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Checkpoint Inhibitor

BI 770371 + Ezabenlimab for Advanced Solid Tumors

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) Score: 0 to 1
Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type)
Must not have
Major surgery (major according to the Investigator's assessment) performed within 12 weeks prior to randomisation or planned within 12 months after screening, e.g. hip replacement
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is for adults with advanced cancer who have no other treatment options. The purpose is to find the highest dose of BI 770371 that people can tolerate when taken alone or with ezabenlimab.

Who is the study for?
Adults with advanced solid tumors who have not had success with previous treatments or have no other treatment options can join this study. They must be over 18, able to consent, and have a life expectancy of at least 3 months. Participants should not have active brain metastases or severe allergies to trial drugs.Check my eligibility
What is being tested?
The trial is testing the highest tolerable dose of BI 770371 alone or combined with ezabenlimab in adults with advanced cancer. Both are antibodies that may boost the immune system's ability to fight cancer. Treatments are given as infusions every three weeks for up to two years if beneficial.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (immune-related adverse events), infusion reactions, fatigue, and potentially others not listed here due to these being new treatments.

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 restricted in physically strenuous activity but can do light work.
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I have an advanced cancer that cannot be removed by surgery.
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I have tried all known treatments for my condition without success.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had, nor plan to have, any major surgeries like a hip replacement around the trial period.
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I need to keep taking certain medications that may affect the trial's safety.
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I have had lung inflammation or interstitial lung disease in the past 5 years.
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I've had severe allergic reactions to other antibody treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in combination therapy
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in monotherapy
Secondary outcome measures
Occurrence of Adverse Events (AEs) during the on-treatment period in combination therapy
Occurrence of Adverse Events (AEs) during the on-treatment period in monotherapy
Occurrence of Dose Limiting Toxicities (DLTs) during the on-treatment period in combination therapy
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Monotherapy dose escalationExperimental Treatment1 Intervention
Group II: Combination therapy dose escalationExperimental Treatment2 Interventions

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
Checkpoint inhibitors, such as BI 770371 and Ezabenlimab, are a form of immunotherapy that enhance the immune system's ability to fight cancer by blocking proteins that inhibit immune responses. These drugs target checkpoints like PD-1/PD-L1 or CTLA-4, allowing T-cells to attack and destroy cancer cells more effectively. This mechanism is crucial for patients with solid tumors, as it provides a promising treatment option, particularly for those who have not responded to conventional therapies.
Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.The challenge of targeted therapies for gastric cancer patients: the beginning of a long journey.Cetuximab in non-small-cell lung cancer.

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,516 Previous Clinical Trials
11,347,304 Total Patients Enrolled

Media Library

BI 770371 (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05327946 — Phase 1
Solid Tumors Research Study Groups: Monotherapy dose escalation, Combination therapy dose escalation
Solid Tumors Clinical Trial 2023: BI 770371 Highlights & Side Effects. Trial Name: NCT05327946 — Phase 1
BI 770371 (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327946 — Phase 1
~9 spots leftby Mar 2025