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Protocol # 20-035

Status

Recruiting

Description

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.

Condition

  • 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

  • CYT-0851
  • CYT-0851 in combination with gemcitabine
  • CYT-0851 in combination with capecitabine
  • CYT-0851 in combination with rituximab and bendamustine

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Part A: Incidence of dose limiting toxicity
  • Part B: Objective response rate
  • Part C: Incidence of dose limiting toxicity
  • Part D: Incidence of dose limiting toxicity
  • Part E: Incidence of dose limiting toxicity

Secondary Outcome:

  • Part A: Incidence of adverse events and other safety measures
  • Part C: Incidence of adverse events and other safety measures
  • Part D: Incidence of adverse events and other safety measures
  • Part E: Incidence of adverse events and other safety measures
  • Part A: Assessment of pharmacokinetic parameters
  • Part C: Assessment of pharmacokinetic parameters
  • Part D: Assessment of pharmacokinetic parameters
  • Part E: Assessment of pharmacokinetic parameters
  • Part B: Assessment of pharmacokinetic parameters
  • Part A: Objective response rate
  • Part C: Objective response rate
  • Part D: Objective response rate
  • Part E: Objective response rate
  • Part B: Anti-tumor activity and by DOR
  • Part B: Anti-tumor activity by PFS
  • Part B: Anti-tumor activity by DCR
  • Part B: Anti-tumor activity by OS
  • Part B: Safety assessment

Enrollment

320

Study Start Date

October 9, 2019

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Cyteir Therapeutics, Inc.

Source

Cyteir Therapeutics, Inc.

Official title

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

Clinicaltrials.gov Identifier

NCT03997968

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.