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

  • STATUS
    Recruiting
  • End date
    Jun 18, 2023
  • participants needed
    75
  • sponsor
    Elevation Oncology
Updated on 18 October 2022
platelet count
total bilirubin
absolute neutrophil count
monoclonal antibodies
growth factor
neutrophil count
solid tumors
solid tumor
growth factors

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.

Details
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
Treatment Seribantumab
Clinical Study IdentifierNCT04383210
SponsorElevation Oncology
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

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
ECOG performance status (PS) 0, 1 or 2
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
Adequate hepatic function defined as
available therapies, with no further available curative therapy options
≥ 18 years of age
Adequate hematologic status, defined as
Patients must have at least one measurable extra-cranial lesion as defined by RECIST
v1.1
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
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

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)
Any other active malignancy requiring systemic therapy
Active uncontrolled systemic bacterial, viral, or fungal infection
Known, actionable oncogenic driver mutation other than NRG1 fusion where available
standard therapy is indicated
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
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)
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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How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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