A Study of OMP-336B11 in Subjects With Locally Advanced or Metastatic Tumors

Metastatic Cancer Clinical Trial

Official title:

A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03295942
• Other study ID #: 336B11-001
• Status: Terminated
• Phase: Phase 1
• Start date: September 12, 2017
• Est. completion date: July 4, 2019

Study information

• Verified date: August 2020
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and efficacy of OMP-336B11. OMP-336B11 is an engineered human protein that was designed to bind to the GITR receptor on T cells and activate the immune system to recognize and eliminate cancer cells.

Description:

This is an open-label, Phase 1a dose escalation study of OMP-336B11 administered as a single agent to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with locally advanced or metastatic tumors. This study consists of a screening period, a treatment period, and a post-treatment follow-up period in which patients will be followed for survival for up to approximately 2 years. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: July 4, 2019
• Est. primary completion date: July 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Locally advanced or metastatic solid tumors that have exhausted standard of care therapy

• Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1

• Age >21 years

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate organ and marrow function

• For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Receiving any other investigational agents or any other anti-cancer therapy

• Active autoimmune disease or a history of severe autoimmune disease or syndrome

• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

• Pregnancy, lactating or breastfeeding women

• History of primary CNS malignancy, or leptomeningeal disease or CNS metastases

• Significant uncontrolled intercurrent illness that will limit the patient's ability to participate in the study

• Inability to comply with study and follow up procedures

Related Conditions & MeSH terms

• Locally Advanced Malignant Neoplasm
• Metastatic Cancer
• Neoplasms

Intervention

Drug:
• OMP-336B11
OMP-336B11 is an engineered human protein that was designed to bind to the GITR receptor on T cells and activate the immune system to recognize and eliminate cancer cells.

Locations

Country	Name	City	State
United States	South Texas Accelerated Research Therapeutics, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
OncoMed Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11	Incidence of dose limiting toxicities (DLTs)	Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29)
Secondary	Pharmacokinetic Outcome Measures (CL)	Clearance (CL) will be evaluated	Screening through 12 weeks post treatment termination
Secondary	Pharmacokinetic Outcome Measures (Vd)	Volume of distribution (Vd) will be evaluated	Screening through 12 weeks post treatment termination
Secondary	Pharmacokinetic Outcome Measures (T1/2)	The half life (T1/2) of OMP-336B11 will be assessed	Screening through 12 weeks post treatment termination
Secondary	Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies)	Percentage of patients with anti-336B11 antibodies assessed	up to approximately 2 years
Secondary	Objective Response	Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	up to approximately 2 years
Secondary	Progression-Free Survival	Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	up to approximately 2 years