-0851 dose escalation CYT-0851 Part A: CYT-0851 administered orally in rising doses QD or BID for 28 day cycles CYT-0851 and rituximab and bendamustine CYT-0851 in combination with rituximab and bendamustine Part C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab on Day 1 and bendamustine on Days 1 and 2 of each 28 day cycle CYT-0851 and gemcitabine CYT-0851 Part D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine on Day 1, 8 and 15 of each 28 day cycle
- Primary Outcome Measures
Name Time Method Part B: Objective response rate 24 Weeks clinical benefit as determined by investigator assessments of tumor response
Part D: Incidence of dose limiting toxicity 28 Days Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose in combination with gemcitabine
Part E: Incidence of dose limiting toxicity 21 Days Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose in combination with capecitabine
Part A: Incidence of dose limiting toxicity 28 Days Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose
Part C: Incidence of dose limiting toxicity 28 Days Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose in combination with rituximab and bendamustine
- Secondary Outcome Measures
Name Time Method Part D: Objective response rate 24 months clinical activity as assessed by investigator assessment of objective response and duration of response
Part B: Anti-tumor activity by OS 24 months Antitumor activity as assessed by overall survival
Part C: Incidence of adverse events and other safety measures 28 Days incidence of adverse events changes in laboratory parameters, vital signs and ECGs
• Establish the PK of CYT-0851 Evaluate the type and frequency of adverse eventsPart C: Assessment of pharmacokinetic parameters Phase 1: 12 months Summarize PK parameters including Cmax, AUC and tmax
Part B: Anti-tumor activity by PFS 24 months Antitumor activity as assessed by progression free survival
Part D: Incidence of adverse events and other safety measures 28 Days incidence of adverse events changes in laboratory parameters, vital signs and ECGs
• Establish the PK of CYT-0851 Evaluate the type and frequency of adverse eventsPart D: Assessment of pharmacokinetic parameters Phase 1: 12 months Summarize PK parameters including Cmax, AUC and tmax
Part E: Assessment of pharmacokinetic parameters Phase 1: 12 months Summarize PK parameters including Cmax, AUC and tmax
Part A: Objective response rate 24 months clinical activity as assessed by investigator assessment of objective response and duration of response
Part A: Incidence of adverse events and other safety measures 28 Days incidence of adverse events changes in laboratory parameters, vital signs and ECGs
• Establish the PK of CYT-0851 Evaluate the type and frequency of adverse eventsPart E: Incidence of adverse events and other safety measures 21 Days incidence of adverse events changes in laboratory parameters, vital signs and ECGs
• Establish the PK of CYT-0851 Evaluate the type and frequency of adverse eventsPart C: Objective response rate 24 months clinical activity as assessed by investigator assessment of objective response and duration of response
Part B: Anti-tumor activity and by DOR 24 months Antitumor activity as assessed by duration of response
Part B: Safety assessment 24 months Safety as determined by incidence of AEs and SAEs and changes in laboratory, vitals and ECG findings
Part A: Assessment of pharmacokinetic parameters Phase 1: 12 months Summarize PK parameters including Cmax, AUC and tmax
Part B: Assessment of pharmacokinetic parameters Phase 1: 12 months Summarize PK parameters including Cmax, AUC and tmax
Part E: Objective response rate 24 months clinical activity as assessed by investigator assessment of objective response and duration of response
Part B: Anti-tumor activity by DCR 24 months Antitumor activity as assessed by disease control rate
Trial Locations
- Locations (16)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Stanford Comprehensive Cancer Center
🇺🇸Stanford, California, United States
Florida Cancer Specialists and Research Institute
🇺🇸Sarasota, Florida, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Washington Seattle Cancer Center
🇺🇸Seattle, Washington, United States
Oklahoma University-Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute at Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Sarah Cannon Research Institute at HealthONE
🇺🇸Denver, Colorado, United States
NYU Langone Health
🇺🇸New York, New York, United States
John Theurer Cancer Center at HUMC
🇺🇸Hackensack, New Jersey, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States