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 study about?

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.

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 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 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 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 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 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 Study?

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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Centre Jean Perrin	Clermont Ferrand	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Cyppdshpt Uchkydkhypswgg Stvcnwaqb	Woluwe-Saint-Lambert	Belgium
Chnbnn Lgyy Bdavzu	Lyon	France
Novlxdzy Ihqavsoe Ovpvpmezg Ipb Mpmos Srmwyjygvvgltovssccjbqhhxrvp Iibjbqne Bbnozzbh	Cracow	Poland
Kwlvnslz Ewviirfaqqlnruvdrgodcvuu Hucttpgstcgrourez	Essen	Germany
Hrgnowju Vscx dyysvvos	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	24.12.2020
France	Not recruiting	24.12.2020
Germany	Not recruiting	24.12.2020
Italy	Not recruiting	24.12.2020
Poland	Not recruiting	24.12.2020
Spain	Not recruiting	24.12.2020

Trial locations

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.

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 ID:

2023-508281-15-00

Protocol code:

M19-345

NCT ID:

NCT03821935

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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

What is this study about?

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