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

Phase 2

Recruiting

• Conditions: Solid Tumours
• Interventions: Drug: Zongertinib

• Registration Number: NCT06581432
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a study for people with advanced cancer for whom previous treatment was not successful or no treatment exists. 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 10 groups based on the type of advanced cancer and the type of HER2 alterations they have. All participants take one dose of zongertinib. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Study First Posted: 2024-09-03
• Study Start: 2024-10-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2027-09-02
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zongertinib treatment	Zongertinib	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with objective response (OR)	Up to 37 months	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.

Secondary Outcome Measures

Name	Time	Method
Duration of objective response (DOR)	Up to 37 months	Duration of objective response (DOR) is defined as the time from first documented confirmed 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.
Progression-Free Survival (PFS)	Up to 37 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.
Disease control (DC)	Up to 37 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.
Occurrence of treatment-emergent Adverse Events (AEs)	Up to 37 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, item list (EORTC IL19)	At baseline and up to 48 weeks	The EORTC IL19 consists of five physical functioning scale items. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".

Trial Locations

Locations (26)

Alliance Cancer Specialists, PC, Wynnewood; 🇺🇸 Wynnewood, Pennsylvania, United States

University of Arizona Comprehensive Cancer Center; 🇺🇸 Phoenix, Arizona, United States

Scripps Cancer Center Torrey Pines; 🇺🇸 La Jolla, California, United States

Valkyrie Clinical Trials; 🇺🇸 Los Angeles, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Illinois Cancer Specialists; 🇺🇸 Arlington Heights, Illinois, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Virginia Cancer Specialists, PC; 🇺🇸 Fairfax, Virginia, United States

VCU Health Community Memorial Hospital; 🇺🇸 South Hill, Virginia, United States

Edegem - UNIV UZ Antwerpen; 🇧🇪 Edegem, Belgium

BC Cancer Agency - Vancouver; 🇨🇦 Vancouver, British Columbia, Canada

Shanghai East Hospital; 🇨🇳 Shanghai, China

CTR Georges-François Leclerc; 🇫🇷 Dijon, France

INS Gustave Roussy; 🇫🇷 Villejuif, France

Universitätsklinikum Mannheim GmbH; 🇩🇪 Mannheim, Germany

Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 München, Germany

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Italy

AOU Università degli Studi della Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy

Aichi Cancer Center Hospital; 🇯🇵 Aichi, Nagoya, Japan

National Cancer Center Hospital East; 🇯🇵 Chiba, Kashiwa, Japan

Osaka International Cancer Institute; 🇯🇵 Osaka, Osaka, Japan

Shizuoka Cancer Center; 🇯🇵 Shizuoka, Sunto-gun, Japan

Nederlands Kanker Instituut; 🇳🇱 Amsterdam, Netherlands

Radboud Universitair Medisch Centrum; 🇳🇱 Nijmegen, Netherlands