Advanced Solid TumorsPhase 1NCT02900157
Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
A Phase 1 study testing MEDI9090 and Durvalumab in people with Advanced Solid Tumors, run by MedImmune LLC at 8 sites in 2 countries.
Trial summary
This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- MEDI9090 and Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 9 Aug 2016to 23 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects
- 18 years and older
- Must have histologic documentation of advanced solid tumors
- Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option
Who cannot join
- Concurrent enrollment in another clinical study
- Prior participation in clinical studies that include durvalumab alone or in combination
- Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States5 sites
Research Site
Denver, Colorado, 80218
Research Site
Huntersville, North Carolina, 28078
Research Site
Los Angeles, California, 90025
Research Site
San Antonio, Texas, 78229
Research Site
Scottsdale, Arizona, 85258
Japan3 sites
Research Site
Kōtoku, 135-8550
Research Site
Sapporo, 003-0804
Research Site
Sunto-gun, 411-8777
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- MEDI9090, Durvalumab
- Keywords
- Advanced Solid Tumor, Immunotherapy, MEDI9090, MEDI4736, Durvalumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI9090Biological
MEDI9090 will be administered by IV infusion
DurvalumabBiological
Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.
| Study group | Role | What they receive |
|---|---|---|
| MEDI9090 | Experimental | Not described Receives: Biological: MEDI9090; Biological: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting infusion related reactions
Measured: First dose of study medication through 30 days after the first dose of study medication
Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090
Measured: First dose of study medication through 6 months after the last dose of study medication
Secondary outcomes (5)
Individual MEDI9090 concentrations
Measured: First dose of study medication through 3 months after the last dose of study medication
Number of subjects reporting adverse events
Measured: Screening through 3 months after last dose of study medication
Number of subjects reporting serious adverse events
Measured: Screening through 3 months after the last dose of study medication
Number of subjects with vital sign abnormalities reported as adverse events
Measured: Screening through 3 months after the last dose of study medication
Number of subjects with ECG abnormalities reported as adverse events
Measured: Screening through 3 months after the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start9 Aug 2016
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MedImmune LLC, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900157
- Sponsor's protocol ID
- D4190C00055
- Status last verified
- Jan 2021
- First submitted
- 2 Sep 2016
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02900157
- Acronym / sponsor ID
- D4190C00055
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumor, Immunotherapy, MEDI9090, MEDI4736, Durvalumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2016 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 14 Sep 2016 (estimated)
- 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 an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEDI9090 | Experimental | Biological: MEDI9090, Biological: Durvalumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects
- 18 years and older
- Must have histologic documentation of advanced solid tumors
- Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option
Key exclusion criteria (3 listed)
- Concurrent enrollment in another clinical study
- Prior participation in clinical studies that include durvalumab alone or in combination
- Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
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 |
|---|---|---|
| MEDI9090MEDI9090 will be administered by IV infusion | Biological | MEDI9090 |
| DurvalumabDurvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090. | Biological | MEDI9090 |
Primary outcome
Number of subjects reporting infusion related reactions
Time frame: First dose of study medication through 30 days after the first dose of study medication
Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090
Time frame: First dose of study medication through 6 months after the last dose of study medication
5 secondary outcomes
Individual MEDI9090 concentrations
Time frame: First dose of study medication through 3 months after the last dose of study medication
Number of subjects reporting adverse events
Time frame: Screening through 3 months after last dose of study medication
Number of subjects reporting serious adverse events
Time frame: Screening through 3 months after the last dose of study medication
Number of subjects with vital sign abnormalities reported as adverse events
Time frame: Screening through 3 months after the last dose of study medication
Number of subjects with ECG abnormalities reported as adverse events
Time frame: Screening through 3 months after the last dose of study medication
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 14 Jan 2021.
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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.
MedImmune LLC study director
MedImmune LLC
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI9090 and Durvalumab in people with Advanced Solid Tumors, run by MedImmune LLC at 8 sites in 2 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 4 inclusion and 3 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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, 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?
Number of subjects reporting infusion related reactions (time frame: First dose of study medication through 30 days after the first dose of study medication). 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 14 Jan 2021.