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

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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.
Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

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Study Stats
Protocol No.
21-001520
Category
Leukemia
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04227847
For detailed technical eligibility, visit ClinicalTrials.gov.