What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) targeting HER2 gene mutations, such as BI 1810631, gefitinib, fam-trastuzumab deruxtecan, and ado-trastuzumab emtansine, have a range of side effects. BI 1810631, being a new investigational drug, has its side effects closely monitored, including potential gastrointestinal and hematologic toxicities. Gefitinib is associated with skin rashes and diarrhea, mostly grades 1 or 2. Fam-trastuzumab deruxtecan can cause decreased neutrophil count, anemia, nausea, and interstitial lung disease. Ado-trastuzumab emtansine's side effects include fatigue, nausea, and potential liver toxicity. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

For the treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 gene mutations, the FDA has approved several targeted therapies. Fam-trastuzumab deruxtecan has shown efficacy with a median progression-free survival (PFS) of 8.2 months and an overall response rate (ORR) of 55%. Ado-trastuzumab emtansine has also been effective, with an ORR of 44% and a median PFS of five months. Additionally, trastuzumab-based regimens and small-molecule tyrosine kinase inhibitors (TKIs) like poziotinib, pyrotinib, and TAK-788 (mobocertinib) have demonstrated efficacy in clinical trials for HER2-mutant NSCLC.

What other types of research exist?

Promising alternatives to BI 1810631 for NSCLC patients with HER2 mutations include afatinib, which has shown efficacy in patients with HER2 exon 20 insertions and specific mutations like HER2 S310Y. Another option is trastuzumab-based therapies, which have been effective in patients with HER2 mutations, such as the exon 20 G776VinsC mutation. Additionally, poziotinib, a pan-HER tyrosine kinase inhibitor, has been associated with sensitivity in HER2-mutated NSCLC.

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Small Molecule Inhibitor

BI 1810631 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must show presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

Eastern Cooperative Oncology Group score of 0 or 1.

Must not have

Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening

-- effectively treated non-melanoma skin cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of the trial treatment until end of month 12, up to 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called BI 1810631, which is taken as tablets. It targets adults with advanced cancers that have specific genetic changes and have not responded to other treatments. The goal is to find a safe dose and see if it can help shrink tumors.

Who is the study for?

Adults with advanced cancers showing changes in the HER2 gene, who have not responded to previous treatments, can join this trial. They must be generally healthy, able to take tablets daily or twice a day, and willing to use effective birth control. People with certain blood counts and organ functions are eligible. Those with brain metastases that don't need immediate treatment may also qualify.

What is being tested?

The trial is testing BI 1810631's tolerable doses on various advanced cancers (Part 1) and its effectiveness in shrinking tumors in non-small cell lung cancer patients with specific HER2 mutations (Part 2). Participants will receive BI 1810631 orally as part of their ongoing treatment regimen while being monitored for health and tumor response.

What are the potential side effects?

Since BI 1810631 is new and given for the first time to people in this study, potential side effects are closely monitored but could include typical reactions related to cancer medications such as nausea, fatigue, allergic reactions or other unforeseen issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced, can't be surgically removed, and has at least one measurable tumor.

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I am fully active or can carry out light work.

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I am willing and able to follow the study's requirements for tumor biopsies, excluding those from the brain.

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My organs are functioning well.

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I am at least 18 years old or the legal age in my country.

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I am using or willing to use effective birth control.

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I have tried all known treatments for my condition without success, or I cannot undergo these treatments.

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My lung cancer is non-squamous NSCLC with a HER2 mutation.

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My non-squamous NSCLC has a HER2 mutation in the TKD.

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I have not received any treatment for my non-squamous NSCLC.

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My NSCLC has a HER2 mutation outside the TKD or is squamous with a TKD mutation.

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My NSCLC has a HER2 mutation according to tests.

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My non-squamous NSCLC has a HER2 mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had major surgery in the last 4 weeks and don't plan any in the next 6 months.

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My skin cancer, not melanoma, has been treated successfully.

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I have been successfully treated for early-stage cervical cancer.

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My ductal carcinoma in situ has been treated successfully.

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I haven't taken any cancer drugs or experimental drugs in the last 21 days or 5 half-lives, whichever is shorter.

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I need to keep taking certain medications that may affect the trial.

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I am not taking strong CYP3A4 inhibitors.

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I am not taking medication that strongly affects liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of the trial treatment until end of month 12, up to 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of the trial treatment until end of month 12, up to 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the trial treatment until end of month 12, up to 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase Ia: Maximum Tolerated Dose (MTD)

Phase Ia: Number of patients with Dose Limiting Toxicities (DLTs) in the MTD evaluation period

Phase Ib - Cohort 3: Objective response according to RECIST 1.1 by investigator assessment

+2 more

Secondary study objectives

Phase Ia: Area under the concentration-time curve of BI 1810631 in plasma (AUC0-t2)

Phase Ia: Maximum measured concentration of BI 1810631 in plasma (Cmax)

Therapeutic procedure

+21 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Phase Ib - Dose expansion part: Cohort 5Experimental Treatment1 Intervention

Group II: Phase Ib - Dose expansion part: Cohort 4Experimental Treatment1 Intervention

Group III: Phase Ib - Dose expansion part: Cohort 3Experimental Treatment1 Intervention

Group IV: Phase Ib - Dose expansion part: Cohort 2Experimental Treatment1 Intervention

Group V: Phase Ib - Dose expansion part: Cohort 1Experimental Treatment1 Intervention

Group VI: Phase Ia - Dose escalation partExperimental Treatment1 Intervention

Consecutive cohorts of patients treated with escalating doses of BI 1810631 monotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 1810631

2023

Completed Phase 1

~70

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

HER2-targeted therapies for Non-Small Cell Lung Cancer (NSCLC) with HER2 gene mutations work by specifically targeting the HER2 protein, which is overexpressed in some cancer cells. Trastuzumab is a monoclonal antibody that binds to the HER2 receptor, inhibiting cell proliferation and promoting immune-mediated destruction of the cancer cells. Fam-trastuzumab deruxtecan and ado-trastuzumab emtansine are antibody-drug conjugates that deliver cytotoxic agents directly to HER2-expressing cells, enhancing the anti-tumor effect while minimizing damage to normal cells. These treatments are crucial for NSCLC patients with HER2 mutations as they offer a targeted approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Randomized phase II study of weekly docetaxel plus trastuzumab versus weekly paclitaxel plus trastuzumab in patients with previously untreated advanced nonsmall cell lung carcinoma.