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NCT05471856 · Boehringer Ingelheim

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)

What this study is about

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.

View original scientific description

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.

Interventions

DRUG

BI 1703880

BI 1703880

DRUG

Ezabenlimab

Ezabenlimab

Primary outcome measures

Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period

Time frame: up to 6 weeks

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic or relapsed/refractory solid tumour. Patient must have at least one measurable lesion (according to Response Criteria in Solid Tumours (RECIST 1.1)).
  • Patient must have exhausted or refused established treatment options for the malignant disease, or is not eligible for established treatment options.
  • Has a lesion amenable to pre-treatment and on-treatment biopsy and patient consents to both biopsies.
  • Medically fit and willing to undergo all mandatory trial procedures.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Adequate organ function or bone marrow reserve as demonstrated at screening by the following laboratory values:
  • Absolute neutrophil count ≥ 1.5x10\^9/L (≥ 1.5x10\^3/μL, ≥ 1500/mm3); platelet count ≥ 100x10\^9/L (≥ 100x10\^3/μL, ≥ 100x10\^3/mm3), without the use of hematopoietic growth factors within 4 weeks of start of trial medication
  • Haemoglobin ≥ 90 g/L (≥ 9.0 g/dL, ≥ 5.6 mmol/L)
  • Estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73m\^2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.
  • Total bilirubin ≤ 1.5 x ULN, except for patients with Gilbert's syndrome: total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
  • partial thromboplastin time (PTT) / activated partial thromboplastin time (aPTT) \<1.5 x ULN
  • Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF).
  • Signed and dated written ICF in accordance with International Council for Harmonisation- Good Clinical Practice (ICH-GCP) and local legislation, obtained before performing any protocol related procedures that are not part of normal standard of practice care. Note: If a patient declines to participate in the voluntary biobanking component of the trial, he/she will not be excluded from other aspects of the trial. Further inclusion criteria apply

Exclusion criteria

  • Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter.
  • Prior STING agonist therapy.
  • Prior intolerability of a anti-programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) therapy.
  • History of allergy or hypersensitivity to study agent components.
  • Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding \>10 mg/day of prednisone or equivalent, and tumour necrosis factor-alpha blockers.
  • Persistent toxicity from previous treatments (including immune related Adverse Events (irAEs)) that has not resolved to Grade ≤1, except for alopecia, xerostomia, and immunotherapy related endocrinopathies.
  • Evidence of active, non-treatment related autoimmune disease, except for endocrinopathies.
  • History or complication of pneumonitis or interstitial lung disease within the last 12 months, or any prior pneumonitis related to immunotherapy. Further exclusion criteria apply

Where

  • Los Angeles, California
  • New Haven, Connecticut
  • Hackensack, New Jersey

Related conditions & keywords

Solid Tumors

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Dec 17, 2025 · Source of record for eligibility and locations

📊
1 of 66 participants interested
2% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Los Angeles

California

Location available
RECRUITING

New Haven

Connecticut

Location available
RECRUITING

Hackensack

New Jersey

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Advanced Solid Tumors Trials by City

Browse all advanced solid tumors clinical trials in these cities — not just this study.

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Looking for Solid Tumors Treatment in Los Angeles?

Join others in California exploring innovative treatment options through clinical research

Solid Tumors Treatment Options in Los Angeles, California

If you're searching for Solid Tumors treatment in Los Angeles, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Los Angeles, New Haven, Hackensack and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Solid Tumors. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 66 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Solid Tumors?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Solid Tumors

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Solid Tumors Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05471856. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.