Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Cyteir Therapeutics, Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Judson Englert, MD|
|Principal Investigator Affiliation||Cyteir Therapeutics|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|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|
Overexpression of activation-induced cytidine deaminase (AID) or other cytidine deaminases causes high rates of deoxyribonucleic acid (DNA) damage (mutations, double strand DNA breaks, and chromosome rearrangements) in a high number of patients with B-cell malignancies, such as NHL, MM, and CLL, and in a subset of patients with solid tumors, such as non-small cell lung cancer (NSCLC), sarcoma, breast cancer, ovarian cancer, and squamous cell carcinoma of the head and neck. Cancer cells that overexpress AID and other cytidine deaminases rely on RAD51, a protein involved in homologous recombination, to repair the DNA damage caused by cytidine deaminases. Inhibition of RAD51 with CYT-0851 in preclinical models induces cell death, tumor growth delay or tumor regression. The Phase 1 part of the study will follow an accelerated titration design, which includes enrollment of single patient cohorts until certain criteria are met, followed by a standard 3+3 design. This design will allow for identification of a recommended phase 2 dose (RP2D) level while dosing the least number of patients as possible at potentially sub-therapeutic doses. In the Phase 2 part of the study, preliminary efficacy will be evaluated in 8 expansion cohorts (total n = 92-220), using a Simon two-stage design. The RP2D will be selected based on the MTD, the safety profile, PK, and available pharmacodynamics data generated from all subjects in Phase 1. In both Phase 1 and Phase 2, patients will be treated in continuous 28-day cycles and all patients will be assessed for response every 2 cycles. Treatment will be terminated if the patient progresses, cannot tolerate treatment, or withdraws consent from active therapy. Patients will undergo a safety evaluation approximately 1 month (28-35 days) after the last dose. Patients will be followed for response until progression is documented.
Experimental: Experimental: Active treatment
This is an open label study. All patients will receive single agent CYT-0851 administered orally.
Drug: - CYT-0851
All patients will receive CYT-0851 as a single agent
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.