What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors that block growth signals, similar to BI 3706674, include gastrointestinal issues like diarrhea and nausea, skin reactions such as rash and erythema, fatigue, and potential liver toxicity. Hematologic toxicities, including neutropenia and anemia, are also observed. These side effects are carefully monitored to manage their impact on patients.

What prior FDA approvals exist?

Several drugs that block growth signals to prevent tumor growth have been approved by the FDA for the treatment of solid tumors. For instance, cabozantinib (XL184) is an oral tyrosine kinase inhibitor approved for medullary thyroid cancer, which works by inhibiting multiple tyrosine kinases involved in tumor growth and angiogenesis. Pembrolizumab, an anti-PD-1 therapy, has been approved for various solid tumors, including melanoma and non-small cell lung cancer, by blocking the PD-1 pathway to enhance the immune system's ability to fight cancer. These treatments share a mechanism of action similar to BI 3706674, which is being studied for its potential to block growth signals and prevent tumor growth in advanced stomach and oesophagus cancer.

What other types of research exist?

Promising novel alternatives to BI 3706674 for solid tumor patients include: 1) Cabozantinib (XL184), a tyrosine kinase inhibitor that has shown activity in medullary thyroid cancer and other solid tumors. 2) Pembrolizumab, an immune checkpoint inhibitor that has demonstrated efficacy in non-small cell lung cancer and other solid tumors. 3) SR18662, a small molecule that has shown significant growth inhibition in colorectal cancer models. 4) BI 2536, a Polo-like kinase-1 inhibitor that induces mitotic arrest and apoptosis in neoplastic mast cells and may have potential in other solid tumors.

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Monoclonal Antibodies

BI 3706674 for Stomach and Esophageal 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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Be older than 18 years old

Must not have

Previous treatment with rat sarcoma (RAS), mitogen-activated protein kinases (MAPKs) or son of sevenless homolog 1 (SOS1) targeting agents.

Presence of cardiovascular abnormalities such as uncontrolled hypertension (defined as systolic blood pressure ≥140 and/or diastolic blood pressure ≥90 millimetre of mercury (mmHg)), congestive heart failure New York Heart Association (NYHA) classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia. History of myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomisation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for adults with advanced stomach or oesophagus cancer who have no other treatment options. It tests a new drug, BI 3706674, taken as a tablet, to find an appropriate amount and see if it can shrink tumors by blocking their growth signals. Participants will have periodic health monitoring to track their health and any side effects.

Who is the study for?

Adults with advanced stomach or oesophagus cancer who have not had success with previous treatments, or for whom no other treatment options are available. They must have a specific type of genetic feature in their cancer cells (KRAS wild type amplification) and be able to undergo certain biopsies if needed. Participants should be generally healthy otherwise, with a life expectancy of at least 3 months.

What is being tested?

The trial is testing different doses of BI 3706674, an experimental drug taken as a tablet that may block tumor growth by interfering with growth signals. The goal is to determine the highest dose patients can tolerate without severe side effects and to see if it can shrink tumors.

What are the potential side effects?

Since this is the first time BI 3706674 is given to humans, potential side effects are being investigated. However, participants might experience typical drug-related reactions such as nausea, fatigue, allergic responses or more serious complications depending on how they react to the medication.

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 can carry out light work.

Exclusion Criteria

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

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I have been treated with drugs targeting RAS, MAPKs, or SOS1.

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I do not have severe heart issues or recent major heart or blood clot events.

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I or my family have a history of long QT syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3.5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period

Part B: Occurrence of drug-related adverse events (AEs) ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 during the on-treatment period

Part C: Objective response (OR) based on central assessment

Secondary study objectives

All trial parts: Area under the plasma concentration-time curve over a uniform dosing interval τ (AUCτ) of BI 3706674 evaluated after the first dose in Cycle 1

All trial parts: Area under the plasma concentration-time curve over a uniform dosing interval τ of BI 3706674 evaluated at steady state on Cycle 2 Day 1 (AUCτ,ss)

All trial parts: Maximum measured concentration (Cmax) of BI 3706674 evaluated after the first dose in Cycle 1

+11 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part C (Phase Ib): Dose expansionExperimental Treatment1 Intervention

Group II: Part B (Phase Ib): Dose confirmationExperimental Treatment1 Intervention

Group III: Part A (Phase Ia): Dose escalationExperimental Treatment1 Intervention

0 / 4Eligibility 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

Common treatments for solid tumors often focus on blocking growth signals that tumors use to proliferate. For example, BI 3706674, which is being studied for advanced stomach and esophageal cancers, works by inhibiting specific pathways that promote tumor growth. This mechanism is crucial as it can lead to tumor shrinkage and potentially improve patient outcomes. Other treatments include chemotherapy, which kills rapidly dividing cells; immunotherapy, which boosts the body's immune response against cancer cells; and targeted therapy, which specifically attacks cancer cells with minimal damage to normal cells. These approaches are vital for managing solid tumors, offering hope for better control and improved survival rates.

[Molecular (de)regulation and cancer: new therapeutic strategies].