A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
A Phase 1 Study of SEA-CD70 in Myeloid Malignancies
3 other identifiers
interventional
178
3 countries
54
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2020
Longer than P75 for phase_1
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2020
CompletedFirst Posted
Study publicly available on registry
January 14, 2020
CompletedStudy Start
First participant enrolled
August 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 3, 2028
March 16, 2026
March 1, 2026
6.9 years
January 10, 2020
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Number of participants with laboratory abnormalities
To be summarized using descriptive statistics.
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Number of participants with a dose-limiting toxicity (DLT) at each dose level (Parts A and D only)
To be summarized using descriptive statistics.
Though end of DLT evaluation period; up to approximately 4 weeks
Secondary Outcomes (20)
AUC - Area under the plasma concentration-time curve
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Tmax - Time to maximum concentration attained
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Cmax - Maximum observed plasma concentration
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Ctrough - Minimum plasma concentration per dosing interval
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
T1/2 - Terminal elimination half-life
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
- +15 more secondary outcomes
Study Arms (7)
Part A
EXPERIMENTALSEA-CD70 dose escalation cohort in relapsed/refractory (HMA-failure) MDS
Part B
EXPERIMENTALSEA-CD70 expansion cohort in relapsed/refractory (HMA-failure) MDS
Part C
EXPERIMENTALSEA-CD70 expansion cohort in relapsed/refractory AML
Part D
EXPERIMENTALSEA-CD70 + azacitidine dose-finding/dose optimization cohorts in relapsed/refractory MDS or MDS/AML, and previously untreated higher-risk MDS or MDS/AML
Part E
EXPERIMENTALSEA-CD70 + azacitidine expansion cohort in previously untreated higher-risk MDS or MDS/AML
Part F
EXPERIMENTALSEA-CD70 + azacitidine expansion cohort in relapsed/refractory MDS or MDS/AML
Part G
EXPERIMENTALSEA-CD70 + azacitidine +venetoclax dose-finding/dose optimization in previously untreated and unfit for induction therapy AML
Interventions
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle
75mg/m\^2 injected under the skin (SC; subcutaneous) or given into the vein (IV; intravenously) on Days 1 through 7 of each treatment cycle.
Eligibility Criteria
You may qualify if:
- Participants with cytologically/histologically confirmed MDS (2016 World Health Organization (WHO) classification) with
- Measurable disease per WHO MDS with excess blasts criteria
- MDS that is relapsed or refractory and must not have other therapeutic options
- Treatment failure after prior hypomethylating agent (HMA) therapy for MDS
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Participants with cytologically/histologically confirmed MDS (WHO classification) with:
- Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria
- MDS that is relapsed or refractory and must not have other therapeutic options
- Treatment failure after prior HMA therapy for MDS
- ECOG Performance Status of 0-2
- Participants with relapsed or refractory AML (ICC 2022) (except for acute promyelocytic leukemia \[APL\]):
- Who have received either 2 or 3 previous regimens
- Who have received 1 previous regimen to treat active disease and have at least one of the following:
- Age \> 60 and ≤75 years.
- Primary resistant AML or secondary AML
- +14 more criteria
You may not qualify if:
- Previous exposure to CD70-targeted agents
- Prior allogeneic hematopoietic stem cell transplant, for any condition
- Central nervous system leukemia
- History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura
- Parts D, F and G only: Prior oral HMA or oral HMA-combinations
- Part G: conditions that preclude enteral route of administration; concomitant use of strong/moderate CYP3A inducers; history of myeloproliferative neoplasm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Dept. of Medicine, UAB ONeal Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010, United States
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte, California, 91010, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA Hematology-Oncology Clinic
Los Angeles, California, 90095, United States
Colorado Blood Cancer Institute, Lab
Denver, Colorado, 80218, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian/St. Luke's Medical Center
Denver, Colorado, 80218, United States
The University of Kansas Cancer Center ,Investigational Drug Services
Fairway, Kansas, 66205, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205, United States
The University of Kansas Hospital
Kansas City, Kansas, 66160, United States
University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, 66160, United States
University of Kansas Medical center Medical office building
Kansas City, Kansas, 66160, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160, United States
The University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, 66210, United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, 66211, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Norton Hospitals, Inc
Louisville, Kentucky, 40202, United States
Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD
Louisville, Kentucky, 40207, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207, United States
Norton Women & Children's Hospital
Louisville, Kentucky, 40207, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber/Mass General Brigham Cancer Care, Inc
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
The University of Kansas Cancer Center - Medical Oncology Clinic
Kansas City, Missouri, 64116, United States
The University of Kansas Cancer Center - Radiation Oncology Clinic
Kansas City, Missouri, 64116, United States
The University of Kansas Cancer Center -North
Kansas City, Missouri, 64154, United States
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
CUIMC Research Pharmacy
New York, New York, 10032, United States
The New York and Presbyterian Hospital
New York, New York, 10032, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center/James Cancer Hospital
Columbus, Ohio, 43210, United States
Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Medical University of South Carolina- Ashley River Tower
Charleston, South Carolina, 29425, United States
Medical University of South Carolina- Investigational Drug Services
Charleston, South Carolina, 29425, United States
Medical University of South Carolina- University Hospital
Charleston, South Carolina, 29425, United States
Baylor Research Institute
Dallas, Texas, 75204, United States
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
Dallas, Texas, 75246, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Pharmacy - UMC Utrecht t.a.v. Apotheek KGO
Utrecht, 3584 CW, Netherlands
University Medical Center (UMC) Utrecht
Utrecht, 3584 CX, Netherlands
Related Publications (1)
Dewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3.
PMID: 37093350DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2020
First Posted
January 14, 2020
Study Start
August 7, 2020
Primary Completion (Estimated)
July 4, 2027
Study Completion (Estimated)
July 3, 2028
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.