Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations

NCT06581432
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
588
clinicaltrials.gov
Lead sponsor
Boehringer Ingelheim
clinicaltrials.gov
Start date
2024-10-11
clinicaltrials.gov
Number of sites
89
clinicaltrials.gov

Summary
This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2. Participants are put into groups based on the type of advanced cancer they have, the type of HER2 alterations they have, and the dose of zongertinib they receive. Depending on the group they are in, participants take 1 of 2 different doses of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it. Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.
clinicaltrials.gov
Short title
Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
clinicaltrials.gov
Official title
Beamion PANTUMOR-1: A Phase II, Multicentre, Multicohort, Open-label Trial to Evaluate the Efficacy and Safety of Oral Zongertinib (BI 1810631) for the Treatment of Selected HER2-mutated or Overexpressed/Amplified Solid Tumours
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2028-12-29
clinicaltrials.gov
First posted
2024-09-03
clinicaltrials.gov
Registry last updated
2026-08-19
clinicaltrials.gov
Primary completion date
2028-11-30
clinicaltrials.gov
Start date
2024-10-11
clinicaltrials.gov

Participants
588
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
588
clinicaltrials.gov
Protocol amendments
6
clinicaltrials.gov
Number of sites
89
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Boehringer Ingelheim
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06581432
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06581432
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Proportion of patients with objective response (OR)

    Timeframe: Up to 51 months

    according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 by central independent review, and it will be summarised descriptively as absolute and relative frequencies

  1. Duration of objective response (DOR)

    Timeframe: Up to 51 months

    Duration of objective response (DOR) is defined as the time from first documented Objective response (OR) according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed OR, assessed by central independent review.

  2. Progression-Free Survival (PFS)

    Timeframe: Up to 51 months

    PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST 1.1 assessed by central independent review, or death from any cause, whichever occurs first.

  3. Disease control (DC)

    Timeframe: Up to 51 months

    Disease control (DC) is defined as best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) where BOR is defined according to RECIST 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by central independent review.

  4. Occurrence of treatment-emergent Adverse Events (AEs)

    Timeframe: Up to 51 months

  5. Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, of the EORTC QLQ-C30, which includes IL-19, the physical functioning scale

    Timeframe: At baseline and up to 48 weeks

    QLQ-C30 incorporates both multi-items scales and single-item measures. These include 1 global health status/QoL scale, 5 functional scales, 3 symptoms scales and 6 single items to assess dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. European Organisation for Research and Treatment of Cancer, quality-of-life questionnaire (EORTC QLQ-C30) does not produce a single overall summary score by default. Scores can be reported via domain-specific scores or summary score (since 2016) ranging from 0 to 100 with higher scores representing a better QoL.

  6. Overall survival (OS)

    Timeframe: Up to 51 months

    OR is defined as the time from start of treatment to death from any cause

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

  • 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 Informed consent form (ICF).

  • Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of:

    • HER2 amplification
    • Known activating HER2 mutations

  • Availability and willingness to provide a sample of archival formalin-fixed paraffin embedded (FFPE) tumour tissue material

  • Patient with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumour who has had at least one prior line of therapy for metastatic disease. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.

Further inclusion criteria apply.

  • Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC)

  • Previous or concomitant malignancies other than the 1 treated in this trial within the previous 3 years except:

    • effectively treated non-melanoma skin cancers
    • effectively treated carcinoma in situ of the cervix
    • effectively treated ductal carcinoma in situ of the breast
    • localised prostate cancer on watchful waiting or active surveillance
    • other effectively treated malignancy that is considered cured by local treatment.

  • 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

  • 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 Further exclusion criteria apply.

Sources for eligibility
clinicaltrials.gov

  • Alaska Oncology and Hematology, LLCAnchorage, United StatesRecruiting
  • University of Arizona Comprehensive Cancer CenterTucson, United StatesCompleted
  • Precision NextGen OncologyBeverly Hills, United StatesRecruiting
  • Scripps Cancer Center Torrey PinesLa Jolla, United StatesRecruiting
  • Valkyrie Clinical TrialsLos Angeles, United StatesRecruiting
  • Yale University School of MedicineNew Haven, United StatesRecruiting
  • BRCR GlobalTamarac, United StatesRecruiting
  • Illinois Cancer SpecialistsArlington Heights, United StatesRecruiting
  • Community MD Anderson Cancer Center - East Medical OncologyIndianapolis, United StatesRecruiting
  • Maryland Oncology Hematology, ColumbiaColumbia, United StatesRecruiting
  • Karmanos Cancer InstituteDetroit, United StatesCompleted
  • Presbyterian Healthcare ServicesAlbuquerque, United StatesRecruiting
  • Icahn School of Medicine at Mount SinaiNew York, United StatesRecruiting
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesRecruiting
  • Taylor Cancer Research CenterMaumee, United StatesRecruiting
  • Alliance Cancer Specialists, PC, WynnewoodWynnewood, United StatesRecruiting
  • Sarah Cannon Research Institute at Mary CrowleyDallas, United StatesRecruiting
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • Texas Oncology - Plano WestPlano, United StatesRecruiting
  • Virginia Cancer Specialists, PCFairfax, United StatesRecruiting
  • Macquarie UniversityMacquarie Park, AustraliaRecruiting
  • GenesisCare North ShoreSt Leonards, AustraliaRecruiting
  • Princess Alexandra HospitalWoolloongabba, AustraliaRecruiting
  • Cancer Research South AustraliaAdelaide, AustraliaNot yet recruiting
  • St John of God Subiaco HospitalSubiaco, AustraliaRecruiting

And 64 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-510429-14-00
  • U1111-1302-3333
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)