BridgeMD
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
EU CTIS ID: 2023-509566-38-00
What this study is testing
Dose escalation (Phase Ib) To characterize the safety, tolerability, and the dose-toxicity curve of zongertinib: o in combination with T-DM1 in patients with HER2+ mBC (Cohort A) o in combination with T-DXd in patients with HER2+ mBC (Cohort B) o in combination with T-DXd in patients with mGEAC (Cohort C) o in combination with capecitabine and trastuzumab in patients with HER2+ mBC (Cohort G) o in combination with trastuzumab in patients with HER2+ mBC (Cohort K) o in combination with mFOLFOX6 in patients with HER2+ mCRC (Cohort M) o in combination with trastuzumab and mFOLFOX6 in patients with HER2+ mCRC (Cohort N) o in combination with zanidatamab in patients with HER2+ mBC (Cohort O) by assessing escalating dose levels with overdose control to achieve primary objective of determining maximum tolerated doses (MTDs) and/or doses for further development per cohort To evaluate number of patients with "redacted as CCI" within MTD evaluation period per dose level. The MTD evaluation period is defined as the first 21 days of the first treatment cycle for Cohorts A, B, C, G, K, and O. The MTD evaluation period is defined as the first 28 days after the first administration of any trial medication for Cohorts M and N. The MTD is to be determined by dose escalation committee (DEC) based on the totality of data. It may be chosen as the highest dose with less than 25% risk of the true DLT rate being equal to or above 33% during MTD evaluation period based on the Bayesian Logistic Regression Model (BLRM) with overdose control (escalation with overdose control [EWOC]) for the trial The primary characterization of primary objective will be based on initial dose administered to patient during the MTD evaluation period and the strategy for handling intercurrent events will be a combined composite and principal stratum approach where some intercurrent events are considered as outcome and some define population consisting of patients who are able to adhere to the assigned treatment regimen and trial schedule Dose optimization and justification (Phase II) To assess anti-tumor activity of zongertinib in the following settings to assist in selection of optimal dose for further clinical development: o in combination with T-DM1 in patients with HER2+ mBC (Cohort D) o in combination with T-DXd in patients with HER2+ mBC (Cohort E) o in combination with T-DXd in patients with HER2+ mGEAC (Cohort F) o in combination with capecitabine and trastuzumab in patients with HER2+ mBC (Cohort H) o as a monotherapy in patients with HER2+ mBC (Cohort I, I-ext) o in combination with trastuzumab in patients with HER2+ mBC (Cohort J, J-ext) o in combination with trastuzumab in patients with HER2+ mCRC (Cohort L, L-ext) The primary endpoint is proportion of patients with objective response (OR) by RECIST version 1.1 as assessed by investigator review in the intent-to-treat population The summary measure of OR will include all treated patients regardless of breaks from trial treatment but will exclude the effects of any subsequent anti-cancer therapy started before progression
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥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 informed consent form (ICF)
- Cohorts A to K and Cohort O: Documented HER2+ mBC or mGEAC
- Cohorts L (L-ext), M, and N (mCRC): Documented HER2 overexpression/amplification
- For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival 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 and O documented investigator assessed progression; - For cohorts L, L-ext, M and N documented progression or recurrence of disease during or following their latest line of therapy.
- Presence of at least one measurable lesion according to RECIST 1.1
You likely can't join if
- Mean resting corrected QT interval (QTcF) >470 msec.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, personal or family history of long QT syndrome or unexplained sudden death under 40 years-of-age
- Ejection fraction <50% or the lower limit of normal of the institutional standard within 28 days prior to randomization
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
See the full eligibility criteria
- Patients ≥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 informed consent form (ICF)
- Cohorts A to K and Cohort O: Documented HER2+ mBC or mGEAC
- Cohorts L (L-ext), M, and N (mCRC): Documented HER2 overexpression/amplification
- For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival 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 and O documented investigator assessed progression; - For cohorts L, L-ext, M and N documented progression or recurrence of disease during or following their latest line of therapy.
- 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
- Mean resting corrected QT interval (QTcF) >470 msec.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, personal or family history of long QT syndrome or unexplained sudden death under 40 years-of-age
- Ejection fraction <50% or the lower limit of normal of the institutional standard within 28 days prior to randomization
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- United Kingdom
- United States
- China
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; United Kingdom; United States; China; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.