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Monoclonal Antibodies

Zongertinib + Trastuzumab Combinations for HER2+ Breast Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Patients must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF
Must not have
History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator. Myocardial infarction (or troponin levels consistent with myocardial infarction within 28 days of randomization), stroke, or pulmonary embolism within 6 months prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 50 months
Awards & highlights

Summary

This trial is for adults with a specific type of cancer that has spread and cannot be removed by surgery. The purpose is to find the best dose of a drug called zongertinib that can

Who is the study for?
Adults aged 18+ with HER2+ metastatic breast or gastric cancer that's spread and can't be surgically removed. Participants must have tried other treatments without success, have at least one measurable tumor, and an ECOG score of 0 or 1 indicating they are fully active or restricted in physically strenuous activity but ambulatory.
What is being tested?
The trial is testing the drug Zongertinib combined with either Trastuzumab Deruxtecan (T-DXd) or Trastuzumab Emtansine (T-DM1) to find a tolerable dose and see if it shrinks tumors in HER2+ cancers. It has two parts: increasing doses of Zongertinib (Part 1), then random groups receiving different doses (Part 2).
What are the potential side effects?
Potential side effects include reactions related to the immune system, infusion-related responses, fatigue, nausea, liver issues, blood cell count changes which could lead to increased infection risk. Specific side effect profiles will depend on the treatment combination received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or have some restrictions but can still care for myself.
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I am 18 years old or older, or at the legal age of consent in my country.
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My cancer is HER2 positive and has spread to other parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart problems or recent major heart events.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 50 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 50 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Dose optimization (Phase II): Objective response (OR)
Secondary outcome measures
Dose optimization (Phase II): Disease control (DC)
Dose optimization (Phase II): Patient-reported outcome (PRO) - EORTC IL19
Dose optimization (Phase II): Patient-reported outcome (PRO) - EORTC IL46
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecanExperimental Treatment2 Interventions
Dose escalation (Phase Ib)
Group II: Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecanExperimental Treatment2 Interventions
Dose escalation (Phase Ib)
Group III: Phase Ib - Cohort A: zongertinib + Trastuzumab emtansineExperimental Treatment2 Interventions
Dose escalation (Phase Ib)
Group IV: Phase II - Cohort F: zongertinib + Trastuzumab deruxtecanExperimental Treatment2 Interventions
Dose optimization (Phase II).
Group V: Phase II - Cohort E: zongertinib + Trastuzumab deruxtecanExperimental Treatment2 Interventions
Dose optimization (Phase II).
Group VI: Phase II - Cohort D: zongertinib + Trastuzumab emtansineExperimental Treatment2 Interventions
Dose optimization (Phase II).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zongertinib
2024
Completed Phase 1
~60
Trastuzumab emtansine
2010
Completed Phase 4
~2220
Trastuzumab deruxtecan
2022
Completed Phase 2
~580

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,534 Previous Clinical Trials
11,357,287 Total Patients Enrolled
~160 spots leftby Feb 2027
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