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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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 compared to azacitidine alone 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

Primary outcome measure(s)

• Number of participants with adverse events (AEs) — Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
  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.
• Number of participants with laboratory abnormalities — Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
  To be summarized using descriptive statistics.
• Number of participants with a dose-limiting toxicity (DLT) at each dose level (Parts A and D only) — Though end of DLT evaluation period; up to approximately 4 weeks
  To be summarized using descriptive statistics.

Trial sites (52)

+ 12 more sites — see the full list on the official registry below.