Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Cyteir Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: CYT-0851

Phase:

Phase 1/Phase 2

Eligibility


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

      6. Advanced small-cell lung 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 if required

   5. Histologically-proven B cell malignancies, meeting the following criteria: DLBCL, MCL,
   or Multiple Myeloma requiring therapy

   6. Histologically-proven solid tumors:

      1. Triple negative breast cancer

      2. Ovarian cancer

      3. Pancreatic cancer

      4. Soft tissue sarcoma

      5. Other biomarker positive cancers

Key Exclusion Criteria

   1. Known active brain metastases

   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) < 40 mL/min

      3. Hepatic function: AST > 2.0 x ULN; ALT > 2.0 x ULN;

      4. Total bilirubin > 1.5 x ULN;

      5. Albumin < 2.8 g/dL

   5. Screening QTc interval > 450 milliseconds (males) and > 470 ms for females

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mariel Rojas
1 650-723-0530
Recruiting