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BRIEF TITLE: CRESTONE: Seribantumab in Adult Patients With Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors

CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients With Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors


  • Org Study ID: ELVCAP-001-01
  • Secondary ID:
  • NCT ID: NCT04383210
  • NCT Alias:
  • Sponsor: Elevation Oncology - Industry
  • Source: Elevation Oncology

Brief Summary

This study is an open-label, international, multi-center, Phase 2 study in adult patients with recurrent, locally-advanced or metastatic solid tumors, which harbor the NRG1 gene fusion.

Overal Status Start Date Phase Study Type
Recruiting September 29, 2020 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Objective Response Rate

Primary Outcome 1 - Time Frame: Up to 12 months

Condition:

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Pancreatic Cancer
  • Lung Cancer
  • Head and Neck Cancer
  • Breast Cancer
  • Kidney Cancer
  • Colorectal Cancer
  • Bladder Cancer
  • Ovarian Cancer
  • Sarcoma
  • Gallbladder Cancer
  • Bile Duct Cancer
  • Esophageal Cancer
  • Uterine Cancer
  • Cholangiocarcinoma
  • Prostate Cancer

Eligibility

Criteria:
Inclusion Criteria:

To be eligible for participation in the study, patients must meet the following inclusion
criteria:

- Locally-advanced or metastatic solid tumor with an NRG1 gene fusion identified through
molecular assays, such as PCR, NGS (RNA or DNA) or FISH, by a CLIA-certified or
similarly accredited laboratory

- Availability of fresh or archived FFPE tumor sample to be submitted to a central
laboratory for confirmation of NRG1 gene fusion status

- Patients should have received a minimum of one prior standard therapy appropriate for
their tumor type and stage of disease, progressed or been nonresponsive to these
available therapies, with no further available curative therapy options

- ≥ 18 years of age

- ECOG performance status (PS) 0, 1 or 2

- Patients must have at least one measurable extra-cranial lesion as defined by RECIST
v1.1

- Adequate hepatic function defined as:

- Serum AST and serum ALT < 2.5 × upper limit of normal (ULN), or AST and ALT < 5 × ULN
if liver function abnormalities due to underlying malignancy

- Total bilirubin < 2.0 ULN. Subjects with a known history of Gilberts Disease and an
isolated elevation of indirect bilirubin are eligible

- Adequate hematologic status, defined as:

- Absolute neutrophil count (ANC) ≥1.5 × 109/L not requiring growth factor support for
at least 7 days prior to Screening, and

- Platelet count ≥100.0×109/L not requiring transfusion support for at least 7 days
prior to Screening

- Able to provide informed consent or have a legal representative able and willing to do
so

- Ability to comply with outpatient treatment, laboratory monitoring, and required
clinic visits for the duration of study participation

- Willingness of men and women of reproductive potential to observe conventional and
effective birth control for the duration of treatment and for 3 months following study
completion; this may include barrier methods such as condom or diaphragm with
spermicidal gel.

Exclusion Criteria:

- Known, actionable oncogenic driver mutation other than NRG1 fusion where available
standard therapy is indicated

- Life expectancy < 3 months

- Pregnant or lactating

- Prior treatment with ERBB3/HER3 directed therapy (Cohort 1 only)

- Prior treatment with pan-ERBB or any ERBB/HER2/HER3 directed therapy (Cohort 1 only)

- Symptomatic or untreated brain metastases (Note: Patients with asymptomatic brain
metastases treated with radiation or surgery and without evidence of progression by
imaging at screening are eligible to participate in the study. Patients requiring
ongoing corticosteroids to treat brain metastases will not be eligible).

- Received other investigational agent or anticancer therapy within 28 days prior to
planned start of seribantumab or 5 half-lives, whichever is shorter

- Prior to initiation of seribantumab treatment, patients must have recovered from
clinically significant toxicities from prior anticancer or investigational therapy

- Any other active malignancy requiring systemic therapy

- Known hypersensitivity to any of the components of seribantumab or previous CTCAE
grade 3 or higher hypersensitivity reactions to fully human monoclonal antibodies

- Clinically significant cardiac disease, including symptomatic congestive heart
failure, unstable angina, acute myocardial infarction within 12 months of planned
first dose, or unstable cardiac arrhythmia requiring therapy (including torsades de
pointes)

- Active uncontrolled systemic bacterial, viral, or fungal infection

- Patients who are not appropriate candidates for participation in this clinical study
for any other reason as deemed by the investigator
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: VP, Clinical Operations

Phone: 716-371-1125

Email: clinical@elevationoncology.com

Locations

Facility Status Contact
Compassionate Care Research Group Inc.
Fountain Valley, California 92708
United States
Recruiting
714-698-0300
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United States
Recruiting
877-726-5130
Henry Ford
Detroit, Michigan 48202
United States
Recruiting
313-916-3721
CTOResearch@hfhs.org
Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Recruiting
800-600-3606
info@siteman.wustl.edu
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Misty Moore

Misty.Moore@scresearch.net
The University of Texas M.D. Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Recruiting
Northwest Medical Specialties, PLLC
Tacoma, Washington 98405
United States
Recruiting Study Coordinator
253-428-8750
University of Wisconsin
Madison, Wisconsin 53792
United States
Recruiting
800-323-8942