A Study in Adult Subjects With Select Advanced Solid Tumors

MedImmune

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Biological: MEDI1873

Study type

Interventional

Funder types

Industry

Identifiers

NCT02583165

D6150C00001

Details and patient eligibility

About

To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.

Full description

This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm dose-escalation study of MEDI1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All subjects must consent to provide archived tumor specimen
Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease.
At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic
Willingness to provide pretreatment and on-treatment biopsies.
Adequate organ function
Females of childbearing potential and nonsterilized males who are sexually active must use effective methods of contraception

Exclusion criteria

Known allergic reaction to any component of MEDI1873
Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational product
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.