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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Biological: MEDI0562

Study type: Interventional

Funder types: Industry

Identifiers

NCT02318394

D6060C00001

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Monotherapy Arm

Experimental group

Description:

MEDI0562 monotherapy

Treatment:

Biological: MEDI0562