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Brief Title: Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors

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

INTRODUCTION

  • Org Study ID: ELVCAP-001-01
  • Secondary ID: N/A
  • NTC ID: NCT04383210
  • Sponsor: 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.

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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Objective Response Rate

Primary Outcome 1 - Timeframe: 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

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 716-371-1125, 716-371-1125

Email: clinical@elevationoncology.com, medicalaffairs@elevationoncology.com

LOCATION

Facility Status Contact
Facility: University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Status: Recruiting Contact: Contact
Eddy Yang, MD, PhD
714-698-0300
CTOResearch@hfhs.org
Facility: HonorHealth
Scottsdale, Arizona 85258
United States
Status: Recruiting Contact: Contact
Frank Tsai, MD
877-726-5130
info@siteman.wustl.edu
Facility: Compassionate Care Research Group Inc.
Fountain Valley, California 92708
United States
Status: Recruiting Contact: Contact
Haresh Jhangiani, MD
313-916-3721
Misty.Moore@scresearch.net
Facility: Pacific Shores Medical Group
Huntington Beach, California 92648
United States
Status: Recruiting Contact: Principal Investigator
Danny Nguyen, MD
800-600-3606
Facility: Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Status: Recruiting Contact: Contact
Karen Reckamp, MD
253-428-8750
Facility: University of California - Irvine Medical Center
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Viola Zhu, MD
800-323-8942
Facility: University of Colorado Denver
Denver, Colorado 80220
United States
Status: Recruiting Contact: Contact
Tejas Patil, MD

Facility: Georgetown University
Washington, District of Columbia 20007
United States
Status: Recruiting Contact: Contact
Stephen Liu, MD

Facility: AdventHealth Orlando
Orlando, Florida 32806
United States
Status: Recruiting Contact: Contact
Mark Socinski, MD

Facility: Moffitt Cancer Center
Tampa, Florida 33612
United States
Status: Recruiting Contact: Contact
Eric Haura, MD

Facility: University Cancer And Blood Center
Athens, Georgia 30607
United States
Status: Recruiting Contact: Contact
Gustavo Westin, MD

Facility: Northwestern University
Chicago, Illinois 60611
United States
Status: Recruiting Contact: Contact
Young Chae, MD

Facility: Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United States
Status: Recruiting Contact: Contact
Jessica Lin, MD

Facility: Henry Ford
Detroit, Michigan 48202
United States
Status: Recruiting Contact: Contact
Shirish M. Gadgeel, MD

Facility: Metro Minnesota CCOP
Saint Louis Park, Minnesota 55416
United States
Status: Recruiting Contact: Principal Investigator
Dan Anderson, MD

Facility: Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Contact
Saiama N. Waqar, MD

Facility: Montefiore Medical Center
Bronx, New York 10467
United States
Status: Recruiting Contact: Principal Investigator
Balasz Halmos, MD

Facility: Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact: Contact
Daniel Carrizosa, MD

Facility: The Ohio State University
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Contact
Greg Otterson, MD

Facility: Oregon Health and Science University
Portland, Oregon 97239
United States
Status: Recruiting Contact: Principal Investigator
Shivaani Kummar, MD

Facility: Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
Misty Moore

Facility: The University of Texas M.D. Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
David R. Spigel, MD

Facility: Utah Cancer Specialists
Salt Lake City, Utah 84106
United States
Status: Recruiting Contact: Contact
Yasir Elamin, MD

Facility: Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
S. Disean Kendall, MD

Facility: Northwest Medical Specialties, PLLC
Tacoma, Washington 98405
United States
Status: Recruiting Contact: Contact
Alexander I. Spira, MD

Facility: University of Wisconsin
Madison, Wisconsin 53792
United States
Status: Recruiting Contact: Principal Investigator
Study Coordinator

Facility: William Osler Health System
Brampton, Ontario L6R 3J7
Canada
Status: Recruiting Contact: Principal Investigator
Frank M. Senecal, MD