Advanced Solid TumorsPhase 1NCT02318394
A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors
A Phase 1 study testing MEDI0562 in people with Advanced Solid Tumors, run by MedImmune LLC at 12 sites in 2 countries.
Trial summary
To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected 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?
- MEDI0562
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 2 Mar 2015to 9 Jan 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. Subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies.
- Subjects must have at least 1 measurable lesion.
- Consent to provide archived tumor specimens
- Willingness to undergo pre-treatment and on-treatment biopsy.
- Adequate organ function.
- Use of highly effective contraception (females) or male condom plus spermicide (males).
Who cannot join
- Prior treatment with TNFRSF agonists.
- Subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll.
- o Must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event.
- History of severe allergic reactions to any unknown allergens or any components of the study drug formulations.
- Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI0562.
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- 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
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Dallas, Texas, 75201
Research Site
Detroit, Michigan, 48201
Research Site
Houston, Texas, 77005
Research Site
Huntersville, North Carolina, 28078
Research Site
La Jolla, California, 92093
Research Site
Minneapolis, Minnesota, 55404
Research Site
New York, New York, 10032
Research Site
Pittsburgh, Pennsylvania, 15232
Research Site
Portland, Oregon, 97213
Research Site
The Bronx, New York, 10461
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors
To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced solid tumors
Read the detailed description
This is a first-time-in-human (FTiH) Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of MEDI0562 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with selected advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- MEDI0562
- Keywords
- advanced solid tumors; immunotherapy; OX40; immuno-oncology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI0562Biological
Subjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Arm | Experimental | MEDI0562 monotherapy Receives: Biological: MEDI0562 |
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/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
Measured: From time of informed consent through 12 weeks after last dose of MEDI0562
Secondary outcomes (8)
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed immune related (ir)CR or confirmed irPR
Measured: Estimated to be from time of informed consent up to 5 years
Maximum observed concentration (Cmax), area under the curve (AUC), clearance (CL) and terminal half-life of MEDI0562
The endpoints for assessment of PK of MEDI0562 include MEDI0562 concentrations in serum at different timepoints after MEDI0562 administration.
Measured: From first dose of MEDI0562 through to 30 days after last dose of investigational product
Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of MEDI0562 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Measured: From first dose of MEDI0562 through to 30 days after last dose of investigational product
Induction of proliferation markers on various lymphocyte subsets, immunohistochemistry of tumor biopsies and assessment of programmed death ligand 1 (PD-L1) and tumor-infiltrating lymphocyte phenotypic markers
The endpoints for assessment of pharmacodynamic activity include induction of proliferation markers in various lymphoctye subsets, immunohistochemistry of tumor biopsies and assessment of programmed death ligand 1 (PD-L1) and tumor-infiltrating lymphocyte phenotypic markers
Measured: From time of informed consent through 12 weeks after last dose of investigational product
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with irCR, irPR, or irSD (subjects achieving irSD will be included in the DCR if they maintain irSD for ≥8 weeks)
Measured: Estimated to be from time of informed consent up to 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 5 years
Progression-free survival (PFS)
Progression-free survival will be measured from the start of treatment with MEDI0562 until the first documentation of confirmed immune-related disease progression or death due to any cause, whichever occurs first.
Measured: Estimated to be from time of informed consent up to 5 years
Overall survival (OS)
Overall survival will be determined as the time from the start of treatment with MEDI0562 until death due to any cause.
Measured: Estimated to be from time of informed consent up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study start2 Mar 2015
- Primary completion9 Jan 2018
- Study completion9 Jan 2018
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 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
- 56 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
- NCT02318394
- Sponsor's protocol ID
- D6060C00001
- Status last verified
- Jan 2018
- First submitted
- 3 Dec 2014
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Glisson BS, Leidner RS, Ferris RL, Powderly J, Rizvi NA, Keam B, Schneider R, Goel S, Ohr JP, Burton J, Zheng Y, Eck S, Gribbin M, Streicher K, Townsley DM, Patel SP. Safety and Clinical Activity of MEDI0562, a Humanized OX40 Agonist Monoclonal Antibody, in Adult Patients with Advanced Solid Tumors. Clin Cancer Res. 2020 Oct 15;26(20):5358-5367. doi: 10.1158/1078-0432.CCR-19-3070. Epub 2020 Aug 14.
PubMed 32816951
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02318394
- Acronym / sponsor ID
- D6060C00001
- Conditions
- Advanced Solid Tumors
- Keywords
- advanced solid tumors; immunotherapy; OX40; immuno-oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 17 Dec 2014 (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 MEDI0562 in adult subjects with selected advanced solid tumors
Detailed description
This is a first-time-in-human (FTiH) Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of MEDI0562 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with selected 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 |
|---|---|---|
| Monotherapy Arm | Experimental | Biological: MEDI0562MEDI0562 monotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. Subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies.
- Subjects must have at least 1 measurable lesion.
- Consent to provide archived tumor specimens
- Willingness to undergo pre-treatment and on-treatment biopsy.
- Adequate organ function.
Key exclusion criteria (8 listed)
- Prior treatment with TNFRSF agonists.
- Subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll.
- o Must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event.
- History of severe allergic reactions to any unknown allergens or any components of the study drug formulations.
- Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI0562.
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 |
|---|---|---|
| MEDI0562Subjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops. | 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 weeks after last dose of MEDI0562
The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
8 secondary outcomes
Objective response rate (ORR)
Time frame: Estimated to be from time of informed consent up to 5 years
Maximum observed concentration (Cmax), area under the curve (AUC), clearance (CL) and terminal half-life of MEDI0562
Time frame: From first dose of MEDI0562 through to 30 days after last dose of investigational product
Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of MEDI0562 through to 30 days after last dose of investigational product
Induction of proliferation markers on various lymphocyte subsets, immunohistochemistry of tumor biopsies and assessment of programmed death ligand 1 (PD-L1) and tumor-infiltrating lymphocyte phenotypic markers
Time frame: From time of informed consent through 12 weeks after last dose of investigational product
Disease control rate (DCR)
Time frame: Estimated to be from time of informed consent up to 5 years
Duration of response (DoR)
Time frame: Estimated to be from time of informed consent up to 5 years
Progression-free survival (PFS)
Time frame: Estimated to be from time of informed consent up to 5 years
Overall survival (OS)
Time frame: Estimated to be from time of informed consent up to 5 years
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 29 Jan 2018.
- Derived from this study: PubMed 32816951Glisson BS, Leidner RS, Ferris RL, Powderly J, Rizvi NA, Keam B, Schneider R, Goel S, Ohr JP, Burton J, Zheng Y, Eck S, Gribbin M, Streicher K, Townsley DM, Patel SP. Safety and Clinical Activity of MEDI0562, a Humanized OX40 Agonist Monoclonal Antibody, in Adult Patients with Advanced Solid Tumors. Clin Cancer Res. 2020 Oct 15;26(20):5358-5367. doi: 10.1158/1078-0432.CCR-19-3070. Epub 2020 Aug 14.
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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
12 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 MEDI0562 in people with Advanced Solid Tumors, run by MedImmune LLC at 12 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 6 inclusion and 8 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, 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?
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 weeks after last dose of MEDI0562). 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 NCT02318394, 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 29 Jan 2018.