A Phase 1/2 Study of CYT-0851, an Oral RAD51 Inhibitor, in B-Cell Malignancies and Advanced Solid Tumors

Overview

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 the oral RAD51 inhibitor CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose for evaluation in these patients.

SparkCures ID 1046
Trial Phase Phase 1/2
Enrollment 165 Patients
Treatments
  • CYT-0851
Tags
  • RAD51 Inhibitor
Trial Sponsors
  • Cyteir Therapeutics, Inc.
NCT Identifier

NCT03997968

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Key Phase 1 Inclusion Criteria

  1. ECOG Performance Status of 0-1
  2. Measurable disease
  3. Willing to undergo a tumor biopsy
  4. Histologically-proven B cell malignancies, meeting the following criteria:
    1. Relapsed, refractory B-cell non-Hodgkin lymphoma requiring therapy
    2. Relapsed, refractory chronic lymphocytic leukemia requiring therapy
    3. Relapsed or progressive multiple myeloma on or after treatment
  5. Histologically-proven solid tumor meeting the following criteria:
    1. Metastatic breast cancer
    2. Recurrent squamous cell carcinoma of the head and neck
    3. Ovarian cancer
    4. Soft tissue sarcoma
    5. Recurrent metastatic or locally advanced pancreatic cancer

Key Phase 2 Inclusion Criteria

  1. ECOG Performance Status of 0-1
  2. Measurable disease defined by disease-specific response criteria
  3. Site of disease amenable to a biopsy and willing to undergo a biopsy
  4. Biomarker positive on recent biopsy or bone marrow sample
  5. Histologically-proven B cell malignancies, meeting the following criteria: DLBCL, MCL, or Multiple Myeloma requiring therapy
  6. Histologically-proven solid tumors: Triple Negative Breast Cancer, Ovarian Cancer or biomarker positive cancers

Key Exclusion Criteria

  1. Known history of brain metastases, unless treated (Phase 1 only) .
  2. Known history of meningeal involvement or meningeal carcinomatosis
  3. Spinal cord compression not definitively treated with surgery and/or radiation
  4. Laboratory assessments
    1. ANC < 1.0 x 10^9/L; PLT < 75 x 10^9/L; Hgb < 9.0 g/dL
    2. Calculated Creatinine clearance (Cockcroft-Gault) < 60 mL/min
    3. Hepatic function: AST > 2.0 x ULN; ALT > 2.0 x ULN; Total bilirubin > 1.5 ; Albumin < 2.8 g/dL
  5. Screening QTc interval > 450 milliseconds (males) and > 470 ms for females

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified John Theurer Cancer Center Hackensack Meridian Health
Verified Medical College of Wisconsin Froedtert Hospital

SparkCures Verified Accurate, up-to-date information. Learn more


Florida Cancer Specialists Sarasota Cattlemen

Sarasota, FL

Colorado
Florida
Florida Cancer Specialists Sarasota Cattlemen

Sarasota, FL

New Jersey
Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more

Pennsylvania
Tennessee
Texas
Washington
Wisconsin
Verified Medical College of Wisconsin Froedtert Hospital

SparkCures Verified Accurate, up-to-date information. Learn more

Resources

There are no resources, links or videos to display for this clinical trial.