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

Phase 2RecruitingNCT06581432

Boehringer Ingelheim430 enrolled

Overview

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 13 groups based on the type of advanced cancer and the type of HER2 alterations they have. All participants take one dose 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

430

Conditions

Solid Tumours

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

inclusion criteria: * 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 overexpression/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. exclusion criteria: * Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC) (except where there is co-existing presence of HER2 overexpression / amplification) * 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.

Locations (80)

Alaska Oncology and Hematology, LLC

Anchorage, Alaska, United States

RECRUITING

University of Arizona Comprehensive Cancer Center

Tucson, Arizona, United States

NOT_YET_RECRUITING

Precision NextGen Oncology

Beverly Hills, California, United States

RECRUITING

Scripps Cancer Center Torrey Pines

La Jolla, California, United States

Outcomes

Primary Outcomes

Proportion of patients with objective response (OR)

Objective response (OR) is defined as the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as assessed by central independent review, from the date of treatment start until the earliest date of progressive disease (PD), death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or trial treatment discontinuation.

Time frame: Up to 51 months

Secondary Outcomes

Duration of objective response (DOR)

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.

Time frame: Up to 51 months

Progression-Free Survival (PFS)

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.

Time frame: Up to 51 months

Disease control (DC)

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.

Time frame: Up to 51 months

Occurrence of treatment-emergent Adverse Events (AEs)

Time frame: Up to 51 months

Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, in the European Organisation for Research and Treatment of Cancer, quality-of-life questionnaire (EORTC QLQ-C30)

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. 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.

Time frame: At baseline and up to 48 weeks

Overall survival (OS)

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

Time frame: Up to 51 months

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

Overview

Conditions

Interventions

Eligibility

Locations (80)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts