Acute Myeloid LeukemiaPhase 1NCT03106428
A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
A Phase 1 study testing MEDI7247 in people with Acute Myeloid Leukemia and Multiple Myeloma, run by MedImmune LLC at 14 sites in 3 countries.
Trial summary
To assess safety and tolerability, describe the dose-limiting toxicities, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected hematological… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Myeloid Leukemia, Multiple Myeloma, Diffuse Large B-cell Lymphoma
- What is being tested?
- MEDI7247
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 29 Mar 2017to 3 Jan 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed relapsed/refractory diagnosis of select hematologic malignancies for which no standard/salvage therapies are available.
- Age ≥ 18 years at the time of screening.
- Written informed consent and any locally required authorization
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Liver Function Tests: AST and ALT ≤ 3 × ULN, and serum TBL ≤ 1.5 × ULN, unless consistent with Gilbert's syndrome for which TBL ≤ 2.5 × ULN is allowed.
- 5. CrCL ≥ 40 mL/min 6. Female patients of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from 7 days post-screening, and must agree to continue using such precautions for 90 days after the last dose of investigational product.
- 7. Nonsterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from 7 days post-screening and for 90 days after receipt of the last dose of investigational product.
Who cannot join
- Received cytotoxic chemotherapy within 21 days (or 42 days for nitrosureas or mitomycin C) prior to the first scheduled dose of MEDI7247.
- Received major surgery (as defined by the Investigator), radiotherapy, or immunotherapy (including immune checkpoint inhibitors and adoptive cellular therapy such as autologous or donor NK cell or T lymphocyte infusions (e.g. CAR -T cells)) within 28 days of the first scheduled dose of MEDI7247.
- Received an investigational drug within 14 days of the first scheduled dose of MEDI7247 or not recovered from associated toxicities.
- Patients who have previously received an autologous SCT, are excluded if less than 120 days have elapsed from the time of transplant or the patient has not recovered from transplant-associated toxicities prior to the first scheduled dose of MEDI7247.
- History of liver cirrhosis, liver fibrosis or prior liver irradiation regardless of the time interval (not including total body irradiation administered during allogeneic SCT).
- Failure to recover from all prior treatment-related non-hematological toxicities to ≤ Grade 1 prior to the first scheduled dose of MEDI7247 (except for alopecia and neuropathy).
Show all 10Show fewer
- Patients at risk of non-disease related major bleeding (eg, recent GI hemorrhage or neurosurgery, within previous 21 days).
- Current severe active systemic disease including active concurrent malignancy
- Central nervous system (CNS) disease that is untreated, symptomatic, or requires therapy to control symptoms.
- Active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections at the time of screening.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States10 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Boston, Massachusetts, 02114
Research Site
Chicago, Illinois, 60611
Research Site
Denver, Colorado, 80218
Research Site
Greer, South Carolina, 29650
Research Site
Los Angeles, California, 90095
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10065
Research Site
San Antonio, Texas, 78229
Research Site
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
To assess safety and tolerability, describe the dose-limiting toxicities, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are refractory to prior standard therapy, and for whom there is no standard salvage regimen available.
- Being tested
- MEDI7247
- Keywords
- MEDI7247, Acute Myeloid Leukemia, Multiple Myeloma, Diffuse Large B-cell Lymphoma, AML, MM, DLBCL
- Medical subject headings
- Leukemia, Myeloid, Acute, Multiple Myeloma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI7247Drug
The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV
| Study group | Role | What they receive |
|---|---|---|
| acute myeloid leukemia | Experimental | Patients with R/R AML by World Health Organization (WHO) classification (Arber et al, 2016) who have failed prior standard therapy and for whom no standard therapies are available Receives: Drug: MEDI7247 |
| Multiple Myeloma | Experimental | Patients with R/R MM who have failed prior standard therapy(ies) which should include immunomodulatory agents and proteasome inhibitors and for whom there is no standard salvage regimen. Receives: Drug: MEDI7247 |
| Diffuse Large B-cell Lymphoma | Experimental | Patients with R/R DLBCL who have failed prior standard therapy(ies) and for whom there is no standard salvage regimen. Receives: Drug: MEDI7247 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AEs)
To assess by the occurrence of adverse events (AEs)
Measured: From time of informed consent through 90 days post end of treatment
Occurrence of serious adverse events (SAEs)
To assess by the occurrence of serious adverse events (SAEs)
Measured: From time of informed consent through 90 days post end of treatment
Occurrence of dose-limiting toxicities (DLTs)
To assess by the occurrence of non-Hematologic and hematologic toxicities, AEs, and abnormal laboratory results.
Measured: During the evaluation period of 21 or 42 days post-first dose
Number of patients with changes in laboratory parameters from baseline
To assess serum chemistry, hematology, Coagulation and urinalysis
Measured: From time of informed consent and up to 21 days post end of treatment
Number of patients with changes in vital signs from baseline
To assess body temperature, blood pressure, and heart rate
Measured: From time of informed consent and up to 21 days post end of treatment
Number of patients with changes in electrocardiogram (ECG) results from baseline
To assess using twelve-lead ECG recordings
Measured: From time of informed consent and up to 21 days post end of treatment
Percentage of patients with changes in laboratory parameters from baseline
To assess serum chemistry, hematology, Coagulation and urinalysis
Measured: From time of informed consent and up to 21 days post end of treatment
Secondary outcomes (11)
MEDI7247 maximum observed concentration for PK
To assess the Pharmacokinetics of MEDI7247
Measured: From time of informed consent through 30 days post end of treatment
MEDI7247 area under the concentration-time curve for PK
To assess the Pharmacokinetics of MEDI7247
Measured: From time of informed consent through 30 days post end of treatment
MEDI7247 clearance for PK
To assess the Pharmacokinetics of MEDI7247
Measured: From time of informed consent through 30 days post end of treatment
MEDI7247 terminal half-life for PK
To assess the Pharmacokinetics of MEDI7247
Measured: From time of informed consent through 30 days post end of treatment
Number of subjects who develop anti-drug antibodies (ADAs)
To assess the immunogenicity of MEDI7247
Measured: From time of informed consent through 30 days post end of treatment
Best overall response (BOR)
To assess the anti-tumor activity of MEDI7247
Measured: From time of informed consent and up to 3 years after final patient is enrolled
Objective response rate (ORR)
To assess the anti-tumor activity of MEDI7247
Measured: From time of informed consent and up to 3 years after final patient is enrolled
Time to response (TTR)
To assess the anti-tumor activity of MEDI7247
Measured: From time of informed consent and up to 3 years after final patient is enrolled
Duration of response (DoR)
To assess the anti-tumor activity of MEDI7247
Measured: From time of informed consent and up to 3 years after final patient is enrolled
Progression-free survival (PFS)
To assess the anti-tumor activity of MEDI7247
Measured: From time of informed consent and up to 3 years after final patient is enrolled
Overall survival (OS)
To assess the anti-tumor activity of MEDI7247
Measured: From time of informed consent and up to 3 years after final patient is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start29 Mar 2017
- Primary completion3 Jan 2020
- Study completion3 Jan 2020
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106428
- Sponsor's protocol ID
- D8540C00001
- Status last verified
- Feb 2020
- First submitted
- 29 Mar 2017
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maris M, Salles G, Kim WS, Kim TM, Lyons RM, Arellano M, Karmali R, Schiller G, Cull E, Abboud CN, Batlevi C, Kagiampakis I, Rebelatto MC, Lee Y, Kirby LC, Wang F, Bothos J, Townsley DM, Fathi AT, Ribrag V. ASCT2-Targeting Antibody-Drug Conjugate MEDI7247 in Adult Patients with Relapsed/Refractory Hematological Malignancies: A First-in-Human, Phase 1 Study. Target Oncol. 2024 May;19(3):321-332. doi: 10.1007/s11523-024-01054-z. Epub 2024 Apr 29.
PubMed 38683495
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
- ClinicalTrials.gov ID
- NCT03106428
- Acronym / sponsor ID
- D8540C00001
- Keywords
- MEDI7247, Acute Myeloid Leukemia, Multiple Myeloma, Diffuse Large B-cell Lymphoma, AML, MM, DLBCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 10 Apr 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.
To assess safety and tolerability, describe the dose-limiting toxicities, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are refractory to prior standard therapy, and for whom there is no standard salvage regimen available.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acute myeloid leukemia | Experimental | Drug: MEDI7247Patients with R/R AML by World Health Organization (WHO) classification (Arber et al, 2016) who have failed prior standard therapy and for whom no standard therapies are available |
| Multiple Myeloma | Experimental | Drug: MEDI7247Patients with R/R MM who have failed prior standard therapy(ies) which should include immunomodulatory agents and proteasome inhibitors and for whom there is no standard salvage regimen. |
| Diffuse Large B-cell Lymphoma | Experimental | Drug: MEDI7247Patients with R/R DLBCL who have failed prior standard therapy(ies) and for whom there is no standard salvage regimen. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed relapsed/refractory diagnosis of select hematologic malignancies for which no standard/salvage therapies are available.
- Age ≥ 18 years at the time of screening.
- Written informed consent and any locally required authorization
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Liver Function Tests: AST and ALT ≤ 3 × ULN, and serum TBL ≤ 1.5 × ULN, unless consistent with Gilbert's syndrome for which TBL ≤ 2.5 × ULN is allowed.
Key exclusion criteria (10 listed)
- Received cytotoxic chemotherapy within 21 days (or 42 days for nitrosureas or mitomycin C) prior to the first scheduled dose of MEDI7247.
- Received major surgery (as defined by the Investigator), radiotherapy, or immunotherapy (including immune checkpoint inhibitors and adoptive cellular therapy such as autologous or donor NK cell or T lymphocyte infusions (e.g. CAR -T cells)) within 28 days of the first scheduled dose of MEDI7247.
- Received an investigational drug within 14 days of the first scheduled dose of MEDI7247 or not recovered from associated toxicities.
- Patients who have previously received an autologous SCT, are excluded if less than 120 days have elapsed from the time of transplant or the patient has not recovered from transplant-associated toxicities prior to the first scheduled dose of MEDI7247.
- History of liver cirrhosis, liver fibrosis or prior liver irradiation regardless of the time interval (not including total body irradiation administered during allogeneic SCT).
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 |
|---|---|---|
| MEDI7247The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV | Drug | Diffuse Large B-cell Lymphoma, Multiple Myeloma, acute myeloid leukemia |
Primary outcome
Occurrence of adverse events (AEs)
Time frame: From time of informed consent through 90 days post end of treatment
To assess by the occurrence of adverse events (AEs)
Occurrence of serious adverse events (SAEs)
Time frame: From time of informed consent through 90 days post end of treatment
To assess by the occurrence of serious adverse events (SAEs)
Occurrence of dose-limiting toxicities (DLTs)
Time frame: During the evaluation period of 21 or 42 days post-first dose
To assess by the occurrence of non-Hematologic and hematologic toxicities, AEs, and abnormal laboratory results.
Number of patients with changes in laboratory parameters from baseline
Time frame: From time of informed consent and up to 21 days post end of treatment
To assess serum chemistry, hematology, Coagulation and urinalysis
Number of patients with changes in vital signs from baseline
Time frame: From time of informed consent and up to 21 days post end of treatment
To assess body temperature, blood pressure, and heart rate
Number of patients with changes in electrocardiogram (ECG) results from baseline
Time frame: From time of informed consent and up to 21 days post end of treatment
To assess using twelve-lead ECG recordings
Percentage of patients with changes in laboratory parameters from baseline
Time frame: From time of informed consent and up to 21 days post end of treatment
To assess serum chemistry, hematology, Coagulation and urinalysis
11 secondary outcomes
MEDI7247 maximum observed concentration for PK
Time frame: From time of informed consent through 30 days post end of treatment
MEDI7247 area under the concentration-time curve for PK
Time frame: From time of informed consent through 30 days post end of treatment
MEDI7247 clearance for PK
Time frame: From time of informed consent through 30 days post end of treatment
MEDI7247 terminal half-life for PK
Time frame: From time of informed consent through 30 days post end of treatment
Number of subjects who develop anti-drug antibodies (ADAs)
Time frame: From time of informed consent through 30 days post end of treatment
Best overall response (BOR)
Time frame: From time of informed consent and up to 3 years after final patient is enrolled
Objective response rate (ORR)
Time frame: From time of informed consent and up to 3 years after final patient is enrolled
Time to response (TTR)
Time frame: From time of informed consent and up to 3 years after final patient is enrolled
Duration of response (DoR)
Time frame: From time of informed consent and up to 3 years after final patient is enrolled
Progression-free survival (PFS)
Time frame: From time of informed consent and up to 3 years after final patient is enrolled
Overall survival (OS)
Time frame: From time of informed consent and up to 3 years after final patient is enrolled
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 28 Feb 2020.
- Derived from this study: PubMed 38683495Maris M, Salles G, Kim WS, Kim TM, Lyons RM, Arellano M, Karmali R, Schiller G, Cull E, Abboud CN, Batlevi C, Kagiampakis I, Rebelatto MC, Lee Y, Kirby LC, Wang F, Bothos J, Townsley DM, Fathi AT, Ribrag V. ASCT2-Targeting Antibody-Drug Conjugate MEDI7247 in Adult Patients with Relapsed/Refractory Hematological Malignancies: A First-in-Human, Phase 1 Study. Target Oncol. 2024 May;19(3):321-332. doi: 10.1007/s11523-024-01054-z. Epub 2024 Apr 29.
- Individual participant dataSharing planned: Undecided
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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.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI7247 in people with Acute Myeloid Leukemia and Multiple Myeloma, run by MedImmune LLC at 14 sites in 3 countries.
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 10 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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, France, South Korea. 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?
Occurrence of adverse events (AEs) (time frame: From time of informed consent through 90 days post end of treatment). The study lists 7 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 NCT03106428, 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 28 Feb 2020.