Spots Global Cancer Trial Database for A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
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Trial Identification
Brief Title: A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Official Title: A Phase 1 Study of SEA-CD70 in Myeloid Malignancies
Study ID: NCT04227847
Study Description
Brief Summary: This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer. This study will have six groups or "parts." * Part A will find out how much SEA-CD70 should be given to patients. * Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients with MDS. * Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients with AML. * Part D will find out how much SEA-CD70 with azacitidine should be given to patients. * Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat patients with MDS or MDS/AML that has not been treated. * Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat patients with MDS or MDS/AML.
Detailed Description: This is a phase 1, open-label, multicenter, dose-finding, and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of SEA-CD70 monotherapy and SEA-CD70 in combination with azacitidine in adults with myeloid malignancies. The study will be conducted in up to 6 parts. * Part A is a dose-escalation cohort designed to identify the MTD or recommended expansion dose of SEA-CD70 monotherapy in participants with relapsed/refractory (hypomethylating agent \[HMA\]-failure) MDS. * Part B is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsed/refractory (HMA-failure) MDS. * Part C is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsed/refractory AML. * Part D contains dose-finding/dose optimization cohorts designed to evaluate the safety/tolerability and identify the recommended expansion dose of SEA-CD70 in combination with azacitidine in participants with 1) relapsed/refractory (HMA-failure) MDS or MDS/AML, and 2) previously untreated higher-risk per IPSS-M (Moderate High, High or Very High) MDS or MDS/AML. * Part E is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with previously untreated higher-risk per IPSS-M (Moderate High, High, or Very High) MDS or MDS/AML. * Part F is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with relapsed/refractory (HMA-failure) MDS or MDS/AML.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
City of Hope, Duarte, California, United States
UCLA Department of Medicine - Hematology & Oncology, Los Angeles, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
University of Kansas Cancer Center, Fairway, Kansas, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Karmanos Cancer Institute / Wayne State University, Detroit, Michigan, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Columbia University Medical Center, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, The, Cleveland, Ohio, United States
James Cancer Hospital / Ohio State University, Columbus, Ohio, United States
Medical University of South Carolina/Hollings Cancer Center, Charleston, South Carolina, United States
Saint Francis Hospital / Bon Secours - South Carolina, Greenville, South Carolina, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology - Fort Worth, Dallas, Texas, United States
Houston Methodist Cancer Center, Houston, Texas, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Leids Universitair Medisch Centrum ( LUMC), Leiden, Other, Netherlands
University Medical Center (UMC) Utrecht, Utrecht, Other, Netherlands
Contact Details
Name: Juan Pinelli, PA-C, MMSc
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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