---
title: A Study of OMP-336B11 in Subjects With Locally Advanced or Metastatic Tumors
nct_id: NCT03295942
overall_status: TERMINATED
phase: PHASE1
sponsor: OncoMed Pharmaceuticals, Inc.
study_type: INTERVENTIONAL
primary_condition: Locally Advanced Malignant Neoplasm
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03295942.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03295942"
ct_last_update_post_date: 2020-08-11
last_seen_at: "2026-05-12T06:17:36.814Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT03295942](https://clinicaltrials.gov/study/NCT03295942)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Sponsor decision
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** OncoMed Pharmaceuticals, Inc.
- **Conditions:** Locally Advanced Malignant Neoplasm, Metastatic Cancer
- **Start Date:** 2017-09-12
- **Completion Date:** 2019-07-04
- **CT.gov Last Update:** 2020-08-11

## 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

- **Minimum age:** 21 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **OMP-336B11** (EXPERIMENTAL) — Intravenous (in the vein) infusions of OMP-336B11

## Interventions

- **OMP-336B11** (DRUG) — 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.

## Primary Outcomes

- **The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11** _(time frame: Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29))_ — Incidence of dose limiting toxicities (DLTs)

## Secondary Outcomes

- **Pharmacokinetic Outcome Measures (CL)** _(time frame: Screening through 12 weeks post treatment termination)_
- **Pharmacokinetic Outcome Measures (Vd)** _(time frame: Screening through 12 weeks post treatment termination)_
- **Pharmacokinetic Outcome Measures (T1/2)** _(time frame: Screening through 12 weeks post treatment termination)_
- **Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies)** _(time frame: up to approximately 2 years)_
- **Objective Response** _(time frame: up to approximately 2 years)_
- **Progression-Free Survival** _(time frame: up to approximately 2 years)_

## Locations (1)

- South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.south texas accelerated research therapeutics, llc|san antonio|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03295942.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03295942*  
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