Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04227847
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2020-01-10
Brief Title:
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase 1 Study of SEA-CD70 in Myeloid Malignancies
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will look at a drug called SEA-CD70 with and without azacitidine to find out if it is safe for patients 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 six groups or parts
Part A will find out how much SEA-CD70 should be given to patients
Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients 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 patients with AML
Part D will find out how much SEA-CD70 with azacitidine should be given to patients
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 patients with MDS or MDSAML 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 patients with MDS or MDSAML
This study will have six groups or parts
Part A will find out how much SEA-CD70 should be given to patients
Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients 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 patients with AML
Part D will find out how much SEA-CD70 with azacitidine should be given to patients
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 patients with MDS or MDSAML 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 patients with MDS or MDSAML
Detailed Description:
This is a phase 1 open-label multicenter dose-finding and dose expansion study designed to evaluate the safety tolerability pharmacokinetics PK and antitumor activity of SEA-CD70 monotherapy and SEA-CD70 in combination with azacitidine in adults with myeloid malignancies The study will be conducted in up to 6 parts
Part A is a dose-escalation cohort designed to identify the MTD or recommended expansion dose of SEA-CD70 monotherapy in participants with relapsedrefractory hypomethylating agent HMA-failure MDS
Part B is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsedrefractory HMA-failure MDS
Part C is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsedrefractory AML
Part D contains dose-findingdose optimization cohorts designed to evaluate the safetytolerability and identify the recommended expansion dose of SEA-CD70 in combination with azacitidine in participants with 1 relapsedrefractory HMA-failure MDS or MDSAML and 2 previously untreated higher-risk per IPSS-M Moderate High High or Very High MDS or MDSAML
Part E is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with previously untreated higher-risk per IPSS-M Moderate High High or Very High MDS or MDSAML
Part F is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with relapsedrefractory HMA-failure MDS or MDSAML
Part A is a dose-escalation cohort designed to identify the MTD or recommended expansion dose of SEA-CD70 monotherapy in participants with relapsedrefractory hypomethylating agent HMA-failure MDS
Part B is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsedrefractory HMA-failure MDS
Part C is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsedrefractory AML
Part D contains dose-findingdose optimization cohorts designed to evaluate the safetytolerability and identify the recommended expansion dose of SEA-CD70 in combination with azacitidine in participants with 1 relapsedrefractory HMA-failure MDS or MDSAML and 2 previously untreated higher-risk per IPSS-M Moderate High High or Very High MDS or MDSAML
Part E is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with previously untreated higher-risk per IPSS-M Moderate High High or Very High MDS or MDSAML
Part F is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with relapsedrefractory HMA-failure MDS or MDSAML
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-001917-18 | EUDRACT_NUMBER | None | None |