Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread

Conditions

• Colorectal Cancer
• Esophageal Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Metastatic Breast Cancer
• Metastatic Gastric Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zongertinib — DRUG
  Zongertinib
• Trastuzumab deruxtecan — DRUG
  Trastuzumab deruxtecan
• Trastuzumab emtansine — DRUG
  Trastuzumab emtansine
• Trastuzumab — DRUG
  Herceptin®
• Capecitabine — DRUG
  Xeloda®
• mFOLFOX6 — DRUG
  mFOLFOX6
• zanidatamab — DRUG
  zanidatamab

Study Details

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. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow. In this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group. During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.

Key Dates

Start date

Jun 3, 2024

Status verified

May 2026

Primary completion

Jan 8, 2029

Completion

Jan 8, 2029

Study Design

Enrollment

768 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine
  Dose escalation (Phase Ib)
• Experimental: Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan
  Dose escalation (Phase Ib)
• Experimental: Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan
  Dose escalation (Phase Ib)
• Experimental: Phase II - Cohort D: zongertinib + Trastuzumab emtansine
  Dose optimization (Phase II).
• Experimental: Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan
  Dose optimization (Phase II).
• Experimental: Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan
  Dose optimization (Phase II).
• Experimental: Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine
  Dose escalation (Phase Ib)
• Experimental: Phase Ib - Cohort K: zongertinib + trastuzumab
  Dose escalation (Phase Ib)
• Experimental: Phase II - Cohort H: zongertinib + trastuzumab + capecitabine
  Dose optimization (Phase II).
• Experimental: Phase II - Cohort I: zongertinib
  Dose optimization (Phase II).
• Experimental: Phase II - Cohort J: zongertinib + trastuzumab
  Dose optimization (Phase II).
• Experimental: Phase II - Cohort I-ext: zongertinib
  Extension Phase II
• Experimental: Phase II - Cohort J-ext: zongertinib + trastuzumab
  Extension Phase II
• Experimental: Phase Ib - Cohort M: zongertinib + mFOLFOX6
  Dose escalation (Phase Ib)
• Experimental: Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6
  Dose escalation (Phase Ib)
• Experimental: Phase Ib - Cohort O: zongertinib + zanidatamab
  Dose escalation (Phase Ib) - is not conducted in China or South Korea
• Experimental: Phase II - Cohort L: zongertinib + trastuzumab
  Dose justification (Phase II)
• Experimental: Phase II - Cohort L-ext: zongertinib + trastuzumab
  Extension Phase II

Primary Outcome Measure

Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period [ Time Frame: up to 21 days ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (29)

Find similar trials in Phoenix, AZ

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