CLINICAL_TRIALS ClinicalTrials.gov record update

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)

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT06324357
Title field or adapter rule: {'original_value': '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)', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:30.096664+00:00
Published At: 2026-10-28T00:00:00+00:00
Record Updated At: 2026-10-28
Source Retrieved At: 2026-10-31T22:18:28.651351+00:00
Timestamp Basis: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions: ["Metastatic Breast Cancer", "Metastatic Gastric Adenocarcinoma", "Gastroesophageal Junction Adenocarcinoma", "Esophageal Adenocarcinoma", "Colorectal Cancer"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-28", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT06324357"
protocolSection.identificationModule.officialTitle: "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)"
protocolSection.statusModule.overallStatus: "RECRUITING"
protocolSection.designModule.phases: ["PHASE1", "PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

Study condition terms

Interventions recorded in this study

{'armGroupLabels': ['Phase II - Cohort D: zongertinib + Trastuzumab emtansine', 'Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan', 'Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan', 'Phase II - Cohort H: zongertinib + trastuzumab + capecitabine', 'Phase II - Cohort I-ext: zongertinib', 'Phase II - Cohort I: zongertinib', 'Phase II - Cohort J-ext: zongertinib + trastuzumab', 'Phase II - Cohort J: zongertinib + trastuzumab', 'Phase II - Cohort L-ext: zongertinib + trastuzumab', 'Phase II - Cohort L: zongertinib + trastuzumab', 'Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine', 'Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan', 'Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan', 'Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine', 'Phase Ib - Cohort K: zongertinib + trastuzumab', 'Phase Ib - Cohort M: zongertinib + mFOLFOX6', 'Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6', 'Phase Ib - Cohort O: zongertinib + zanidatamab', 'Phase Ib - Cohort P: zongertinib + zanidatamab + docetaxel'], 'description': 'Zongertinib', 'name': 'Zongertinib', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan', 'Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan', 'Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan', 'Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan'], 'description': 'Trastuzumab deruxtecan', 'name': 'Trastuzumab deruxtecan', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase II - Cohort D: zongertinib + Trastuzumab emtansine', 'Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine'], 'description': 'Trastuzumab emtansine', 'name': 'Trastuzumab emtansine', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase II - Cohort H: zongertinib + trastuzumab + capecitabine', 'Phase II - Cohort J-ext: zongertinib + trastuzumab', 'Phase II - Cohort J: zongertinib + trastuzumab', 'Phase II - Cohort L-ext: zongertinib + trastuzumab', 'Phase II - Cohort L: zongertinib + trastuzumab', 'Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine', 'Phase Ib - Cohort K: zongertinib + trastuzumab', 'Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6'], 'description': 'Trastuzumab', 'name': 'Trastuzumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase II - Cohort H: zongertinib + trastuzumab + capecitabine', 'Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine'], 'description': 'Capecitabine', 'name': 'Capecitabine', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase Ib - Cohort M: zongertinib + mFOLFOX6', 'Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6'], 'description': 'mFOLFOX6 (oxaliplatin, calcium folinate, 5-fluorouracil)', 'name': 'mFOLFOX6', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase Ib - Cohort O: zongertinib + zanidatamab', 'Phase Ib - Cohort P: zongertinib + zanidatamab + docetaxel'], 'description': 'zanidatamab', 'name': 'zanidatamab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase Ib - Cohort P: zongertinib + zanidatamab + docetaxel'], 'description': 'Docetaxel', 'name': 'Docetaxel', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

A recorded drug name is not by itself an indication or a condition-specific relationship.

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