Beamion PANTUMOR-1: A study to test whether zongertinib helps people with advanced cancers with HER2 alterations

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Oct 2024 → ongoing

Decision date (initial)

2024-09-12

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2023-510429-14-00

WHO UTN

U1111-1302-3333

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Assess the anti-tumour activity of zongertinib monotherapy in a variety of HER2-driven solid tumours

Secondary objectives 2

1. Evaluate the efficacy, safety, tolerability, and risk-benefit profile of zongertinib
2. Evaluate patient-reported outcomes (PROs)

Conditions and MedDRA coding

HER2-mutated or overexpressed/amplified solid tumours

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed “Document Sharing Agreement”. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website. Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program. Access Criteria: For study documents – upon signing of a ‚Document Sharing Agreement‘. For study data – 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
2. 2. Patients ≥18 years old or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF.
3. 3. Documented (previously established by local testing) HER2 status of: a. HER2 overexpression/amplification b. Known activating HER2 mutations
4. 4. Availability and willingness to provide a sample of archival formalin-fixed paraffin embedded (FFPE) tumour tissue material
5. 5. Patient atteint d’une tumeur solide localement avancée, non résécable ou métastatique, confirmée histologiquement ou cytologiquement, et qui a déjà reçu au moins une ligne de traitement pour une maladie métastatique. Le patient doit présenter une progression documentée de la maladie ou une récidive pendant ou après la dernière ligne de traitement. Selon l’avis de l’investigateur, les patients doivent être peu susceptibles de tolérer ou de retirer un bénéfice cliniquement significatif d’une autre thérapie standard, connue pour prolonger la survie.
6. Further inclusion criteria apply.

Exclusion criteria 5

1. 1. Diagnosis of HER2 mutant NSCLC (except where there is co-existing presence of HER2 overexpression / amplification).
2. 2. Previous or concomitant malignancies other than the 1 treated in this trial within the previous 3 years except: i. effectively treated non-melanoma skin cancers ii. effectively treated carcinoma in situ of the cervix iii. effectively treated ductal carcinoma in situ of the breast iv.localised prostate cancer on watchful waiting or active surveillance v.other effectively treated malignancy that is considered cured by local treatment.
3. 3. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
4. 4. Not completely recovered from major surgery (major according to the investigator’s assessment) performed prior to screening or planned within 6 months after screening, e.g. hip replacement
5. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients with objective response (OR)

Secondary endpoints 6

1. Duration of objective response (DOR)
2. Progression free survival (PFS)
3. Disease control (DC)
4. Overall survival (OS)
5. Occurrence of treatment-emergent adverse events (AEs)
6. Change from baseline to Week 48 or PD by central independent review, if earlier, in the European Organisation for Research and Treatment of Cancer, (EORTC QLQ-C30)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

Anne Naumann

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

Anne Naumann

Boehringer Ingelheim Espana S.A.

Sponsor organisation

Boehringer Ingelheim Espana S.A.

Address

Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles

City

Barcelona

Postcode

08174

Country

Spain

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

7 EU/EEA countries · 27 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 194 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications