A Study in Adult Subjects With Select Advanced Solid Tumors

MedImmune LLC40 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors

Interventions

MEDI1873BIOLOGICAL

Subjects will receive MEDI1873 by intravenous administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Research Site

Phoenix, Arizona, United States

Research Site

Scottsdale, Arizona, United States

Research Site

Los Angeles, California, United States

Research Site

Tampa, Florida, United States

Outcomes

Primary Outcomes

Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

The maximum tolerated dose (MTD)/highest protocol-defined dose level in the absence of establishing an MTD will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, DLTs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.

Time frame: From time of informed consent through 12 months after last dose of MEDI1873

Secondary Outcomes

Objective response rate (ORR)

The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1

Time frame: Estimated to be from time of informed consent up to 4.5 years

Disease control rate (DCR)

The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1

Time frame: Estimated to be from time of informed consent up to 4.5 years

Duration of response (DoR)

Duration of response will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

Time frame: Estimated to be from time of informed consent up to 4.5 years

Progression-free survival (PFS)

Progression-free survival will be measured from the start of treatment with MEDI1873 until the first documentation of disease progression or death due to any cause, whichever occurs first.

Time frame: Estimated to be from time of informed consent up to 4.5 years

Data from ClinicalTrials.gov

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