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

ConditionsMyelodysplastic Syndrome Acute Myeloid Leukemia

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorSeagen, a wholly owned subsidiary of Pfizer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

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

Treatment groups

178 Participants

are divided into 7 treatment groups

Treatment groups

See each treatment group below.

Group A: Part AExperimental treatment 1 intervention

Group B: Part BExperimental treatment 1 intervention

Group C: Part CExperimental treatment 1 intervention

Group D: Part DExperimental treatment 2 interventions

Group E: Part EExperimental treatment 2 interventions

Group F: Part FExperimental treatment 2 interventions

Group G: Part GExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years

Number of participants with laboratory abnormalities