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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3.5 years

Awards & highlights

Study Summary

This trial is studying a new drug for advanced cancer of stomach/oesophagus. It will check the drug's safety & effectiveness, and how well people tolerate it. Participants take the drug in tablet form & visit the study site regularly for tests & check-ups.

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.Check my eligibility

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.See study design

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

Select...

I am fully active or can carry out light work.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,512 Previous Clinical Trials

11,341,062 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers accepting new participants for this clinical examination?

"Clinicaltrials.gov shows that this trial, initially posted on October 18th 2023, is presently seeking participants. The details regarding the study were last altered on November 2nd 2023."

Answered by AI

How extensively has the safety of Phase Ia: Dose escalation been tested on patients?

"Our internal rating system at Power gave Part A (Phase Ia): Dose escalation a score of 1 since it is still in the Phase 1 trial, which indicates there is limited evidence regarding safety and efficacy."

Answered by AI

How many participants are engaging in this experiment?

"Affirmative. According to the information collated on clinicaltrials.gov, this medical trial is currently seeking patients who meet its requirements. It was first created on October 18th 2023 and last revised November 2nd 2023; it requires 146 individuals across a single site for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Test How Well Different Doses of BI 3706674 Are Tolerated by People With Advanced Cancer in the Stomach and Oesophagus

2023. "A Study to Test How Well Different Doses of BI 3706674 Are Tolerated by People With Advanced Cancer in the Stomach and Oesophagus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06056024.