Phase 2: testing Zongertinib for Solid Tumours
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.
Official registry: https://clinicaltrials.gov/study/NCT06581432 · Boehringer Ingelheim · enrollment listed as 588
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Zongertinib. The registry lists allocation as na. This is a study for people with advanced cancer for whom previous treatment was not successful.
They plan to enroll about 588 people at 93 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Zongertinib
Primary outcome (registry wording): Proportion of patients with objective response (OR)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Patients aged ≥18 years
- Documented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing)
- Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumours
- Disease progression following prior treatment in the metastatic setting (including treatment with antibody-drug conjugates (ADCs)) and no suitable standard of care treatment options
- Availability of archival tumour tissue sample to confirm HER2 status
- Presence of ≥1 measurable lesion outside the central nervous system (CNS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (investigator assessed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Further who can join apply
Who the registry excludes
- Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer
- Diagnosis of HER2-mutant non-small cell lung cancer (NSCLC)
- Previous treatment with any HER2 tyrosine kinase inhibitors (TKIs)
- Uncontrolled or symptomatic brain or subdural metastases during screening
- Known diagnosis of leptomeningeal disease
- Intake of restricted medications or any drug considered likely to interfere with the trial being conducted in a safe mannerFurther
Public study contact (from the registry)
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
93 listed- Alaska Oncology and Hematology, LLC — Anchorage, Alaska (recruiting)
- University of Arizona Comprehensive Cancer Center — Tucson, Arizona (completed)
- Precision NextGen Oncology — Beverly Hills, California (recruiting)
- Scripps Cancer Center Torrey Pines — La Jolla, California (recruiting)
- Valkyrie Clinical Trials — Los Angeles, California (recruiting)
- Yale University School of Medicine — New Haven, Connecticut (recruiting)
- BRCR Global - Tamarac — Tamarac, Florida (recruiting)
- Illinois Cancer Specialists — Arlington Heights, Illinois (recruiting)
- Community MD Anderson Cancer Center - East Medical Oncology — Indianapolis, Indiana (recruiting)
- Maryland Oncology Hematology, Columbia — Columbia, Maryland (recruiting)
- Karmanos Cancer Institute — Detroit, Michigan (completed)
- Presbyterian Healthcare Services — Albuquerque, New Mexico (recruiting)
+ 73 sites outside the US on the same record
FAQ about this NCT record
Is NCT06581432 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06581432?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06581432?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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