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

Overview

About this study

The purpose of this study is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Phase I:

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

Inclusion Criteria - Phase 2:

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

Exclusion Criteria:

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Grzegorz Nowakowski, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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Jacksonville, Fla.

Mayo Clinic principal investigator

Han Tun, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

-

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

-

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20490905

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