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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:1/31/2018
Start Date:March 2, 2015
End Date:January 9, 2018

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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

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.

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.
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