A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors

NCT02318394 | Completed Phase 1

• 1 other identifier: D6060C00001
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 12

Brief Summary

To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced solid tumors

Conditions

Advanced Solid Tumors

Keywords

advanced solid tumors; immunotherapy; OX40; immuno-oncology

Outcome Measures

Primary Outcomes (1)

• 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.

  From time of informed consent through 12 weeks after last dose of MEDI0562

Secondary Outcomes (8)

• Objective response rate (ORR)

  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

  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)

  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

  From time of informed consent through 12 weeks after last dose of investigational product

• Disease control rate (DCR)

  Estimated to be from time of informed consent up to 5 years

Study Arms (1)

Monotherapy Arm

EXPERIMENTAL

MEDI0562 monotherapy

Biological: MEDI0562

Interventions

MEDI0562 BIOLOGICAL

Subjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops.

Monotherapy Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (12)

Research Site

La Jolla, California, 92093, United States

Location

Research Site

Ann Arbor, Michigan, 48109, United States

Location

Research Site

Detroit, Michigan, 48201, United States

Location

Research Site

Minneapolis, Minnesota, 55404, United States

Location

Research Site

New York, New York, 10032, United States

Location

Research Site

The Bronx, New York, 10461, United States

Location

Research Site

Huntersville, North Carolina, 28078, United States

Location

Research Site

Portland, Oregon, 97213, United States

Location

Research Site

Pittsburgh, Pennsylvania, 15232, United States

Location

Research Site

Dallas, Texas, 75201, United States

Location

Research Site

Houston, Texas, 77005, United States

Location

Research Site

Seoul, 03080, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32816951 DERIVED

Study Officials

• Medimmune LLC

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 17, 2014
• Study Start: March 2, 2015
• Primary Completion: January 9, 2018
• Study Completion: January 9, 2018
• Last Updated: January 29, 2018

Record last verified: 2018-01

Locations

US (11); KR (1)