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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT01527136

Entolimod in Treating Patients With Locally Advanced or Metastatic Solid Tumors That Cannot Be Removed By Surgery

A Phase 1 study testing entolimod, pharmacological study and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial studies the side effects and best dose of entolimod in treating patients with locally advanced or metastatic solid tumors that cannot be removed by surgery. Biological therapies, such as entolimod, may stimulate the immune system in different ways and stop tumor cells from growing. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
entolimod, pharmacological study and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Jan 2012to Oct 2014
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent granted prior to initiation of any study-specific screening procedures, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
  • Histologically or cytologically confirmed locally advanced, inoperable or metastatic solid tumor for which no acceptable therapy exists
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy greater than 3 months
  • Platelet count >= 75 x 10^9/L
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
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  • Hemoglobin (Hgb) >= 9 gm/dL
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN, regardless of the presence of liver metastases
  • Creatinine =< 2 x ULN
  • Left ventricular ejection fraction (LVEF) >=45% by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)
  • 12-Lead Electrocardiogram (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
  • QTcB interval < 470 msec at any point prior to receiving the first dose of study drug (mean of replicate values, correction per institutional standard) and no history of Torsades des Pointes or other symptomatic QTcB abnormality
  • Absence of orthostatic hypotension

Who cannot join

  • Male and female subjects of child-bearing potential who do not agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received
  • Previous anti-cancer chemotherapy, immunotherapy or investigational agents =< 3 weeks prior to the first day of study defined treatment; palliative radiation < 2 weeks; patients who receive gamma knife radiosurgery for brain metastases are eligible if procedure was performed > 2 weeks before treated is started, is clinically stable and is not receiving corticosteroid therapy; ongoing hormonal therapies (such as, luteinizing hormone-releasing hormone [LHRH] antagonists, megestrol, anti-estrogens, or aromatase inhibitors) are allowed
  • Previous treatment with a TLR5 agonist
  • Patients with a known hypersensitivity to CBLB502 or to its excipients
  • Presence of neutralizing antibodies to CBLB502
  • Patient has a history of cardiac dysfunction including any of the following:
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  • Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes; patients with persistent regional wall abnormalities on assessment of LVEF function are not eligible
  • History of documents congestive heart failure (New York Heart Association [NYHA] functional classification III-IV) within 6 months
  • Documented cardiomyopathy
  • Diagnosed or suspected congenital QT syndrome
  • Any history of second or third degree heart block (may be eligible if currently have a pacemaker)
  • Heart rate < 50 beats/minute on pre-entry electrocardiogram
  • Uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg on 3 consecutive measurements prior to study enrollment
  • Active clinically serious infections defined as >= Grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
  • Substance abuse, medical, psychological, or social conditions that may, in the opinion of the Investigator, interfere with the patient's participation in the study or evaluation of the study results
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her protocol compliance
  • Known infection with human immunodeficiency virus (HIV) or hepatitis B or hepatitis C
  • Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) =< 2 weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued
  • Women who are pregnant or breast feeding
  • Patients receiving chronic treatment with steroids or another immunosuppressive agent; Note: topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections (e.g., intra-articular) are allowed
  • Uncontrolled diabetes mellitus defined as a HgbA1c > 7%
  • Patients who have received chemotherapy or targeted anticancer therapy >= 3 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug must recover a Grade 1 toxicity before starting the trial
  • Patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetic Profile of CBLB502 in Patients With Advanced Cancers

This phase I trial studies the side effects and best dose of entolimod in treating patients with locally advanced or metastatic solid tumors that cannot be removed by surgery. Biological therapies, such as entolimod, may stimulate the immune system in different ways and stop tumor cells from growing.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety, tolerability, and maximum tolerated dose (MTD) of CBLB502 (entolimod) in patients with advanced cancers.

SECONDARY OBJECTIVES:

  1. To assess any preliminary evidence of efficacy with the CBLB502 in patients with advanced cancers.

II. To evaluate pharmacokinetic (PK)/pharmacodynamic (PD) profiles of CBLB502 in patients with advanced cancers.

III. To characterize the effect, if any, of intramuscular or subcutaneous CBLB502 on QTcB.

TERTIARY OBJECTIVES:

  1. To correlate pre-treatment tissue expression of toll-like receptor 5 (TLR5) with clinical activity (Response Evaluation Criteria In Solid Tumors [RECIST] tumor response) and PD response (as measured by cytokine levels) of CBLB502.

OUTLINE: This is a dose-escalation study.

Patients receive entolimod intramuscularly (IM) on day 1 and subcutaneously (SC) on days 4, 8, and 11. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Being tested
entolimod, pharmacological study, laboratory biomarker analysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • entolimodDrug

    Also called CBLB502, TLR5 agonist CBLB502, toll-like receptor 5 agonist CBLB502

    Given IM or SC

  • pharmacological studyOther

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01527136
Study groupRoleWhat they receive
Treatment (entolimod)ExperimentalPatients receive entolimod IM or SC on days 1, 4, 8, and 11. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: entolimod; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD of entolimod

    Evaluated using National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

    Measured: 3 weeks

  2. Safety of entolimod

    Evaluated using NCI-CTCAE Version 4.0.

    Measured: Up to 30 days post-treatment

Secondary outcomes (3)

  1. Efficacy of entolimod in patients with advanced cancers in terms of objective response rate (ORR) and RECIST response

    ORR will be calculated as the number of patients with a confirmed complete or partial response divided by the total number of patients. Tumor response will be summarized, and the 95% confidence interval for ORR (complete response [CR] + partial response [PR]) will be presented. Evaluated using the RECIST criteria.

    Measured: Up to 3 months

  2. PK profiles of entolimod in patients with advanced cancers

    Measured: Pre-dose, 2, 4, 6, 8, 24 hours, post dose for, days 1, 4, 8 and 11

  3. PD profiles of entolimod in patients with advanced cancers

    Measured: PD plasma: pre-dose, at 2, 4 and 6 hours post dose on day 1, 4, 8, 11, 15, 22, and 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01527136
Sponsor's protocol ID
I 196111
Other IDs
NCI-2011-03565, I 196111
Status last verified
Jul 2022
First submitted
20 Dec 2011
Last updated
22 Jul 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing entolimod, pharmacological study and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Roswell Park Cancer Institute 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 14 inclusion and 23 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: finished, as of the sponsor's last update on 22 Jul 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

MTD of entolimod (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01527136.

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 22 Jul 2022.

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