A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Boehringer Ingelheim
Study ID
NCT05471856
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BI 1703880 — DRUG
    BI 1703880
  • Ezabenlimab — DRUG
    Ezabenlimab

Study Details

This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists. The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab. BI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time. Participants get BI 1703880 and ezabenlimab as infusions into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks. Participants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants' health and take note of any unwanted effects.

Key Dates

Start date
Feb 24, 2023
Status verified
Dec 2025
Primary completion
Sep 13, 2028
Completion
Sep 13, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards)

Primary Outcome Measure

Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period [ Time Frame: up to 6 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Valkyrie Clinical TrialsLos AngelesCalifornia90067
Boehringer Ingelheim
[email protected]
833-602-2368
Yale University School of MedicineNew HavenConnecticut06511
Boehringer Ingelheim
[email protected]
833-602-2368
John Theurer Cancer CenterHackensackNew Jersey07601
Boehringer Ingelheim
[email protected]
833-602-2368

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By research site
Valkyrie Clinical Trials· Los Angeles, CAYale University School of Medicine· New Haven, CTJohn Theurer Cancer Center· Hackensack, NJ

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