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
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.

Colorado
Tennessee

Resources

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