Clinical trial NCT03295942: A Study of OMP-336B11 in Subjects With Locally Advanced or Metastatic Tumors
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Locally Advanced Malignant Neoplasm
Metastatic Cancer
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
First posted: 2017-09-28
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: OMP-336B11
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11
timeFrame: Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29)
Secondary outcomes:
measure: Pharmacokinetic Outcome Measures (CL)
timeFrame: Screening through 12 weeks post treatment termination
measure: Pharmacokinetic Outcome Measures (Vd)
timeFrame: Screening through 12 weeks post treatment termination
measure: Pharmacokinetic Outcome Measures (T1/2)
timeFrame: Screening through 12 weeks post treatment termination
measure: Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies)
timeFrame: up to approximately 2 years
measure: Objective Response
timeFrame: up to approximately 2 years
measure: Progression-Free Survival
timeFrame: up to approximately 2 years
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC
state: Texas
Study officials:
affiliation: South Texas Accelerated Research Therapeutics, LLC
name: Kyriakos P Papadopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: