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Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT04383210•Elevation Oncology

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+5 more criteria

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
+3 more criteria

Locations (42)

University of Alabama at Birmingham

Birmingham, Alabama, United States

HonorHealth

Scottsdale, Arizona, United States

Compassionate Care Research Group Inc.

Fountain Valley, California, United States

Pacific Shores Medical Group

Huntington Beach, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California - Irvine Medical Center

Orange, California, United States

University of Colorado Denver

Denver, Colorado, United States

Medical Oncology Hematology Consultants

Newark, Delaware, United States

Georgetown University

Washington D.C., District of Columbia, United States

Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

September 29, 2020

Primary Completion Date

February 28, 2024

Completion Date

February 28, 2024

Last Updated

April 3, 2025

Enrollment

ACTUAL participants

Conditions

Locally Advanced Solid TumorMetastatic Solid TumorPancreatic CancerLung CancerHead and Neck CancerBreast CancerKidney CancerColorectal CancerBladder CancerOvarian CancerSarcomaGallbladder CancerBile Duct CancerEsophageal CancerUterine CancerCholangiocarcinomaProstate Cancer

Interventions

Seribantumab

DRUG

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RECRUITINGPHASE1/PHASE2

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

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Advanced Malignant Solid NeoplasmLocally Advanced Pancreatic Carcinoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Resilience and Equity in Aging, Cancer, and Health (REACH)

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)