Advanced Solid TumorsPhase 1NCT02583165
A Study in Adult Subjects With Select Advanced Solid Tumors
A Phase 1 study testing MEDI1873 in people with Advanced Solid Tumors, run by MedImmune LLC at 10 sites in United States.
Trial summary
To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- MEDI1873
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesUnited States
- Study dates
- 9 Nov 2015to 19 Dec 2018
- 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
- All subjects must consent to provide archived tumor specimen
- Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease.
- At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic
- Willingness to provide pretreatment and on-treatment biopsies.
- Adequate organ function
- Females of childbearing potential and nonsterilized males who are sexually active must use effective methods of contraception
Who cannot join
- Known allergic reaction to any component of MEDI1873
- Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
- Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873
- Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
- Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational product
- Unresolved toxicities from prior anticancer therapy
- Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Research Site
Houston, Texas, 77521
Research Site
Los Angeles, California, 90025
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10032
Research Site
Oklahoma City, Oklahoma, 73117
Research Site
Philadelphia, Pennsylvania, 19111
Research Site
Phoenix, Arizona, 85054
Research Site
Rochester, Minnesota, 55905
Research Site
Scottsdale, Arizona, 85258
Research Site
Tampa, Florida, 33612
About this study
Official title: A Phase 1 Study of MEDI1873 (GITR Agonist) in Adult Subjects With Select Advanced Solid Tumors
To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.
Read the detailed description
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm dose-escalation study of MEDI1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies
- Conditions
- Advanced Solid Tumors
- Being tested
- MEDI1873
- Keywords
- advanced solid tumors, immunotherapy, immuno-oncology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI1873Biological
Subjects will receive MEDI1873 by intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy arm | Experimental | MEDI1873 Receives: Biological: MEDI1873 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
The maximum tolerated dose (MTD)/highest protocol-defined dose level in the absence of establishing an MTD will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, DLTs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
Measured: From time of informed consent through 12 months after last dose of MEDI1873
Secondary outcomes (12)
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Measured: Estimated to be from time of informed consent up to 4.5 years
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1
Measured: Estimated to be from time of informed consent up to 4.5 years
Duration of response (DoR)
Duration of response will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: Estimated to be from time of informed consent up to 4.5 years
Progression-free survival (PFS)
Progression-free survival will be measured from the start of treatment with MEDI1873 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: Estimated to be from time of informed consent up to 4.5 years
Overall survival (OS)
Overall survival will be determined as the time from the start of treatment with MEDI1873 until death due to any cause.
Measured: Estimated to be from time of informed consent up to 4.5 years
Maximum observed concentration (Cmax) of MEDI1873
The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration
Measured: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of MEDI1873 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
Measured: From first dose of MEDI1873 through to 12 months after last dose of MEDI1873
PD biomarkers including changes from baseline levels in various lymphocyte populations
PD biomarkers including changes from baseline levels in various lymphocyte populations
Measured: From time of informed consent through to disease progression, assessed up to 4.5 years
Area under the curve (AUC) of MEDI1873
The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration
Measured: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Clearance (CL) of MEDI1873
The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration
Measured: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Terminal half-life of MEDI1873
The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration
Measured: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Percentage of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of MEDI1873 will be assessed by summarizing the percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Measured: From first dose of MEDI1873 through to 12 months after last dose of MEDI1873
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start9 Nov 2015
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
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
- 40 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
- NCT02583165
- Sponsor's protocol ID
- D6150C00001
- Status last verified
- Jan 2019
- First submitted
- 19 Oct 2015
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of MEDI1873 (GITR Agonist) in Adult Subjects With Select Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02583165
- Acronym / sponsor ID
- D6150C00001
- Conditions
- Advanced Solid Tumors
- Keywords
- advanced solid tumors, immunotherapy, immuno-oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 22 Oct 2015 (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.
To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.
Detailed description
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm dose-escalation study of MEDI1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monotherapy arm | Experimental | Biological: MEDI1873MEDI1873 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All subjects must consent to provide archived tumor specimen
- Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease.
- At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic
- Willingness to provide pretreatment and on-treatment biopsies.
- Adequate organ function
Key exclusion criteria (7 listed)
- Known allergic reaction to any component of MEDI1873
- Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
- Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873
- Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
- Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational product
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 |
|---|---|---|
| MEDI1873Subjects will receive MEDI1873 by intravenous administration | Biological | Monotherapy arm |
Primary outcome
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Time frame: From time of informed consent through 12 months after last dose of MEDI1873
The maximum tolerated dose (MTD)/highest protocol-defined dose level in the absence of establishing an MTD will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, DLTs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
12 secondary outcomes
Objective response rate (ORR)
Time frame: Estimated to be from time of informed consent up to 4.5 years
Disease control rate (DCR)
Time frame: Estimated to be from time of informed consent up to 4.5 years
Duration of response (DoR)
Time frame: Estimated to be from time of informed consent up to 4.5 years
Progression-free survival (PFS)
Time frame: Estimated to be from time of informed consent up to 4.5 years
Overall survival (OS)
Time frame: Estimated to be from time of informed consent up to 4.5 years
Maximum observed concentration (Cmax) of MEDI1873
Time frame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of MEDI1873 through to 12 months after last dose of MEDI1873
PD biomarkers including changes from baseline levels in various lymphocyte populations
Time frame: From time of informed consent through to disease progression, assessed up to 4.5 years
Area under the curve (AUC) of MEDI1873
Time frame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Clearance (CL) of MEDI1873
Time frame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Terminal half-life of MEDI1873
Time frame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of MEDI1873 through to 12 months after last dose of MEDI1873
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 Jan 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.
Medimmune LLC study director
MedImmune LLC
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 MEDI1873 in people with Advanced Solid Tumors, run by MedImmune LLC 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 6 inclusion and 7 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 8 Jan 2019. 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?
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) (time frame: From time of informed consent through 12 months after last dose of MEDI1873). 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 Jan 2019.