Acute Myeloid LeukemiaPhase 1NCT04755244
A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
A Phase 1 study testing evorpacept, venetoclax and azacitidine in people with Acute Myeloid Leukemia and AML, Adult, run by ALX Oncology Inc. at 5 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, AML, Adult
- What is being tested?
- evorpacept, venetoclax and azacitidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 May 2021to 16 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Venetoclax and Azacitidine in Patients With Acute Myeloid Leukemia (AML) (ASPEN-05)
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).
Read the detailed description
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. While intended to be a Phase 1/2 clinical study, the study never moved forward to Phase 2.
- Conditions
- Acute Myeloid Leukemia, AML, Adult
- Being tested
- evorpacept, venetoclax, azacitidine
- Keywords
- ALX148, CD47, SIRPalpha, azacitidine, venetoclax, evorpacept
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evorpaceptDrug
Also called ALX148
Fusion protein that blocks CD47-SIRPalpha pathway
venetoclaxDrug
Also called Venclexta
BCL-2 inhibitor
azacitidineDrug
Also called Vidaza
Hypomethylating agent (HMA)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: evorpacept; Drug: venetoclax; Drug: azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Dose Limiting Toxicities (DLT)
Number of participants with a DLT
Measured: Up to 28 days
Phase 2: Composite complete remission rate (CRc)
Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start5 May 2021
- Primary completion5 May 2023
- Study completion16 Aug 2023
Why it stopped: While intended to be a Phase 1/2 clinical study, the study never moved forward to Phase 2.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALX Oncology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755244
- Sponsor's protocol ID
- AT148005
- Status last verified
- Aug 2023
- First submitted
- 11 Feb 2021
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marks JA, Wang X, Fenu EM, Bagg A, Lai C. TP53 in AML and MDS: The new (old) kid on the block. Blood Rev. 2023 Jul;60:101055. doi: 10.1016/j.blre.2023.101055. Epub 2023 Feb 14.
PubMed 36841672
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Venetoclax and Azacitidine in Patients With Acute Myeloid Leukemia (AML) (ASPEN-05)
- ClinicalTrials.gov ID
- NCT04755244
- Acronym / sponsor ID
- AT148005
- Conditions
- Acute Myeloid Leukemia, AML, Adult
- Keywords
- ALX148, CD47, SIRPalpha, azacitidine, venetoclax, evorpacept
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: While intended to be a Phase 1/2 clinical study, the study never moved forward to Phase 2.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ALX Oncology Inc.Industry (pharma, biotech, devices)
- Study start
- 5 May 2021 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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. While intended to be a Phase 1/2 clinical study, the study never moved forward to Phase 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| evorpacept (ALX148) + venetoclax + azacitidine | Experimental | Drug: evorpacept, Drug: venetoclax, Drug: azacitidinePhase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evorpaceptAlso: ALX148Fusion protein that blocks CD47-SIRPalpha pathway | Drug | evorpacept (ALX148) + venetoclax + azacitidine |
| venetoclaxAlso: VenclextaBCL-2 inhibitor | Drug | evorpacept (ALX148) + venetoclax + azacitidine |
| azacitidineAlso: VidazaHypomethylating agent (HMA) | Drug | evorpacept (ALX148) + venetoclax + azacitidine |
Primary outcome
Phase 1: Dose Limiting Toxicities (DLT)
Time frame: Up to 28 days
Number of participants with a DLT
Phase 2: Composite complete remission rate (CRc)
Time frame: Approximately 6 months
Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria
Results and safety
The study was stopped early (reason given: While intended to be a Phase 1/2 clinical study, the study never moved forward to Phase 2.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Derived from this study: PubMed 36841672Marks JA, Wang X, Fenu EM, Bagg A, Lai C. TP53 in AML and MDS: The new (old) kid on the block. Blood Rev. 2023 Jul;60:101055. doi: 10.1016/j.blre.2023.101055. Epub 2023 Feb 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing evorpacept, venetoclax and azacitidine in people with Acute Myeloid Leukemia and AML, Adult, run by ALX Oncology Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: While intended to be a Phase 1/2 clinical study, the study never moved forward to Phase 2.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Dose Limiting Toxicities (DLT) (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.