Advanced Solid MalignanciesPhase 1NCT03736473
A Phase I Study of MEDI9447 (Oleclumab) in Japanese Patients
A Phase 1 study testing MEDI9447 (oleclumab) in people with Advanced Solid Malignancies, run by AstraZeneca at 1 site in Japan.
Trial summary
This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MEDI9447 in Japanese patients with advanced solid malignancies.This study consists of 2 cohorts. Cohort 1 (dose level 1) and Cohort 2 (dose level 2). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- MEDI9447 (oleclumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- 7 Nov 2018to 19 Jun 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Major Inclusion Criteria:
- Adult subjects; age ≥ 20 years
- Has a histologically confirmed solid malignancy that is refractory to standard therapy or for which no standard of care regimen currently exists
- Subjects must have at least 1 lesion that is measureable using RECIST v1.1
- All subjects must consent to provide archived tumor specimens for biomarker studies
- ECOG Performance Status of 0 or 1
- Life expectancy ≥12 weeks
- Adequate organ function
- Body weight ≥ 35 kg
Major Exclusion Criteria:
- Patients must have completed any previous cancer-related treatments before enrollment.
- Prior treatment with CD73 antagonist, tumor necrosis factor receptor superfamily agonists
- All CTLA-4, PD-1, or PD-L1 antagonists related-AEs must have resolved to ≤ NCI CTCAE v4.03 Grade 1 or baseline prior to screening and not worsened before the first dose of study drug
- Must not have required the use of additional immunosuppression other than corticosteroids for the management of an CTLA-4, PD-1, or PD-L1 related AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day
- Known allergy or hypersensitivity to the study drug, its compounds, or agents similar biologic composition
- History of more than one event of IRR requiring permanent discontinuation of IV drug treatment
- History of severe drug allergies or anaphylaxis to 2 or more food products or medicine
- Cardiac or peripheral vascular disease
- NCI CTCAE v4.03 Grade 3 or greater edema
- Uncontrolled massive ascites or pleural effusion
- History of NCI CTCAE v4.03 Grade 3 or greater thromboembolic events within 3 months prior to the first dose of study drug or thromboembolic event of any grade with ongoing symptoms
- Active tuberculosis
- Patients with history of, or current ILD
- Active or prior documented autoimmune within the past 3 years prior to the start of treatment
- Untreated or unstable CNS metastatic disease, leptomeningeal disease, or cord compression
- Concurrent enrollment in another clinical study
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
- Toxicities from prior anticancer therapy that have not resolved to ≤ NCI CTCAE v4.03 Grade 1 or baseline prior to the first dose of study drug
- History of primary immunodeficiency or solid organ transplantation
- Active hepatitis B, hepatitis C, or HIV
- Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
- Other invasive malignancy within 2 years prior to the first dose of study drug
- Uncontrolled concomitant illnes
- Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Involvement in the planning and/or conduct of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of MEDI9447 (Oleclumab) in Japanese Patients With Advanced Solid Malignancies
This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MEDI9447 in Japanese patients with advanced solid malignancies.This study consists of 2 cohorts. Cohort 1 (dose level 1) and Cohort 2 (dose level 2). At least 3 or up to 6 evaluable Japanese patients with advanced solid malignancies will be enrolled in each cohort.
Read the detailed description
Objectives:
Primary objective:
To assess the safety and tolerability, describe any dose-limiting toxicity (DLT) for MEDI9447
Secondary objective:
To determine the pharmacokinetics (PK) characteristics of MEDI9447 To determine the immunogenicity of MEDI9447 To evaluate candidate biomarker of MEDI9447 activity in archival tumor biopsy specimens To describe the preliminary antitumor activity of MEDI9447
Exploratory Objective:
To explore profile of biomarker status, with MEDI9447 treatment
Overall design:
This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MEDI9447 in Japanese patients with advanced solid malignancies.
This study consists of 2 cohorts. Cohort (dose level 1) and Cohort 2 (dose level 2).
At least 3 or up to 6 evaluable Japanese patients with advanced solid malignancies will be enrolled in each cohort. The total number of subjects will depend upon the available data in each cohort and Safety Review Committee (SRC)'s decision.
Study Period:
The study is expected to start in October 2018 and end in July 2019.
Number of Subjects:
Maximum 12 evaluable patients will be enrolled in this study.
Treatments and treatment duration:
Subjects will receive MEDI9447 on Day 1 and Day 15 in a 4-week cycle. Subjects participating in the study may continue to receive study treatment(s) as long as they are continuing to show clinical benefit, as judged by the Investigator, unless the subject has progressive disease (PD) with either clinical deterioration and/or no further benefit from treatment, experiences unacceptable toxicity, or should discontinue for any other reason. In such cases, the Investigator needs to consult with the sponsor and they agree to continue study treatment in advance.
Statistical methods:
The primary objective of this study is to assess the safety and tolerability profile of MEDI9447.
All safety data will be summarized using the safety analysis set (All subjects who received at least 1 dose of MEDI9447). Evaluations of safety and tolerability will include, but not be limited to, AEs, physical examinations, laboratory findings (including clinical chemistry, hematology, and urinalysis), vital signs (including blood pressure and pulse), and electrocardiograms using summary statistics.
For secondary and exploratory efficacy endpoints, all analyses will be descriptive, and no formal statistical testing will be performed. Data will be summarized and plotted appropriately according to data type.
PK concentration data for MEDI9447 will be listed for each subject and each dosing day, and summary statistics will be tabulated. Immunogenicity results will be listed by subject, and summaries of the number and percentage of subjects who develop detectable antidrug antibodies (ADAs) against MEDI9447 will be provided. The immunogenicity titre will be listed for samples confirmed positive for the presence of ADAs. Neutralizing ADAs may be reported for samples confirmed positive for the presence of ADAs.
All analyses and reporting will be conducted for each cohort.
- Conditions
- Advanced Solid Malignancies
- Being tested
- MEDI9447 (oleclumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI9447 (oleclumab)Drug
MEDI9447 administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| MEDI9447 monotherapy | Other | Dose escalation of MEDI9447 monotherapy for patients with advanced solid malignancies Receives: Drug: MEDI9447 (oleclumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
To assess the safety and tolerability, describe any dose-limiting toxicity (DLT) for MEDI9447
Measured: From the informed consent to 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start7 Nov 2018
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid MalignanciesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736473
- Sponsor's protocol ID
- D6070C00006
- Status last verified
- Jun 2019
- First submitted
- 7 Nov 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of MEDI9447 (Oleclumab) in Japanese Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT03736473
- Acronym / sponsor ID
- D6070C00006
- Conditions
- Advanced Solid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 9 Nov 2018 (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 phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MEDI9447 in Japanese patients with advanced solid malignancies.This study consists of 2 cohorts. Cohort 1 (dose level 1) and Cohort 2 (dose level 2). At least 3 or up to 6 evaluable Japanese patients with advanced solid malignancies will be enrolled in each cohort.
Detailed description
Objectives:
Primary objective:
To assess the safety and tolerability, describe any dose-limiting toxicity (DLT) for MEDI9447
Secondary objective:
To determine the pharmacokinetics (PK) characteristics of MEDI9447 To determine the immunogenicity of MEDI9447 To evaluate candidate biomarker of MEDI9447 activity in archival tumor biopsy specimens To describe the preliminary antitumor activity of MEDI9447
Exploratory Objective:
To explore profile of biomarker status, with MEDI9447 treatment
Overall design:
This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MEDI9447 in Japanese patients with advanced solid malignancies.
This study consists of 2 cohorts. Cohort (dose level 1) and Cohort 2 (dose level 2).
At least 3 or up to 6 evaluable Japanese patients with advanced solid malignancies will be enrolled in each cohort. The total number of subjects will depend upon the available data in each cohort and Safety Review Committee (SRC)'s decision.
Study Period:
The study is expected to start in October 2018 and end in July 2019.
Number of Subjects:
Maximum 12 evaluable patients will be enrolled in this study.
Treatments and treatment duration:
Subjects will receive MEDI9447 on Day 1 and Day 15 in a 4-week cycle. Subjects participating in the study may continue to receive study treatment(s) as long as they are continuing to show clinical benefit, as judged by the Investigator, unless the subject has progressive disease (PD) with either clinical deterioration and/or no further benefit from treatment, experiences unacceptable toxicity, or should discontinue for any other reason. In such cases, the Investigator needs to consult with the sponsor and they agree to continue study treatment in advance.
Statistical methods:
The primary objective of this study is to assess the safety and tolerability profile of MEDI9447.
All safety data will be summarized using the safety analysis set (All subjects who received at least 1 dose of MEDI9447). Evaluations of safety and tolerability will include, but not be limited to, AEs, physical examinations, laboratory findings (including clinical chemistry, hematology, and urinalysis), vital signs (including blood pressure and pulse), and electrocardiograms using summary statistics.
For secondary and exploratory efficacy endpoints, all analyses will be descriptive, and no formal statistical testing will be performed. Data will be summarized and plotted appropriately according to data type.
PK concentration data for MEDI9447 will be listed for each subject and each dosing day, and summary statistics will be tabulated. Immunogenicity results will be listed by subject, and summaries of the number and percentage of subjects who develop detectable antidrug antibodies (ADAs) against MEDI9447 will be provided. The immunogenicity titre will be listed for samples confirmed positive for the presence of ADAs. Neutralizing ADAs may be reported for samples confirmed positive for the presence of ADAs.
All analyses and reporting will be conducted for each cohort.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEDI9447 monotherapy | Other | Drug: MEDI9447 (oleclumab)Dose escalation of MEDI9447 monotherapy for patients with advanced solid malignancies |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MEDI9447 (oleclumab)MEDI9447 administered intravenously | Drug | MEDI9447 monotherapy |
Primary outcome
Adverse event
Time frame: From the informed consent to 90 days after the last dose
To assess the safety and tolerability, describe any dose-limiting toxicity (DLT) for MEDI9447
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 8 Jul 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI9447 (oleclumab) in people with Advanced Solid Malignancies, run by AstraZeneca at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Adverse event (time frame: From the informed consent to 90 days after the last dose). 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 8 Jul 2019.