A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies

Description

This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants 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 seven groups or "parts." * Part A will find out how much SEA-CD70 should be given to participants * Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants 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 participants with AML. * Part D will find out how much SEA-CD70 with azacitidine should be given to participants * 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 participants 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 participants with MDS or MDS/AML. * Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.

Conditions

Myelodysplastic Syndrome, Acute Myeloid Leukemia

Study Overview

Study Details

Study overview

This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants 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 seven groups or "parts." * Part A will find out how much SEA-CD70 should be given to participants * Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants 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 participants with AML. * Part D will find out how much SEA-CD70 with azacitidine should be given to participants * 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 participants 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 participants with MDS or MDS/AML. * Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies

Condition
Myelodysplastic Syndrome
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35249

Birmingham

ONeal Comprehensive Cancer Center at UAB, Birmingham, Alabama, United States, 35294

Duarte

City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States, 91010

Duarte

IP Address: City of Hope Investigational Drug Services(IDS), Duarte, California, United States, 91010

Los Angeles

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States, 90095

Los Angeles

UCLA Department of Medicine - Hematology & Oncology, Los Angeles, California, United States, 90095

Los Angeles

UCLA Hematology-Oncology Clinic, Los Angeles, California, United States, 90095

Denver

Colorado Blood Cancer Institute, Lab, Denver, Colorado, United States, 80218

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Seagen, a wholly owned subsidiary of Pfizer,

    Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

    Study Record Dates

    2027-04-15