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

  • STATUS
    Recruiting
  • End date
    Jun 9, 2023
  • participants needed
    75
  • sponsor
    Elevation Oncology
Updated on 9 August 2021
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 Malignant neoplasm of prostate, Pancreatic Cancer, Pulmonary Disease, Bile duct carcinoma, Adenocarcinoma, urinary tract neoplasm, Ovarian disorder, Colorectal Cancer, Connective and Soft Tissue Neoplasm, Cholangiocarcinoma, Malignant neoplasm of kidney, Rectal disorder, Nephropathy, Disorder of uterus NOS, Uterine Cancer, Prostatic disorder, Pancreatic disorder, bladder cancer, bladder disorder, Breast Cancer, Biliary neoplasm, Ovarian Cancer, Esophageal Diseases, Esophageal Cancer, Lung Neoplasm, Neoplasm of unspecified nature of digestive system, Sarcoma, Bronchial Neoplasm, head and neck cancer, Malignant neoplasm of gallbladder, Gallbladder Disease, Pancreatic Disorders, Prostate Disorders, All Solid Tumors, Kidney Disease (Pediatric), Colon Cancer Screening, Prostate Cancer, Early, Recurrent, Rectal Disorders, Solid Tumors, Colon cancer; rectal cancer, Ovarian Function, Esophageal Carcinoma, Breast Cancer Diagnosis, Gallbladder Carcinoma, Urothelial Cancer, Recurrent Ovarian Cancer, Locally Advanced Solid Tumor, Metastatic Solid Tumor, Urothelial Tract Cancer, Sarcoma (Pediatric), Islet Ce417ll Cancer, Kidney Cancer, Lung Cancer, Prostate Cancer, Esophageal Disorders, Gall Bladder Disorders, Malignant Adenoma, Kidney Disease, Gall Bladder Cancer, Lung Disease, Bladder Disorders, Uterine Disorders, Biliary Tract Cancer, Renal Cancer, Digestive System Neoplasms, Soft Tissue Sarcoma, Bladder Carcinoma, Urologic Cancer, breast carcinoma, colorectal neoplasm, gallbladder cancer, prostate carcinoma, cancer of the bile duct, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, carcinoma of the bladder, sarcomas, soft tissue sarcomas, cancer, breast, esophagus cancer, oesophageal cancer, colorectal cancers, cancer of the head and neck, cancer of the pancreas, ovarian tumors, cancer, renal, prostate cancers, pancreatic cancers, cancer, pancreatic, cancer, colorectal, colorectal tumor, tumors, colorectal, metastatic malignant solid tumor, cancer of the esophagus, oesophageal carcinoma, bladder tumor, carcinoma lung, lung carcinoma
Treatment Seribantumab
Clinical Study IdentifierNCT04383210
SponsorElevation Oncology
Last Modified on9 August 2021

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
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
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 100.0109/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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