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

Phase 1
18 Years
90 Years
Open (Enrolling)
Relapsed or Refractory Solid Tumors

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Trial Information

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

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for the study:

1. Age >18 years

2. ECOG performance status <2 (see Appendix B)

3. 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.

4. 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.

5. 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.

6. 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.

7. Subjects must have normal organ and marrow function as defined below:

- Absolute neutrophil count >1500/mL without growth factor support in the past 7

- 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

- 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

8. 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.

9. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Subjects who meet any of the following criteria will not be eligible for participation in
the study:

1. Currently receiving any therapeutic treatment for their malignancy including other
investigational agents

2. Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors

3. 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

4. History of a Grade 4 allergic reaction attributed to humanized or human monoclonal
antibody therapy

5. 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

6. Pregnant women or nursing women

7. 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.

8. Subjects with known HIV infection

9. Known bleeding disorder or coagulopathy

10. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.

11. Hemoptysis in excess of 2.5 mL(or one-half teaspoon) within 8 weeks of first dose of
study drug.

12. 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.

13. New York Heart Association Classification II, III, or IV (see Appendix D)

14. 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.

15. 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.

16. 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

17. Subjects with diarrhea at time of enrollment or have an ongoing requirement for anti
diarrheal therapy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

June 2015

Related Keywords:

  • Relapsed or Refractory Solid Tumors
  • Phase 1
  • Dose escalation
  • relapsed or refractory
  • solid tumor
  • Neoplasms



South Texas Accelerated Research Therapeutics, Llc San Antonio, Texas  78229
University of Colorado Denver -RCI-South Tower Aurora, Colorado  80045