Recruiting
Phase 1

SEA-CD70

Sponsor:

Seagen, a wholly owned subsidiary of Pfizer

Code:

NCT04227847

Conditions

Myelodysplastic Syndrome

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SEA-CD70

azacitidine

Venetoclax

Study Details

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.

Conditions

Myelodysplastic Syndrome

Acute Myeloid Leukemia

Study ID

NCT04227847

Start date

Aug 7, 2020

Status verified date

Jul, 2026

Completion date

Jul 3, 2028

Anticipated

Primary completion date

Jul 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Part A Inclusion Criteria

  • 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

Part B Inclusion Criteria

  • 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

Part C Inclusion Criteria

  • 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
  • First CR duration <6 months
  • Adverse-risk per European Leukemia Network genetic risk stratification
  • Age 18-75 years
  • ECOG performance status of 0-2

Parts D and F Inclusion Criteria

  • Participants with diagnosis of MDS or MDS/AML (ICC 2022 criteria)
  • Disease which has relapsed, failed to respond after minimum of 6 cycles, or progressed following an HMA in the immediately preceding line of therapy.
  • Eligible for continued therapy with azacitidine
  • ECOG Performance Status 0-2

Parts D and E Inclusion Criteria

  • Participants with diagnosis of MDS or MDS/AML (ICC 2022 criteria), previously untreated.
  • Participants with higher-risk per IPSS-M MDS and MDS/AML
  • ECOG Performance Status 0-2

Part G Inclusion Criteria

  • Participants with diagnosis of AML (ICC 2022 criteria), previously untreated and ineligible for standard induction chemotherapy.
  • Age ≥18 years.
  • ECOG Performance Status of 0-2.

Exclusion Criteria (All Parts)

  • 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

Study Design

Enrollment

178 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A

SEA-CD70 dose escalation cohort in relapsed/refractory (HMA-failure) MDS

experimental: Part B

SEA-CD70 expansion cohort in relapsed/refractory (HMA-failure) MDS

experimental: Part C

SEA-CD70 expansion cohort in relapsed/refractory AML

experimental: Part D

SEA-CD70 + azacitidine dose-finding/dose optimization cohorts in relapsed/refractory MDS or MDS/AML, and previously untreated higher-risk MDS or MDS/AML

experimental: Part E

SEA-CD70 + azacitidine expansion cohort in previously untreated higher-risk MDS or MDS/AML

experimental: Part F

SEA-CD70 + azacitidine expansion cohort in relapsed/refractory MDS or MDS/AML

experimental: Part G

SEA-CD70 + azacitidine +venetoclax dose-finding/dose optimization in previously untreated and unfit for induction therapy AML

Interventions

SEA-CD70

Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle

azacitidine

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.

Venetoclax

400 mg /day PO, continuously; administered with ramping

Primary outcome measure

  • Number of participants with adverse events (AEs) [ Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years ]
  • Number of participants with laboratory abnormalities [ Time Frame: 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) [ Time Frame: Though end of DLT evaluation period; up to approximately 4 weeks ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Recruiting

Duarte, California, United States, 91010

IP Address: City of Hope Investigational Drug Services(IDS)

Recruiting

Duarte, California, United States, 91010

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

UCLA Hematology-Oncology Clinic

Recruiting

Los Angeles, California, United States, 90095

The University of Kansas Cancer Center ,Investigational Drug Services

Recruiting

Fairway, Kansas, United States, 66205

The University of Kansas Clinical Research Center

Recruiting

Fairway, Kansas, United States, 66205

The University of Kansas Hospital

Recruiting

Kansas City, Kansas, United States, 66160

University of Kansas Hospital Cambridge North Tower A

Recruiting

Kansas City, Kansas, United States, 66160

University of Kansas Medical center Medical office building

Recruiting

Kansas City, Kansas, United States, 66160

University of Kansas Medical Center Research Institute

Recruiting

Kansas City, Kansas, United States, 66160

The University of Kansas Cancer Center - Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

The University of Kansas Cancer Center - Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Norton Hospitals, Inc

Recruiting

Louisville, Kentucky, United States, 40202

Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD

Recruiting

Louisville, Kentucky, United States, 40207

Norton Cancer Institute, St. Matthews Campus

Recruiting

Louisville, Kentucky, United States, 40207

Norton Women & Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40207

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Dana Farber/Mass General Brigham Cancer Care, Inc

Recruiting

Boston, Massachusetts, United States, 02215

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Recruiting

Farmington Hills, Michigan, United States, 48334

The University of Kansas Cancer Center - Medical Oncology Clinic

Recruiting

Kansas City, Missouri, United States, 64116

The University of Kansas Cancer Center - Radiation Oncology Clinic

Recruiting

Kansas City, Missouri, United States, 64116

The University of Kansas Cancer Center -North

Recruiting

Kansas City, Missouri, United States, 64154

The University of Kansas Cancer Center - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

CUIMC Research Pharmacy

Recruiting

New York, New York, United States, 10032

The New York and Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

The Ohio State University Wexner Medical Center/James Cancer Hospital

Recruiting

Columbus, Ohio, United States, 43210

Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

Medical University of South Carolina- Ashley River Tower

Recruiting

Charleston, South Carolina, United States, 29425

Medical University of South Carolina- Investigational Drug Services

Recruiting

Charleston, South Carolina, United States, 29425

Medical University of South Carolina- University Hospital

Recruiting

Charleston, South Carolina, United States, 29425

Baylor Research Institute

Recruiting

Dallas, Texas, United States, 75204

Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy

Recruiting

Dallas, Texas, United States, 75246

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

More Information

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Seattle Genetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Seagen, a wholly owned subsidiary of Pfizer on 2026-07-22.