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Study on the Safety and Effects of Livmoniplimab and Budigalimab in Patients with Advanced or Metastatic Solid Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for solid tumors, which are abnormal masses of tissue that can occur in various parts of the body. The study involves two investigational medications: Livmoniplimab and Budigalimab. These medications are being tested to see how safe and tolerable they are for patients, as well as how the body processes them. The trial aims to find the best dose of Livmoniplimab when used alone and in combination with Budigalimab.

The study is divided into two phases. In the first phase, participants will receive increasing doses of Livmoniplimab to determine the most suitable dose. In the second phase, the focus will be on evaluating the effectiveness of the combination of Livmoniplimab and Budigalimab in treating specific types of solid tumors. Participants will receive the medications through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein.

The trial will monitor participants for any side effects and measure how the medications affect their tumors. The study will also look at how long the response to the treatment lasts and how long participants live without their disease getting worse. This research is important for understanding how these new treatments might help people with advanced solid tumors in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation begins in a clinical trial designed to evaluate the safety and effectiveness of two medications, livmoniplimab and budigalimab, for treating advanced solid tumors.

    The trial is divided into two phases: the dose escalation phase and the dose expansion phase.

  2. Step 2

    Dose escalation phase

    During this phase, the focus is on determining the appropriate dosage of ABBV-151 when used alone and in combination with budigalimab.

    The medication is administered intravenously as a solution for infusion. The specific dosage and frequency will be adjusted based on individual response and tolerance.

  3. Step 3

    Dose expansion phase

    In this phase, the effectiveness of the medication combination is assessed in specific types of tumors.

    The goal is to evaluate the response rate of the treatment using criteria that measure tumor size and progression.

  4. Step 4

    Medication administration

    The medications, livmoniplimab and budigalimab, are administered intravenously. The form of administration is a solution for infusion, which means the medication is delivered directly into the bloodstream through a vein.

    The frequency and duration of administration will depend on the phase of the trial and individual response.

  5. Step 5

    Monitoring and assessments

    Throughout the trial, regular assessments are conducted to monitor health and response to the treatment. This includes checking vital signs, conducting laboratory tests, and performing electrocardiograms (ECGs).

    The occurrence of any side effects or adverse reactions is closely monitored to ensure safety.

  6. Step 6

    End of trial

    The trial is expected to conclude by January 1, 2025. At the end of the trial, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.

Who can join the trial?

16 criteria

  • Patients must have **solid tumors** that are either **locally advanced** (spread to nearby areas) or **metastatic** (spread to other parts of the body).
  • For the **Dose Escalation** phase, patients should have an advanced solid tumor that does not respond to or cannot tolerate existing treatments. Patients who refuse standard treatments or are not eligible for them may also be considered.
  • Patients must have an **ECOG Performance Status** of 0 to 1, which means they are fully active or have some symptoms but can carry out light work.
  • For the **Dose Expansion** phase, patients must have a measurable disease according to specific criteria used to evaluate tumors.
  • Patients with certain types of cancer, like **MSS-CRC**, **HCC**, or **pancreatic adenocarcinoma**, must not have had previous treatment with specific immune therapies known as **PD-1/PDL-1 antagonists**.
  • Patients must have adequate function of their **bone marrow**, **kidneys**, **liver**, and **blood clotting** systems.
  • For the **Dose Escalation** phase, patients with specific cancers like **pancreatic adenocarcinoma**, **urothelial cancer**, **HCC**, or **HNSCC** must meet additional criteria related to their cancer type.
  • For the **Dose Expansion** phase, patients with **pancreatic adenocarcinoma** must have had disease progression during or after one systemic therapy.
  • For the **Dose Expansion** phase, patients with **urothelial cancer** must have progressed after treatment with a platinum-based regimen and a PD1/PDL1 antagonist.
  • For the **Dose Expansion** phase, patients with **HCC** must have had disease progression during or after one prior line of systemic therapy.
  • For the **Dose Expansion** phase, patients with **HNSCC** must have progressed after treatment with a platinum-based regimen and a PD1/PDL1 antagonist.
  • For the **Dose Expansion** phase, patients with **MSS-CRC** must have received prior chemotherapy regimens including specific drugs like **oxaliplatin** and **irinotecan**.
  • Patients with **NSCLC** must have received one prior line of chemotherapy and one prior anti-PD(L)1 antibody treatment. They should not have progressed on more than one line of chemotherapy in the metastatic setting.
  • Patients must be within certain age ranges, typically adults.
  • Both male and female patients are eligible to participate.
  • Patients from vulnerable populations may be included in the study.
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Investigated drugs

  • ABBV-151

    is an experimental medication being tested to see how safe and tolerable it is for people with advanced or spreading solid tumors. Researchers are trying to find the best dose to use when given alone or with another medication.

  • Budigalimab

    is a medication being tested in combination with ABBV-151. The goal is to see if using these two medications together can help treat certain types of tumors more effectively.

What is already known about the treatment

  • ABBV-151

    ABBV-151 is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating locally advanced or metastatic solid tumors. It is in the early stages of research, specifically in a Phase 1 trial, to determine the appropriate dosage and potential benefits. The main therapeutic indication is for solid tumors, particularly those that are locally advanced or metastatic. At the molecular level, ABBV-151 works by targeting specific pathways involved in tumor growth, although the exact mechanism is still under investigation. It is classified as an investigational drug, meaning it is not yet approved for general medical use.

  • Budigalimab

    Budigalimab is also administered intravenously and is being evaluated in combination with ABBV-151 for its potential to treat solid tumors. It is part of the same clinical trial, focusing on its role in enhancing the effects of ABBV-151. The main therapeutic indication is for solid tumors, especially those that are locally advanced or metastatic. Budigalimab functions by modulating the immune system to better recognize and attack cancer cells. It is classified as a monoclonal antibody, a type of protein designed to target specific antigens on cancer cells.

Investigated diseases

  • Solid Tumors

    Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they grow, they may press on surrounding tissues and organs, potentially affecting their function. Solid tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they can invade nearby tissues and spread to distant sites. The progression of solid tumors depends on their type, location, and whether they are benign or malignant.

  • Locally Advanced or Metastatic Solid Tumors

    Locally advanced solid tumors are those that have grown significantly and may have spread to nearby tissues or lymph nodes but not to distant parts of the body. Metastatic solid tumors have spread from their original site to other parts of the body, forming new tumors in distant organs or tissues. These tumors can cause symptoms depending on their location and the extent of their spread. The progression of locally advanced tumors may involve further local growth and potential invasion into nearby structures. Metastatic tumors can continue to spread to additional sites, complicating the condition. The behavior and impact of these tumors vary based on their origin and the organs involved.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508281-15-00Protocol codeM19-345Estimated enrolment330 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).