Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors

MedImmune

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Biological: Durvalumab; Biological: MEDI9090

Study type: Interventional

Funder types: Industry

Identifiers

NCT02900157

D4190C00055

Details and patient eligibility

About

This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid tumors.

Enrollment: 42 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects
• 18 years and older
• Must have histologic documentation of advanced solid tumors
• Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option

Exclusion criteria

• Concurrent enrollment in another clinical study
• Prior participation in clinical studies that include durvalumab alone or in combination
• Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

MEDI9090

Experimental group

Treatment:

Biological: MEDI9090

Biological: Durvalumab