Description:
This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia (AML).
This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia (AML).
Recruiting
Phase 1/Phase 2
Drug | Synonyms | Arms |
---|---|---|
evorpacept | ALX148 | evorpacept (ALX148) + venetoclax + azacitidine |
venetoclax | Venclexta | evorpacept (ALX148) + venetoclax + azacitidine |
azacitidine | Vidaza | evorpacept (ALX148) + venetoclax + azacitidine |
The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with venetoclax and azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of evorpacept (ALX148) in combination with venetoclax and azacitidine. The Phase 2 will evaluate the efficacy of evorpacept (ALX148) in combination with venetoclax and azacitidine for patients with AML.
Name | Type | Description | Interventions |
---|---|---|---|
evorpacept (ALX148) + venetoclax + azacitidine | Experimental | Phase 1a: Participants will receive escalating doses of evorpacept (ALX148) in combination with venetoclax and azacitidine Phase 1b/2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with venetoclax and azacitidine |
|
Inclusion Criteria: - Cytologically or histologically confirmed diagnosis of relapsed/refractory or newly diagnosed AML per WHO 2016 classification. - Phase 1a: AML that is relapsed/refractory or that is previously untreated in patients not considered suitable for intensive induction therapy. - Phase 1b: AML that is relapsed/refractory after prior treatment with a HMA-based regimen. - Phase 2: Previously untreated AML in patients who are not considered suitable candidates for intensive induction therapy. - Adequate renal and liver function. - Age ≥18 years. - Adequate performance status. Exclusion Criteria: - In Phase 1a and 1b, patients that have undergone prior allo-HSCT must be at least 3 months post-HSCT, without uncontrolled graft-versus-host disease (GVHD). For Phase 2, patients that have undergone prior allo-HSCT are excluded. - Patients with newly diagnosed AML with favorable risk cytogenetics such as t(8;21), inv(16), or t(16;16) as per the NCCN Guidelines Version 3, 2019 for AML. - Patients with acute promyelocytic leukemia (APL). - Prior treatment with any anti-CD47 or anti-SIRPalpha (signal regulatory protein alpha) agent. - Known active viral infections, including hepatitis B and C, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) related illness, or SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Phase 1: Dose Limiting Toxicities (DLT) |
Time Frame: | Up to 28 days |
Safety Issue: | |
Description: | Number of participants with a DLT |
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | ALX Oncology Inc. |
August 25, 2021