Locally Advanced Solid TumorPhase 2NCT04383210

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

A Phase 2 study testing Seribantumab in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Elevation Oncology at 42 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Locally Advanced Solid Tumor, Metastatic Solid Tumor, Pancreatic Cancer
What is being tested?: Seribantumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 42 sitesin 4 countries
Study dates: 29 Sep 2020to 28 Feb 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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).

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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

Trial locations and contacts

42 sites in 4 countries.

Country

City, postcode or hospital

42 sites in 4 countries

United States35 sites

ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
University Cancer And Blood Center
Athens, Georgia, 30607
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Oncology & Hematology Associates of Southwest Virginia Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Levine Cancer Institute
Charlotte, North Carolina, 28204
Northwestern University
Chicago, Illinois, 60611
The Ohio State University
Columbus, Ohio, 43210
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
University of Colorado Denver
Denver, Colorado, 80220
Henry Ford
Detroit, Michigan, 48202
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Compassionate Care Research Group Inc.
Fountain Valley, California, 92708
Penn State Health Hershey Medical Center Cancer Institute
Hershey, Pennsylvania, 17033
Hawaii Cancer Care
Honolulu, Hawaii, 96813
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Pacific Shores Medical Group
Huntington Beach, California, 92648
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Wisconsin
Madison, Wisconsin, 53792
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Medical Oncology Hematology Consultants
Newark, Delaware, 19713
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
University of California - Irvine Medical Center
Orange, California, 92868
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oregon Health and Science University
Portland, Oregon, 97239
Metro Minnesota CCOP
Saint Louis Park, Minnesota, 55416
Utah Cancer Specialists
Salt Lake City, Utah, 84106
HonorHealth
Scottsdale, Arizona, 85258
Sanford Oncology Clinic
Sioux Falls, South Dakota, 57104
Washington University School of Medicine
St Louis, Missouri, 63110
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Medical Center
The Bronx, New York, 10467
Georgetown University
Washington D.C., District of Columbia, 20007

Other trials in United States

Australia4 sites

Royal Hobart Hospital
Hobart, Tasmania, 7000
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Linear Clinical Research Ltd.
Nedlands, Western Australia, 6009
St. Vincent's Hospital
Sydney, New South Wales, 2010

Other trials in Australia

Canada2 sites

William Osler Health System
Brampton, Ontario, L6R 3J7
BC Cancer
Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

South Korea1 site

Seoul National University Hospital
Seoul, 03080

Other trials in South Korea

About this study

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

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.

Conditions: Locally Advanced Solid Tumor, Metastatic Solid Tumor, Pancreatic Cancer, Lung Cancer, Head and Neck Cancer, Breast Cancer
Being tested: Seribantumab
Keywords: NRG1, Neuregulin 1, Gene fusion
Medical subject headings: Neoplasm Metastasis, Pancreatic Neoplasms, Lung Neoplasms, Head and Neck Neoplasms, Breast Neoplasms, Kidney Neoplasms, Colorectal Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SeribantumabDrug
Anti-HER3 monoclonal antibody

Study groups in NCT04383210
Study group	Role	What they receive
Cohort 1	Experimental	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. Receives: Drug: Seribantumab
Cohort 2	Experimental	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. Receives: Drug: Seribantumab
Cohort 3	Experimental	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. Receives: Drug: Seribantumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate
Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1, for seribantumab monotherapy (3,000 mg QW) in patients with centrally confirmed NRG1 fusion.
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 202028 Feb 2024

First posted12 May 2020
Study start29 Sep 2020
Primary completion28 Feb 2024
Study completion28 Feb 2024

Why it stopped: Business decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Locally Advanced Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04383210
Sponsor's protocol ID: ELVCAP-001-01
Status last verified: Mar 2025
First submitted: 7 May 2020
Last updated: 3 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Patil T, Lin JJ, Cheema PK, Carrizosa DR, Burkard ME, Elamin YY, Desai J, Patel JD, Nagasaka M, Reckamp KL, Waqar SN, Bauman JR, Schram AM, Gadgeel SM, Ma PC, Konduri K, Nguyen D, Misleh J, Bleeker J, Weiss M, Thavaneswaran S, Haura EB, Deegan M, Kaufman J, Srivastava J, Jansen VM, Liu SV. CRESTONE: A Phase II Study of the Efficacy and Safety of the HER3 Monoclonal Antibody, Seribantumab, in Solid Tumors With Neuregulin-1 (NRG1) Fusions. JCO Precis Oncol. 2025 Aug;9:e2500221. doi: 10.1200/PO-25-00221. Epub 2025 Dec 22.
PubMed 41428976

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
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Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
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Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced Solid Tumors, Recurrent Solid Tumors

All Locally Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients With Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT04383210
Acronym / sponsor ID: ELVCAP-001-01
Conditions: Locally Advanced Solid Tumor, Metastatic Solid Tumor, Pancreatic Cancer, Lung Cancer, Head and Neck Cancer, Breast Cancer
Keywords: NRG1, Neuregulin 1, Gene fusion
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision
Enrolment: 54 participants (actual)
Lead sponsor: Elevation OncologyIndustry (pharma, biotech, devices)
Study start: 29 Sep 2020 (actual)
Primary completion: 28 Feb 2024 (actual)
Study completion: 28 Feb 2024 (actual)
First posted: 12 May 2020 (actual)
Results: Posted 3 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1	Experimental	Drug: SeribantumabA 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.
Cohort 2	Experimental	Drug: SeribantumabUp 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.
Cohort 3	Experimental	Drug: SeribantumabUp 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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

Key exclusion criteria (13 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SeribantumabAnti-HER3 monoclonal antibody	Drug	Cohort 1, Cohort 2, Cohort 3

Primary outcome

Objective Response Rate
Time frame: Up to 12 months
Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1, for seribantumab monotherapy (3,000 mg QW) in patients with centrally confirmed NRG1 fusion.

Results and safety

Results posted to the registry on 3 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	36	36
Cohort 2	11	11
Cohort 3	7	7

Primary outcome: Objective Response Rate

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	Cohort 1 n = 29	Cohort 2 n = 10	Cohort 3 n = 6
Value	10	1	0

Population analysed: Among the 36 patients enrolled in Cohort 1, 29 of 36 patients met criteria (criteria includes centrally confirmed NRG1 fusion status and patient received 3,000 mg QW dosing) to be included in the primary efficacy population and were evaluable for investigator assessed response per RECIST v1.1. In Cohorts 2 and 3, one patient in each cohort was not evaluable for investigator assessed response per RECIST v1.1.

Adverse events

Time frame: 3 years, 4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	17 of 36 (47.2%)	35 of 36 (97.2%)	21 of 36
Cohort 2	6 of 11 (54.5%)	11 of 11 (100%)	8 of 11
Cohort 3	4 of 7 (57.1%)	7 of 7 (100%)	7 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41428976Patil T, Lin JJ, Cheema PK, Carrizosa DR, Burkard ME, Elamin YY, Desai J, Patel JD, Nagasaka M, Reckamp KL, Waqar SN, Bauman JR, Schram AM, Gadgeel SM, Ma PC, Konduri K, Nguyen D, Misleh J, Bleeker J, Weiss M, Thavaneswaran S, Haura EB, Deegan M, Kaufman J, Srivastava J, Jansen VM, Liu SV. CRESTONE: A Phase II Study of the Efficacy and Safety of the HER3 Monoclonal Antibody, Seribantumab, in Solid Tumors With Neuregulin-1 (NRG1) Fusions. JCO Precis Oncol. 2025 Aug;9:e2500221. doi: 10.1200/PO-25-00221. Epub 2025 Dec 22.
Individual participant dataSharing planned: No

Related trials for Locally Advanced Solid Tumor

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

42 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Seribantumab in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Elevation Oncology at 42 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Australia, Canada, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04383210, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.