Clinical trial NCT02318394: A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: advanced solid tumors; immunotherapy; OX40; immuno-oncology
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2014-12-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
timeFrame: From time of informed consent through 12 weeks after last dose of MEDI0562
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Estimated to be from time of informed consent up to 5 years
measure: Maximum observed concentration (Cmax), area under the curve (AUC), clearance (CL) and terminal half-life of MEDI0562
timeFrame: From first dose of MEDI0562 through to 30 days after last dose of investigational product
measure: Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
timeFrame: From first dose of MEDI0562 through to 30 days after last dose of investigational product
measure: 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
timeFrame: From time of informed consent through 12 weeks after last dose of investigational product
measure: Disease control rate (DCR)
timeFrame: Estimated to be from time of informed consent up to 5 years
measure: Duration of response (DoR)
timeFrame: Estimated to be from time of informed consent up to 5 years
measure: Progression-free survival (PFS)
timeFrame: Estimated to be from time of informed consent up to 5 years
measure: Overall survival (OS)
timeFrame: Estimated to be from time of informed consent up to 5 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Research Site
state: California
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Bronx
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Huntersville
country: United States
facility: Research Site
state: North Carolina
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: MedImmune LLC
name: Medimmune LLC
role: STUDY_DIRECTOR
References:
citation: 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.