Zongertinib for Solid Tumors

Recruiting in Palo Alto (17 mi)

+92 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Boehringer Ingelheim

Must not be taking: Restricted medications

Disqualifiers: HER2 mutant NSCLC, recent malignancies, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a study for people with advanced cancer for whom previous treatment was not successful or no treatment exists. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2. Participants are put into 10 groups based on the type of advanced cancer and the type of HER2 alterations they have. All participants take one dose of zongertinib. Participants can continue the treatment as long as they benefit from it and can tolerate it. Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes patients who need to continue taking medications that might interfere with the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Zongertinib for solid tumors?

The drug BI 1810631, which is part of Zongertinib, has shown preliminary effectiveness in treating solid tumors with HER2 abnormalities by specifically targeting and binding to HER2 receptors. Additionally, similar drugs like poziotinib and neratinib, which also target HER2, have demonstrated promising results in treating HER2-positive cancers, suggesting potential effectiveness for Zongertinib.

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What makes the drug Zongertinib unique for treating solid tumors?

Zongertinib is unique because it specifically targets HER2 receptors, including certain mutations, without affecting EGFR signaling, which may reduce side effects compared to other treatments that target multiple receptors.

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Eligibility Criteria

Adults over 18 with advanced cancers that have HER2 alterations, which can cause cancer growth. Participants must have tried all other treatments without success or be unsuitable for existing options. They need to provide a tissue sample to confirm HER2 status unless an exception is granted.

Inclusion Criteria

My cancer shows high levels of HER2.

I have signed and understand the consent form for this trial.

My cancer has a known HER2 mutation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral zongertinib and are monitored for tumour size and health effects

Up to 37 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests Zongertinib's effectiveness on various advanced cancers with HER2 alterations. Patients are divided into 10 groups based on their cancer type and specific HER2 changes, and they take Zongertinib as long as it helps them and they can handle it.

Group I: Zongertinib treatment Experimental Treatment 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Alaska Oncology and Hematology, LLC Anchorage, AK

Precision NextGen Oncology Beverly Hills, CA

Memorial Sloan-Kettering Cancer Center New York, NY

Mary Crowley Cancer Research Center Dallas, TX

More Trial Locations

Who Is Running the Clinical Trial?

Boehringer Ingelheim Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations. [2023] BI 1810631 is a human HER2-selective tyrosine kinase inhibitor that covalently binds to both wild-type and mutated HER2 receptors, including exon 20 insertion mutations, whilst sparing EGFR signaling. This phase Ia/Ib, open-label, non-randomized study will determine the safety, maximum tolerated dose (MTD), pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of BI 1810631 in patients with HER2 aberration-positive solid tumors (NCT04886804).

2. Japan pubmed.ncbi.nlm.nih.gov

A phase I/II study of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer. [2023] Poziotinib (HM781-36B) is an irreversible pan-HER tyrosine kinase inhibitor which targets EGFR, HER2, and HER4. This prospective, multicenter, open-label, phase I/II study determined the maximum tolerated dose (MTD) and evaluated the safety and efficacy of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer (GC).

3. England pubmed.ncbi.nlm.nih.gov

Safety, efficacy and pharmacokinetics of neratinib (HKI-272) in Japanese patients with advanced solid tumors: a Phase 1 dose-escalation study. [2022] Neratinib (HKI-272), a potent, irreversible, small-molecule, orally administered, pan-ErbB inhibitor that blocks signal transduction via inhibition of three epidermal growth factor receptors [ErbB1, ErbB2 (Her2) and ErbB4], is being developed for the treatment of solid tumors, including breast cancer. This Phase 1 dose-escalation study assessed the safety, tolerability, maximum-tolerated dose, antitumor activity and pharmacokinetics of neratinib in Japanese patients with advanced solid tumors.

4. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of neratinib (HKI-272) plus vinorelbine in the treatment of patients with ErbB2-positive metastatic breast cancer pretreated with anti-HER2 therapy. [2020] Neratinib (HKI-272) is a potent irreversible pan-ErbB tyrosine kinase inhibitor with clinical activity in patients with ErbB2/HER2-positive breast cancer.

5. United States pubmed.ncbi.nlm.nih.gov

Targeting HER2 May Overtake Chemo, Immunotherapy in NSCLC. [2022] Results from phase II trials of two HER2-targeting agents, the antibody-drug conjugate trastuzumab deruxtecan and the HER2-targeting tyrosine kinase inhibitor poziotinib, indicate promising efficacy that could lead to new standards of care for HER2-mutant non-small cell lung cancer.

6. United States pubmed.ncbi.nlm.nih.gov

Phase I, dose-finding study of AZD8931, an inhibitor of EGFR (erbB1), HER2 (erbB2) and HER3 (erbB3) signaling, in patients with advanced solid tumors. [2021] AZD8931 is an oral equipotent inhibitor of EGFR (erbB1), HER2 (erbB2) and HER3 (erbB3) signaling. This Phase I, open-label study evaluated the safety, tolerability, and pharmacokinetics of multiple ascending doses of AZD8931 in patients with advanced solid tumors (NCT00637039).

7. England pubmed.ncbi.nlm.nih.gov

Phase 1 dose-escalation study of S-222611, an oral reversible dual tyrosine kinase inhibitor of EGFR and HER2, in patients with solid tumours. [2018] S-222611 is a reversible inhibitor of EGFR, HER2 and HER4 with preclinical activity in models expressing these proteins. We have performed a Phase 1 study to determine safety, maximum tolerated dose (MTD), pharmacokinetic profile (PK) and efficacy in patients with solid tumours expressing EGFR or HER2.