Clinical trial NCT02583165: A Study in Adult Subjects With Select Advanced Solid Tumors
Official title: A Phase 1 Study of MEDI1873 (GITR Agonist) in Adult Subjects With Select Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: advanced solid tumors
immunotherapy
immuno-oncology
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2015-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
timeFrame: From time of informed consent through 12 months after last dose of MEDI1873
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Estimated to be from time of informed consent up to 4.5 years
measure: Disease control rate (DCR)
timeFrame: Estimated to be from time of informed consent up to 4.5 years
measure: Duration of response (DoR)
timeFrame: Estimated to be from time of informed consent up to 4.5 years
measure: Progression-free survival (PFS)
timeFrame: Estimated to be from time of informed consent up to 4.5 years
measure: Overall survival (OS)
timeFrame: Estimated to be from time of informed consent up to 4.5 years
measure: Maximum observed concentration (Cmax) of MEDI1873
timeFrame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
measure: Number of subjects who develop detectable anti-drug antibodies (ADAs)
timeFrame: From first dose of MEDI1873 through to 12 months after last dose of MEDI1873
measure: PD biomarkers including changes from baseline levels in various lymphocyte populations
timeFrame: From time of informed consent through to disease progression, assessed up to 4.5 years
measure: Area under the curve (AUC) of MEDI1873
timeFrame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
measure: Clearance (CL) of MEDI1873
timeFrame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
measure: Terminal half-life of MEDI1873
timeFrame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
measure: Percentage of subjects who develop detectable anti-drug antibodies (ADAs)
timeFrame: From first dose of MEDI1873 through to 12 months after last dose of MEDI1873
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: New York
country: United States
facility: Research Site
state: New York
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: MedImmune LLC
name: Medimmune LLC
role: STUDY_DIRECTOR
References: