Beamion LUNG-1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of Zongertinib (BI 1810631) as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations

Who is this study for? Patients with Non-Small Cell Lung Cancer
What treatments are being studied? BI 1810631
Status: Recruiting
Location: See all (85) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must show presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

• Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (ECOG=2 only for Cohorts 6 and 7) .

• Availability and patient willingness to provide a sample of tumour for confirmation of the patient´s Human epidermal growth factor receptor 2 (HER2) status. This sample can be archival material obtained at any time prior to study enrollment.

• Patient willing and able to comply with the protocol requirements for tumour biopsies (biopsies from brain metastases are not allowed).

• Adequate organ function defined as all of the following:

‣ Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (≥ 1.5 x 10\^3/μL) (≥ 1500/mm\^3); haemoglobin ≥ 9.0 g/dL (≥ 90 g/L) (≥ 5.6 mmol/L); platelets ≥ 100 x 10\^9/L (100 x 10\^3/μL) (100 x 10\^3/mm3) without the use of hematopoietic growth factors within 4 weeks of start of trial medication.

⁃ Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN.

⁃ Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min - calculated using Chronic Kidney Disease Epidemiology (CKD-EPI) formula.

⁃ Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.

⁃ Alkaline Phosphatase \< 5 x ULN.

• Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia, stable sensory neuropathy and hypothyroidism (patients on thyroid replacement therapy) which must be ≤ CTCAE Grade 2)

• Life expectancy of at least 12 weeks at the start of treatment in the opinion of the investigator.

• At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years.

• Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

• Male or female patients. Women of childbearing potential (WOCBP) and men who are able to father a child must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.

∙ Additional inclusion criteria for Phase Ia

• Patients with a documented diagnosis of HER2 aberration: overexpression OR gene amplification OR non-synonymous somatic mutation OR gene rearrangement involving HER2 or Neuregulin 1 (NRG1)

• Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted, or not be a suitable candidate for, available treatment options known to prolong survival for their disease

∙ Additional inclusion criteria for Phase Ib - Cohort 1 only

• Non-squamous non-small cell lung cancer (NSCLC) patients with documented human epidermal growth factor receptor 2 (HER2) mutation in the tyrosine kinase domain (TKD) as per local lab results.

• Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with non-squamous NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care.

∙ Additional inclusion criteria for Phase Ib - Cohort 2 only

• Non-squamous NSCLC patient with a documented HER2 mutation in the tyrosine kinase domain (TKD) as per local lab results.

• Treatment naïve for non-squamous NSCLC.

∙ Additional inclusion criteria for Phase Ib - Cohort 3 only

• NSCLC Patient with a documented HER2 mutation outside of the tyrosine kinase domain (TKD) as per local lab results or squamous NSCLC patient with mutation in the TKD as per local lab results.

• Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care.

∙ Additional inclusion criteria for Phase Ib - Cohort 4 only

• NSCLC patients with documented HER2 mutation in the TKD as per local lab results.

• NSCLC patients who are either treatment naïve or who had received any prior line of treatment, in the advanced/metastatic setting. Patients with NSCLC harboring additional genomic aberrations for which approved targeted therapy is available as standard of care.

• Patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.

∙ Additional inclusion criteria for Phase Ib - Cohort 5 only

• Non-squamous NSCLC patients with documented HER2 mutation in the TKD as per local lab results.

• Patient should have received, in the advanced/metastatic setting, at least one line of systemic therapy that includes a platinum-based combination chemotherapy and should have been treated with previous HER2 directed antibody-drug conjugates (ADC) in the same advanced/metastatic setting and developed disease progression recurrence during or after completing this therapy. Patients with NSCLC harboring additional genomic aberrations for which approved targeted therapy is available as standard of care.

∙ Additional inclusion criteria for Phase Ib - Cohort 6 only

• Non-squamous NSCLC Patient with documented HER2 mutation in the TKD as per local lab results.

• Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy.

• Patient without active brain metastases or patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.

• Patient who is not eligible for any other recruiting cohort.

∙ Additional inclusion criteria for Phase Ib - Cohort 7 only

• Non-squamous NSCLC patient with documented HER2 mutation in the TKD as per local lab results.

• Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy.

• Patient without active brain metastases or patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.

• Patient who is not eligible for any other recruiting cohort.

∙ Additional inclusion criteria for Phase Ib - Cohort 8 only

• Treatment naïve for NSCLC

• NSCLC (adenocarcinoma or squamous) patient with documented HER2 mutation in the tyrosine kinase domain (TKD) or non-squamous NSCLC with a documented HER2 mutation in the non tyrosine kinase domain (non TKD) as per local lab results

∙ Further inclusion criteria apply.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
Precision NextGen Oncology
NOT_YET_RECRUITING
Beverly Hills
City of Hope-Duarte-56419
RECRUITING
Duarte
City of Hope - Seacliff
NOT_YET_RECRUITING
Huntington Beach
City of Hope-Irvine-69674
NOT_YET_RECRUITING
Irvine
Valkyrie Clinical Trials
RECRUITING
Los Angeles
University of California Irvine
RECRUITING
Orange
University of California Davis
RECRUITING
Sacramento
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Florida
Holy Cross Hospital-Fort Lauderdale-57892
RECRUITING
Fort Lauderdale
Georgia
Winship Cancer Institute
RECRUITING
Atlanta
Hawaii
Hawaii Cancer Care - Honolulu
RECRUITING
Honolulu
North Carolina
Duke University Medical Center
RECRUITING
Durham
New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Tennessee
Sarah Cannon Research Institute-Nashville-48456
RECRUITING
Nashville
Texas
Mary Crowley Cancer Research Center
RECRUITING
Dallas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Virginia
Virginia Cancer Specialists, PC
RECRUITING
Fairfax
Washington
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Other Locations
Australia
Macquarie University
ACTIVE_NOT_RECRUITING
Macquarie Park
Austria
Ordensklinikum Linz GmbH
COMPLETED
Linz
Belgium
Brussels - HOSP Jules Bordet
ACTIVE_NOT_RECRUITING
Anderlecht/brussels-capital
China
Beijing Cancer Hospital
ACTIVE_NOT_RECRUITING
Beijing
Jilin Province Cancer Hospital
COMPLETED
Changchun
The First Hospital of Jilin University
ACTIVE_NOT_RECRUITING
Changchun
Fujian Cancer Hospital
ACTIVE_NOT_RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University
ACTIVE_NOT_RECRUITING
Hangzhou
Zhejiang Cancer Hospital
ACTIVE_NOT_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
The Affiliated Cancer Hospital, Guangxi Medical University
COMPLETED
Nanning
Shanghai Chest Hospital
COMPLETED
Shanghai
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
ACTIVE_NOT_RECRUITING
Wuhan
Wuhan Union Hospital
ACTIVE_NOT_RECRUITING
Wuhan
First Affiliated Hospital of Xiamen University
COMPLETED
Xiamen
Henan Cancer Hospital
ACTIVE_NOT_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
ACTIVE_NOT_RECRUITING
Zhengzhou
France
HOP Louis Pradel
ACTIVE_NOT_RECRUITING
Bron
CTR Leon Berard
ACTIVE_NOT_RECRUITING
Lyon
HOP Timone
ACTIVE_NOT_RECRUITING
Marseille
INS Curie
ACTIVE_NOT_RECRUITING
Paris
HOP Pontchaillou
ACTIVE_NOT_RECRUITING
Rennes
INS Gustave Roussy
ACTIVE_NOT_RECRUITING
Villejuif
Germany
Universitätsklinikum Augsburg
COMPLETED
Augsburg
Universitätsklinikum Köln (AöR)
ACTIVE_NOT_RECRUITING
Cologne
Technische Universität Dresden
ACTIVE_NOT_RECRUITING
Dresden
Justus-Liebig Universität Gießen
ACTIVE_NOT_RECRUITING
Giessen
Pius-Hospital, Oldenburg
ACTIVE_NOT_RECRUITING
Oldenburg
Hong Kong Special Administrative Region
Prince of Wales Hospital-Hong Kong-20715
ACTIVE_NOT_RECRUITING
Hong Kong
Queen Mary Hospital
ACTIVE_NOT_RECRUITING
Hong Kong
Israel
Rambam Medical Center
RECRUITING
Haifa
Meir Medical Center
ACTIVE_NOT_RECRUITING
Kfar Saba
Sourasky Medical Center
ACTIVE_NOT_RECRUITING
Tel Aviv
The Chaim Sheba Medical Center Tel HaShomer
COMPLETED
Tel Litwinsky
Italy
Istituto Di Candiolo
RECRUITING
Candiolo (to)
Istituto Nazionale IRCCS Tumori Fondazione Pascale
COMPLETED
Napoli
Azienda Ospedaliera Unversitaria di Parma
COMPLETED
Parma
Japan
National Cancer Center Hospital East
RECRUITING
Chiba, Kashiwa
Shikoku Cancer Center
RECRUITING
Ehime, Matsuyama
Hiroshima University Hospital
RECRUITING
Hiroshima, Hiroshima
Osaka International Cancer Institute
RECRUITING
Osaka, Osaka
Kindai University Hospital
RECRUITING
Osaka, Osakasayama
Hamamatsu University Hospital
RECRUITING
Shizuoka, Hamamatsu
National Cancer Center Hospital
RECRUITING
Tokyo, Chuo-ku
Netherlands
Nederlands Kanker Instituut
ACTIVE_NOT_RECRUITING
Amsterdam
Leids Universitair Medisch Centrum (LUMC)
ACTIVE_NOT_RECRUITING
Leiden
Portugal
Hospital CUF Porto
ACTIVE_NOT_RECRUITING
Porto
Republic of Korea
Chungbuk National University Hospital
COMPLETED
Chungju
Seoul National University Bundang Hospital
ACTIVE_NOT_RECRUITING
Seongnam
Asan Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Samsung Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Severance Hospital
ACTIVE_NOT_RECRUITING
Seoul
Singapore
National Cancer Centre Singapore
COMPLETED
Singapore
National University Hospital-Singapore-22806
COMPLETED
Singapore
Spain
Hospital Universitari Vall D Hebron
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Duran i Reynals
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Hospital General Universitario Gregorio Marañón
COMPLETED
Madrid
Hospital Universitario 12 de Octubre
ACTIVE_NOT_RECRUITING
Madrid
Hospital Virgen de la Victoria
ACTIVE_NOT_RECRUITING
Málaga
Hospital Clínico de Valencia
ACTIVE_NOT_RECRUITING
Valencia
Sweden
Karolinska Universitetssjukhuset Solna
COMPLETED
Stockholm
United Kingdom
Hammersmith Hospital
ACTIVE_NOT_RECRUITING
London
The Royal Marsden Hospital, Chelsea
ACTIVE_NOT_RECRUITING
London
The Royal Marsden Hospital, Sutton
ACTIVE_NOT_RECRUITING
Sutton
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Backup
Additional US locations available on demand. Please contact for options.
1-800-243-0127
Time Frame
Start Date: 2021-07-02
Estimated Completion Date: 2028-08-30
Participants
Target number of participants: 554
Treatments
Experimental: Phase Ia - Dose escalation part
Consecutive cohorts of patients treated with escalating doses of BI 1810631 monotherapy.
Experimental: Phase Ib - Dose expansion part: Cohort 1
Experimental: Phase Ib - Dose expansion part: Cohort 2
Experimental: Phase Ib - Dose expansion part: Cohort 3
Experimental: Phase Ib - Dose expansion part: Cohort 4
Experimental: Phase Ib - Dose expansion part: Cohort 5
Experimental: Phase Ib - Dose expansion part: Cohort 6
Cohort only in the United States of America (USA)
Experimental: Phase Ib - Dose expansion part: Cohort 7
Cohort only in Japan
Experimental: Phase Ib - Dose expansion part: Cohort 8
Cohort only in the United States of America (USA)
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov

Similar Clinical Trials