A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Biological: MEDI0562
- Registration Number
- NCT02318394
- Lead Sponsor
- MedImmune LLC
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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).
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Prior treatment with TNFRSF agonists.
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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.
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History of severe allergic reactions to any unknown allergens or any components of the study drug formulations.
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Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI0562.
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Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
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Unresolved toxicities from prior anticancer therapy.
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Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Monotherapy Arm MEDI0562 MEDI0562 monotherapy
- Primary Outcome Measures
Name Time Method Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) 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.
- Secondary Outcome Measures
Name Time Method Duration of response (DoR) Estimated to be from time of informed consent up to 5 years 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.
Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs) From first dose of MEDI0562 through to 30 days after last dose of investigational product The immunogenicity of MEDI0562 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Disease control rate (DCR) Estimated to be from time of informed consent up to 5 years 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)
Objective response rate (ORR) Estimated to be from time of informed consent up to 5 years The ORR is defined as the proportion of subjects with confirmed immune related (ir)CR or confirmed irPR
Maximum observed concentration (Cmax), area under the curve (AUC), clearance (CL) and terminal half-life of MEDI0562 From first dose of MEDI0562 through to 30 days after last dose of investigational product The endpoints for assessment of PK of MEDI0562 include MEDI0562 concentrations in serum at different timepoints after MEDI0562 administration.
Progression-free survival (PFS) Estimated to be from time of informed consent up to 5 years 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.
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 From time of informed consent through 12 weeks after last dose of investigational product 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
Overall survival (OS) Estimated to be from time of informed consent up to 5 years Overall survival will be determined as the time from the start of treatment with MEDI0562 until death due to any cause.
Trial Locations
- Locations (1)
Research Site
🇰🇷Seoul, Korea, Republic of