Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Zongertinib for Metastatic Breast Cancer

This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful.

Official registry: https://clinicaltrials.gov/study/NCT06324357 · Boehringer Ingelheim · enrollment listed as 910

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, Trastuzumab deruxtecan, or Trastuzumab emtansine. The registry lists allocation as randomized. This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery.

They plan to enroll about 910 people at 103 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)

Interventions: Zongertinib, Trastuzumab deruxtecan, Trastuzumab emtansine, Trastuzumab, Capecitabine, mFOLFOX6, zanidatamab, Docetaxel

Primary outcome (registry wording): Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Cohorts A to K and Cohort O and P: Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma (mGEAC)
  • Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression/amplification
  • For (Phase II): Patient must provide tumor tissue
  • History of prior treatment lines in palliative setting: For cohorts A, B, C, D, E, F, G, H, I, I-ext, J, J-ext, K, O and P documented investigator assessed progression
  • Presence of at least one measurable lesion according to RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Adequate organ function based on laboratory values Further who can join apply

Public study contact (from the registry)

Boehringer Ingelheim

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

103 listed

+ 77 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06324357 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 NCT06324357?

Phase 1 / 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 NCT06324357?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary