NCT02583165

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2015

Typical duration for phase_1

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

November 9, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2018

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

3.1 years

First QC Date

October 19, 2015

Last Update Submit

January 7, 2019

Conditions

Advanced Solid Tumors

Keywords

advanced solid tumorsimmunotherapyimmuno-oncology

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (12)

  • Objective response rate (ORR)

    Estimated to be from time of informed consent up to 4.5 years

  • Disease control rate (DCR)

    Estimated to be from time of informed consent up to 4.5 years

  • Duration of response (DoR)

    Estimated to be from time of informed consent up to 4.5 years

  • Progression-free survival (PFS)

    Estimated to be from time of informed consent up to 4.5 years

  • Overall survival (OS)

    Estimated to be from time of informed consent up to 4.5 years

  • +7 more secondary outcomes

Study Arms (1)

Monotherapy arm

EXPERIMENTAL

MEDI1873

Biological: MEDI1873

Interventions

MEDI1873BIOLOGICAL

Subjects will receive MEDI1873 by intravenous administration

Monotherapy arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Phoenix, Arizona, 85054, United States

Location

Research Site

Scottsdale, Arizona, 85258, United States

Location

Research Site

Los Angeles, California, 90025, United States

Location

Research Site

Tampa, Florida, 33612, United States

Location

Research Site

Rochester, Minnesota, 55905, United States

Location

Research Site

New York, New York, 10032, United States

Location

Research Site

Oklahoma City, Oklahoma, 73117, United States

Location

Research Site

Philadelphia, Pennsylvania, 19111, United States

Location

Research Site

Nashville, Tennessee, 37203, United States

Location

Research Site

Houston, Texas, 77521, United States

Location

Study Officials

  • Medimmune LLC

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 22, 2015

Study Start

November 9, 2015

Primary Completion

December 19, 2018

Study Completion

December 19, 2018

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

US(10)