Search Cancer Clinical Trials
Recruiting
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 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 AML.
- Myelodyspastic Syndrome
- Acute Myeloid Leukemia
- SEA-CD70
- azacitidine
Phase 1
Interventional
Primary Outcome:
- Number of participants with adverse events (AEs)
- Number of participants with laboratory abnormalities
- Number of participants with a dose-limiting toxicity (DLT) at each dose level (Parts A and D only)
Secondary Outcome:
- AUC - Area under the plasma concentration-time curve
- Tmax - Time to maximum concentration attained
- Cmax - Maximum observed plasma concentration
- Ctrough - Minimum plasma concentration per dosing interval
- T1/2 - Terminal elimination half-life
- Incidence of antidrug antibodies (ADA)
- Complete remission (CR) Rate
- Complete remission with incomplete blood count recovery (CRi) rate
- Complete remission with partial hematologic recovery (CRh) rate
- Hematologic response (HI) rate
- Overall response rate (ORR)
- Blast clearance rate for participants with MDS
- Duration of remission (DOR)
- Overall survival (OS)
- Event-free survival (EFS)
- MRD-negative ORR
- Time to response (TTR)
- Rate of conversion to transfusion independence (TI)
- Rate of TI maintenance
140
August 7, 2020
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Seagen Inc.
Seagen Inc.
A Phase 1 Study of SEA-CD70 in Myeloid Malignancies
NCT04227847
Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.