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Monoclonal Antibodies

BI 764532 for Small Cell Lung 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

Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin

Patient has failed or is not eligible for available standard therapies according to local guidelines. Standard therapies should include at least one line of chemotherapy that should include platinum for patients with small cells carcinoma tumors histologies.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

Study Summary

This trial is exploring a new drug, BI 764532, to determine the maximum tolerated dose and the recommended dose for expansion. The goal is to also document the drug's safety and efficacy.

Who is the study for?

Adults with advanced small cell lung cancer or neuroendocrine tumors positive for DLL3, who have not had success with previous treatments or lack standard treatment options. Participants must be in good physical condition (ECOG 0-1), have at least one measurable tumor outside the brain, and their major organs must function well. Pregnant women, those on certain medications, or with other active cancers are excluded.Check my eligibility

What is being tested?

The trial is testing BI 764532, a new antibody-like molecule designed to help the immune system fight cancer. It's given either weekly or every three weeks for up to three years if tolerated and beneficial. The goal is to determine the highest tolerable dose and best treatment schedule.See study design

What are the potential side effects?

Since BI 764532 is being tested for the first time in humans, specific side effects are unknown but may include typical reactions related to immune therapies such as inflammation in various organs, infusion-related reactions, fatigue, potential blood disorders and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a type of neuroendocrine or small cell carcinoma.

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I can't use standard cancer treatments or they didn't work for me.

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I am fully active or can carry out light work.

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I have a measurable cancer lesion outside of my brain.

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My cancer is advanced or has spread and cannot be cured with surgery or radiation.

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My tumor is positive for DLL3.

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My tumor is mostly made up of neuroendocrine/small tumor cells.

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I cannot use or have not responded to standard treatments.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Arm 1 and Arm 2: Maximum tolerated dose (MTD)

Arm 1 and Arm 2: Number of patients with DLTs in the MTD evaluation period

Secondary outcome measures

Arm 1 and Arm 2: Area under the concentration-time curve (AUCτ) of the analyte over a uniform dosing interval τ

Arm 1 and Arm 2: Maximum measured concentration (Cmax) of BI 764532

Arm 1 and Arm 2: Objective response based on RECIST 1.1 criteria in patients with measurable disease

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: BI 764532Experimental Treatment1 Intervention

Group II: Arm 1: BI 764532Experimental Treatment1 Intervention

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,622 Total Patients Enrolled

8 Trials studying Small Cell Lung Carcinoma

12,816 Patients Enrolled for Small Cell Lung Carcinoma

Media Library

BI 764532 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04429087 — Phase 1

Small Cell Lung Carcinoma Research Study Groups: Arm 2: BI 764532, Arm 1: BI 764532

Small Cell Lung Carcinoma Clinical Trial 2023: BI 764532 Highlights & Side Effects. Trial Name: NCT04429087 — Phase 1

BI 764532 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04429087 — Phase 1

Frequently Asked Questions

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

Is BI 764532 authorized by the FDA?

"There is limited clinical data available to support the safety and efficacy of BI 764532, thus it has been assigned a score of 1."

Answered by AI

What is the approximate number of participants taking part in this research project?

"That is correct. According to the information present on clinicaltrials.gov, this trial has been recruiting since July 15th 2020 and was recently updated November 14th 2022. This medical investigation requires 110 participants from 2 separate sites to be recruited in total."

Answered by AI

Are there any enrolment opportunities for this medical experiment?

"Affirmative. Clinicaltrials.gov's information confirms that this research study is presently enrolling participants, having been first posted on July 15th 2020 and most recently updated November 14th 2022. This medical trial needs 110 individuals from two separate locations to participate."

Answered by AI