ICH GCP | Clinical Trials Registry

Seagen, a wholly owned subsidiary of Pfizer 

No

Yes

No

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

All

18 Years

N/A

No

Pfizer CT.gov Call Center

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Sponsor

C5781001

2023-506945-42-00

No

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Non-Randomized

Sequential Assignment

Parts B and C may enroll in parallel after enrollment of Part A is complete. Part D will enroll after Part A is complete. Parts E, F and Part G will enroll in parallel once Part D is complete.

Treatment

None (Open Label)