Acute Myeloid LeukemiaPhase 1NCT03144245
Study of AMV564 in Patients With AML
A Phase 1 study testing AMV564 and AMV564 in combination with pembrolizumab in people with Acute Myeloid Leukemia, run by Amphivena Therapeutics, Inc. at 10 sites in United States.
Trial summary
This is a first in human, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of AMV564. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- AMV564 and AMV564 in combination with pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 10 sitesUnited States
- Study dates
- 20 Mar 2017to 5 Nov 2020
- 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
- ≥ 18 years of age at the time of signing informed consent
- Diagnosis of AML according to the World Health Organization (WHO) 2008 criteria
- Relapsed or refractory disease meeting the following criteria:
- Primary refractory, ie, refractory to induction with a standard intensive anthracycline/cytarabine-based regimen or a non-intensive regimen (e.g., decitabine, azacytidine, low-dose cytarabine) for patients ineligible for an intensive anthracycline/cytarabine-based therapy
- First untreated relapse after a first CR lasting less than 12 months or first relapse refractory to salvage therapy regardless of length of first CR; or
- Second or later relapse. Relapse is defined as the reappearance of leukemic blasts in the peripheral blood or ≥ 5% leukemic blasts in the bone marrow after prior achievement of a CR or CRi.
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- OR Patients with newly diagnosed therapy-related AML, AML progressed from antecedent MDS or CMML treated with hypomethylating agents, or de novo AML with MDS-related cytogenetic abnormalities (per 2008 WHO criteria) and who are not candidates for (or decline) intensive remission induction therapy
- No more than 3 prior induction/salvage regimens to treat active disease, and no more than 1 prior stem cell transplant. Any number of continuous cycles of therapy with an individual hypomethylating agent count as one induction or salvage regimen.
- Blasts at least 5% in bone marrow
- Peripheral white blood cell (WBC) count: no upper limit at Screening, but must be < 10 x 109/L on Day 1 prior to treatment; patients with excessive blasts may be treated with hydroxyurea to bring counts down.
- Chemistry laboratory parameters within the following range:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x the upper limit of normal (ULN)
- Total bilirubin ≤ 1.5x the ULN; patients with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits.
- Creatinine clearance > 50 mL/min (measured or calculated by Cockcroft-Gault method)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients with ECOG score of 2 may be included, after discussion with the Sponsor Medical Monitor, if score is influenced by symptoms attributable to underlying AML disease.
- Willing to complete all scheduled visits and assessments at the institution administering therapy
- Able to read, understand and provide written informed consent
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study.
- History of, or known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ≥ 3 drug-related CNS toxicity
- Prior allogeneic transplant (dose escalation only)
- Prior solid organ transplantation
- Treatment with anti-thymocyte globulin (ATG) within 14 days prior to start date
- Treatment with any local or systemic antineoplastic therapy or radiation within 14 days prior to the initiation of AMV564 administration (hydroxyurea is exempted if used to reduce total WBC counts)
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- Clinically significant cardiac disease,
- Pulmonary, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements
- Evidence of active, uncontrolled, viral, bacterial, or systemic fungal infection. Prophylactic therapy according to institutional protocols is acceptable.
- Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)
- Active hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
- Second primary malignancy that has not been in remission for greater than 3 years. Exceptions that do not require a 3-year remission include: non-melanoma skin cancer; cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Papanicolaou (PAP) smear; localized prostate cancer (Gleason score < 6); or resected melanoma in situ.
- Major trauma or major surgery within 28 days prior to the initiation of AMV564 treatment
- Any serious underlying medical or psychiatric condition (e.g. alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the investigator would contraindicate the patient's participation in the study or confound the results of the study.
- Ability to become pregnant. However, female patients who have a negative serum or urine pregnancy test before enrollment and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom; intrauterine device and condom; diaphragm with spermicidal gel and condom) during the trial and for 90 days afterward (90 days after the end of AMV564 treatment) are considered eligible.
- Male patients with partners of childbearing potential.
- Pregnant or breastfeeding women
- Is a participant or plans to participate in another interventional clinical study, while taking part in this protocol. Participation in an observational study is acceptable.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Northwestern
Chicago, Illinois, 60611
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
New York Medical College
Hawthorne, New York, 10532
MD Anderson Cancer Center, The University of Texas
Houston, Texas, 70030-4009
Weill Cornell Medical College, The New York Presbyterian Hospital
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California, San Francisco
San Francisco, California, 94143
Fred Hutchinson Cancer Research
Seattle, Washington, 98109-1024
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1, First in Human, Open Label, Dose Escalation Study of AMV564, a CD33 x CD3 Tandem Diabody in Patients With Relapsed or Refractory Acute Myeloid Leukemia
This is a first in human, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of AMV564.
Read the detailed description
This study is a first in human, Phase 1, open label, multicenter, dose escalation study with expansion at the RP2D to evaluate the safety, tolerability and preliminary antileukemic activity of AMV564 in patients with relapsed or refractory acute myeloid leukemia (AML).
AMV564 will be given on Days 1-14 of a 4-week cycle, or Days 1-28 of a 6-week cycle,via CIV or subcutaneous administration for 1 or more treatment cycles as monotherapy or in combination with pembrolizumab.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- AMV564, AMV564 in combination with pembrolizumab
- Keywords
- AML, treatment, relapsed, refractory, phase 1
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMV564Biological
AMV564 for administration via continuous intravenous daily infusion or subcutaneous dosing
AMV564 in combination with pembrolizumabCombination product
AMV564 for administration via continuous intravenous daily infusion or subcutaneous dosing.in combination with pembrolizumab given IV every 21 days
| Study group | Role | What they receive |
|---|---|---|
| AMV564 | Experimental | Continuous infusion or subcutaneous dosing of AMV564 at increasing dose levels Receives: Biological: AMV564 |
| Combination AMV564 | Experimental | Continuous infusion or subcutaneous dosing of AMV564 at increasing dose levels in combination with pembrolizumab Receives: Combination Product: AMV564 in combination with pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation + expansion stage: incidence of all adverse events and serious adverse events (safety and tolerability)
Number of participants with adverse events as a measure of safety and tolerability.
Measured: 42 months
Expansion stage: Efficacy - Remission Rate
Proportion of participants who achieve complete remission, complete remission with incomplete recovery or partial remission
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start20 Mar 2017
- Primary completion21 Jul 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amphivena Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Chun, MD, Study director, Amphivena Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144245
- Sponsor's protocol ID
- AMV564-101
- Status last verified
- Oct 2021
- First submitted
- 25 Apr 2017
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First in Human, Open Label, Dose Escalation Study of AMV564, a CD33 x CD3 Tandem Diabody in Patients With Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03144245
- Acronym / sponsor ID
- AMV564-101
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, treatment, relapsed, refractory, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Amphivena Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 8 May 2017 (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 is a first in human, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of AMV564.
Detailed description
This study is a first in human, Phase 1, open label, multicenter, dose escalation study with expansion at the RP2D to evaluate the safety, tolerability and preliminary antileukemic activity of AMV564 in patients with relapsed or refractory acute myeloid leukemia (AML).
AMV564 will be given on Days 1-14 of a 4-week cycle, or Days 1-28 of a 6-week cycle,via CIV or subcutaneous administration for 1 or more treatment cycles as monotherapy or in combination with pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMV564 | Experimental | Biological: AMV564Continuous infusion or subcutaneous dosing of AMV564 at increasing dose levels |
| Combination AMV564 | Experimental | Combination Product: AMV564 in combination with pembrolizumabContinuous infusion or subcutaneous dosing of AMV564 at increasing dose levels in combination with pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- ≥ 18 years of age at the time of signing informed consent
- Diagnosis of AML according to the World Health Organization (WHO) 2008 criteria
- Relapsed or refractory disease meeting the following criteria:
- OR Patients with newly diagnosed therapy-related AML, AML progressed from antecedent MDS or CMML treated with hypomethylating agents, or de novo AML with MDS-related cytogenetic abnormalities (per 2008 WHO criteria) and who are not candidates for (or decline) intensive remission induction therapy
- No more than 3 prior induction/salvage regimens to treat active disease, and no more than 1 prior stem cell transplant. Any number of continuous cycles of therapy with an individual hypomethylating agent count as one induction or salvage regimen.
Key exclusion criteria (18 listed)
- Patients who meet any of the following criteria will be excluded from the study.
- History of, or known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ≥ 3 drug-related CNS toxicity
- Prior allogeneic transplant (dose escalation only)
- Prior solid organ transplantation
- Treatment with anti-thymocyte globulin (ATG) within 14 days prior to start date
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 |
|---|---|---|
| AMV564AMV564 for administration via continuous intravenous daily infusion or subcutaneous dosing | Biological | AMV564 |
| AMV564 in combination with pembrolizumabAMV564 for administration via continuous intravenous daily infusion or subcutaneous dosing.in combination with pembrolizumab given IV every 21 days | Combination product | Combination AMV564 |
Primary outcome
Dose escalation + expansion stage: incidence of all adverse events and serious adverse events (safety and tolerability)
Time frame: 42 months
Number of participants with adverse events as a measure of safety and tolerability.
Expansion stage: Efficacy - Remission Rate
Time frame: 42 months
Proportion of participants who achieve complete remission, complete remission with incomplete recovery or partial remission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- 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.
Patrick Chun, MD study director
Amphivena Therapeutics, Inc.
10 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 AMV564 and AMV564 in combination with pembrolizumab in people with Acute Myeloid Leukemia, run by Amphivena Therapeutics, Inc. at 10 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 17 inclusion and 18 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: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose escalation + expansion stage: incidence of all adverse events and serious adverse events (safety and tolerability) (time frame: 42 months). 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?
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 12 Oct 2021.