Locally Advanced Malignant NeoplasmPhase 1NCT03295942
A Study of OMP-336B11 in Subjects With Locally Advanced or Metastatic Tumors
A Phase 1 study testing OMP-336B11 in people with Locally Advanced Malignant Neoplasm and Metastatic Cancer, run by OncoMed Pharmaceuticals, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Locally Advanced Malignant Neoplasm, Metastatic Cancer
- What is being tested?
- OMP-336B11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2017to 4 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
About this study
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
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.
Read the 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.
- Being tested
- OMP-336B11
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMP-336B11Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| OMP-336B11 | Experimental | Intravenous (in the vein) infusions of OMP-336B11 Receives: Drug: OMP-336B11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29)
Secondary outcomes (6)
Pharmacokinetic Outcome Measures (CL)
Clearance (CL) will be evaluated
Measured: Screening through 12 weeks post treatment termination
Pharmacokinetic Outcome Measures (Vd)
Volume of distribution (Vd) will be evaluated
Measured: Screening through 12 weeks post treatment termination
Pharmacokinetic Outcome Measures (T1/2)
The half life (T1/2) of OMP-336B11 will be assessed
Measured: Screening through 12 weeks post treatment termination
Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies)
Percentage of patients with anti-336B11 antibodies assessed
Measured: up to approximately 2 years
Objective Response
Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: up to approximately 2 years
Progression-Free Survival
Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start12 Sep 2017
- Primary completion4 Jul 2019
- Study completion4 Jul 2019
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- OMP-336B11
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyriakos P Papadopoulos, MD, Principal investigator, South Texas Accelerated Research Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295942
- Sponsor's protocol ID
- 336B11-001
- Status last verified
- Aug 2020
- First submitted
- 13 Sep 2017
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03295942
- Acronym / sponsor ID
- 336B11-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 24 participants (actual)
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- OMP-336B11
| Arm | Type | Receives |
|---|---|---|
| OMP-336B11 | Experimental | Drug: OMP-336B11Intravenous (in the vein) infusions of OMP-336B11 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMP-336B11OMP-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. | Drug | OMP-336B11 |
Primary outcome
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)
6 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
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyriakos P Papadopoulos, MD principal investigator
South Texas Accelerated Research Therapeutics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OMP-336B11 in people with Locally Advanced Malignant Neoplasm and Metastatic Cancer, run by OncoMed Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.