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

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SEA-CD70 — DRUG
  Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle
• azacitidine — DRUG
  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 — DRUG
  400 mg /day PO, continuously; administered with ramping

Study Details

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.

Key Dates

Start date

Aug 7, 2020

Status verified

Apr 2026

Primary completion

Jul 4, 2027

Completion

Jul 3, 2028

Study Design

Enrollment

178 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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

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 ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (49)

Find similar trials in Birmingham, AL

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