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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04383210
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Elevation Oncology

Tracking Information
First Submitted Date  ICMJE May 7, 2020
First Posted Date  ICMJE May 12, 2020
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE September 29, 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
Objective Response Rate [ Time Frame: Up to 12 months ]
The primary objective of this study is to determine the overall objective response rate (ORR) by independent radiologic review to single agent seribantumab in patients with NRG1 gene fusion positive advanced cancer according to RECIST 1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
Official Title  ICMJE CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients With Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: Seribantumab
Anti-HER3 monoclonal antibody
Study Arms  ICMJE
  • Experimental: Cohort 1

    A minimum of 55 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy.

    Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.

    Intervention: Drug: Seribantumab
  • Experimental: Cohort 2

    Up to 10 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy.

    Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.

    Intervention: Drug: Seribantumab
  • Experimental: Cohort 3

    Up to 10 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy.

    Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.

    Intervention: Drug: Seribantumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: VP, Clinical Operations 716-371-1125 clinical@elevationoncology.com
Contact: VP, Medical Affairs 716-371-1125 medicalaffairs@elevationoncology.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04383210
Other Study ID Numbers  ICMJE ELVCAP-001-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elevation Oncology
Study Sponsor  ICMJE Elevation Oncology
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Elevation Oncology
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP