A Study in Adult Subjects With Select Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1 Study of MEDI1873 (GITR Agonist) in Adult Subjects With Select Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583165
• Other study ID #: D6150C00001
• Status: Completed
• Phase: Phase 1
• Start date: November 9, 2015
• Est. completion date: December 19, 2018

Study information

• Verified date: January 2019
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 19, 2018
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Biological:
• MEDI1873
Subjects will receive MEDI1873 by intravenous administration

Locations

Country	Name	City	State
United States	Research Site	Houston	Texas
United States	Research Site	Los Angeles	California
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Rochester	Minnesota
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Estimated to be from time of informed consent up to 4.5 years
Secondary	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	Estimated to be from time of informed consent up to 4.5 years
Secondary	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.	Estimated to be from time of informed consent up to 4.5 years
Secondary	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.	Estimated to be from time of informed consent up to 4.5 years
Secondary	Overall survival (OS)	Overall survival will be determined as the time from the start of treatment with MEDI1873 until death due to any cause.	Estimated to be from time of informed consent up to 4.5 years
Secondary	Maximum observed concentration (Cmax) of MEDI1873	The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration	From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Secondary	Number of subjects who develop detectable anti-drug antibodies (ADAs)	The immunogenicity of MEDI1873 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)	From first dose of MEDI1873 through to 12 months after last dose of MEDI1873
Secondary	PD biomarkers including changes from baseline levels in various lymphocyte populations	PD biomarkers including changes from baseline levels in various lymphocyte populations	From time of informed consent through to disease progression, assessed up to 4.5 years
Secondary	Area under the curve (AUC) of MEDI1873	The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration	From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Secondary	Clearance (CL) of MEDI1873	The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration	From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Secondary	Terminal half-life of MEDI1873	The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration	From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Secondary	Percentage of subjects who develop detectable anti-drug antibodies (ADAs)	The immunogenicity of MEDI1873 will be assessed by summarizing the percentage of subjects who develop detectable anti-drug antibodies (ADAs)	From first dose of MEDI1873 through to 12 months after last dose of MEDI1873