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Relapsed or Refractory Solid TumorsPhase 1NCT01778439

A Dose Escalation Study of OMP-52M51 in Subjects With Solid Tumors

A Phase 1 study testing OMP-52M51 in people with Relapsed or Refractory Solid Tumors, run by OncoMed Pharmaceuticals, Inc. at 6 sites 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 is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects with relapsed or refractory solid tumors. Study includes a dose escalation phase and expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Relapsed or Refractory Solid Tumors
What is being tested?
OMP-52M51
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
6 sitesUnited States
Study dates
Feb 2013to Jul 2016
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following criteria to be eligible for the study:
  • Age >18 years
  • ECOG performance status <2 (see Appendix B)
  • Solid tumor malignancy for which there is no remaining standard therapy or either refuse or are not considered to be candidates for any remaining standard therapy.
  • Must have a tumor that is measurable or evaluable per RECIST v1.1 in the dose escalation phase. In the expansion cohort(s), subjects must have measurable disease.
  • Subjects must have Formalin-Fixed, Paraffin-Embedded (FFPE) tissue available either archived or fresh core or punch needle biopsied at study entry (two fresh cores/punches preferred whenever possible) for determination of Notch1 pathway activation status.
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  • Must have received their last chemotherapy, biologic, radiotherapy, or investigational therapy at least 4 weeks prior to enrollment; 6 weeks if the last regimen included BCNU or mitomycin C.
  • Subjects must have normal organ and marrow function as defined below:
  • Absolute neutrophil count >1500/mL without growth factor support in the past 7 days
  • Platelets >100,000/mL without transfusions in the past 7 days
  • Total bilirubin <1.5 X institutional upper limit of normal (ULN) (<2X ULN for subjects with Gilbert's syndrome)
  • AST (SGOT) and ALT (SGPT) <3 X institutional ULN (for subjects with hepatic involvement <5 X institutional ULN but cannot be associated with elevated bilirubin)
  • PT/INR and aPTT within 1.5 X institutional ULN
  • Creatinine <1.5 X institutional ULN OR
  • Creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
  • Normal Ejection Fraction (>50%) on ECHO scan or MUGA
  • Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug. Should a woman enrolled in the study or a female partner of a man enrolled in the study become pregnant or suspect she is pregnant while participating in this study or within 6 months after discontinuation of study, she should inform the Investigator immediately.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Subjects who meet any of the following criteria will not be eligible for participation in the study:
  • Currently receiving any therapeutic treatment for their malignancy including other investigational agents
  • Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
  • Uncontrolled seizure disorder, active neurologic disease, or active CNS involvement except for individuals who have previously-treated CNS metastases, are asymptomatic, and have no requirement for higher doses of corticosteroids (> prednisone 10mg orally per day) or anti-seizure medication for at least 4 weeks prior to first dose of study drug.
  • History of a Grade 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
  • Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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  • Pregnant women or nursing women
  • Ongoing malignancies or malignancies in remission <3 years other than the malignancies included in this trial. Patients with history of known squamous cell skin cancers within the past 3 years will not be included in this trial. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, and low-grade local bladder cancer.
  • Subjects with known HIV infection
  • Known bleeding disorder or coagulopathy
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.
  • Hemoptysis in excess of 2.5 mL(or one-half teaspoon) within 8 weeks of first dose of study drug.
  • Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
  • New York Heart Association Classification II, III, or IV (see Appendix D)
  • Subjects with poorly controlled blood pressure (defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) that is not responsive to medical therapy. Subjects taking antihypertensive medications must be taking ≤2 medications to obtain this level of blood pressure control.
  • NOTE: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry.
  • Subjects with ECG evidence of ischemia or ≥Grade 2 ventricular arrhythmia, subjects who have a history of acute myocardial infarction within 6 months, or subjects with unstable angina.
  • Subjects with known clinically significant gastrointestinal disease including, but not limited to:
  • inflammatory bowel disease
  • active peptic ulcer disease
  • known intraluminal metastatic lesion(s) with risk of bleeding
  • history of abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
  • Subjects with diarrhea at time of enrollment or have an ongoing requirement for anti diarrheal therapy

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Colorado Denver -RCI-South Tower

    Aurora, Colorado, 80045

  • Karmanos Cancer Institute (KCI)

    Detroit, Michigan, 48201

  • Wayne State University/Oncology Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229

  • University of California, San Francisco/Helen Diller Cancer Institute

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: A Phase 1 Dose Escalation Study of OMP-52M51 in Subjects With Solid Tumors

This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects with relapsed or refractory solid tumors. Study includes a dose escalation phase and expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy.

Being tested
OMP-52M51
Keywords
Phase 1, Dose escalation, relapsed or refractory, solid tumor
Medical subject headings
Recurrence

What participants receive

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

  • OMP-52M51Drug

Study groups in NCT01778439
Study groupRoleWhat they receive
OMP-52M51ExperimentalNot described
Receives: Drug: OMP-52M51

What is being measured

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

  1. Safety profile of OMP-52M51 in subjects with relapsed or refractory solid tumors

    Measured: Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose

Secondary outcomes (3)

  1. Pharmacokinetics (PK) of OMP-52M51 in subjects with relapsed or refractory solid tumors

    Apparent half life, AUC, clearance, volume of distribution

    Measured: PK analyses at various time points following the 1st and 2nd doses, immediately pre and post-dose for all subsequent doses at treatment term, every 4 weeks after discontinuation of study drug or 12 weeks

  2. Immunogenicity

    Measured: Assessed at baseline, prior to each dose, at treatment termination and every 4 weeks after the discontinuation of the study drug for 12 weeks.

  3. Preliminary Efficacy

    Measured: Evaluation for response will be assessed on day 70 of study and every 8 weeks (or 9 weeks for Q3W schedule) thereafter and will be based on RECIST v1.1.

Timeline

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

  1. First posted29 Jan 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionJul 2016
  4. Study completionJul 2016

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01778439
Sponsor's protocol ID
52M51-002
Status last verified
Aug 2020
First submitted
24 Jan 2013
Last updated
11 Aug 2020
Results posted
No
Data monitoring committee
No

Publications

  • Ferrarotto R, Eckhardt G, Patnaik A, LoRusso P, Faoro L, Heymach JV, Kapoun AM, Xu L, Munster P. A phase I dose-escalation and dose-expansion study of brontictuzumab in subjects with selected solid tumors. Ann Oncol. 2018 Jul 1;29(7):1561-1568. doi: 10.1093/annonc/mdy171.

    PubMed 29726923

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OMP-52M51 in people with Relapsed or Refractory Solid Tumors, run by OncoMed Pharmaceuticals, Inc. at 6 sites 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 18 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 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 6 sites 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?

Safety profile of OMP-52M51 in subjects with relapsed or refractory solid tumors (time frame: Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose). 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 NCT01778439, which also lists 1 linked publication.

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.

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