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Ongoing Clinical Trials for Malignant Mast Cell Neoplasm

Currently, there are 6 ongoing clinical trials exploring new treatments for malignant mast cell neoplasm across multiple European countries. These studies investigate various investigational medications, including targeted therapies and immunotherapies, for patients with advanced or metastatic solid tumors. The trials are conducted in France, Spain, Italy, Germany, Belgium, Denmark, Netherlands, and Poland, offering opportunities for patients who have exhausted standard treatment options or are seeking new therapeutic approaches.

Clinical trial locations

Study on Alectinib for Children with ALK Fusion-Positive Solid or CNS Tumors After Ineffective Prior Treatment

This trial focuses on children under 18 years old with specific types of tumors that have a genetic change called ALK fusion-positive. The study is designed for young patients whose previous treatments did not work or who have no other good treatment options available.

Main inclusion criteria: Participants must be younger than 18 years old with confirmed ALK fusion-positive tumors in the brain or other parts of the body. They must have tried treatments that did not work or have no satisfactory alternatives. Patients need to have tumor tissue samples available and must be able to carry out daily activities at a reasonable level, measured using performance status scales appropriate for their age. Their organs must function well enough to handle the treatment.

Main exclusion criteria: Patients who have not shown disease progression after previous treatments or who have satisfactory treatment options cannot participate. Those not diagnosed with ALK fusion-positive tumors, outside the specified age range, unable to follow study procedures, with interfering medical conditions, pregnant or breastfeeding, or participating in other trials are excluded.

Trial focus: The study evaluates the safety and effectiveness of Alectinib, a medication taken orally as a capsule. Researchers aim to determine the best dose for children that matches the effective dose in adults without causing serious side effects. The trial monitors how the body processes the medication and how well it fights cancer in these young patients.

Investigational drug: Alectinib is designed to target and block the activity of the ALK gene, which may help treat these tumors. It is being studied to find the right pediatric dose and to evaluate its effectiveness in children with ALK fusion-positive tumors who have not responded to other treatments.

Study of BDC-1001 and Nivolumab for Patients with Advanced HER2-Positive Solid Tumors

This trial investigates treatments for patients with advanced solid tumors that express a protein called HER2 on their surface, which can make cancer grow more quickly. The study tests a new treatment called BDC-1001, both alone and combined with nivolumab.

Main inclusion criteria: Patients must have advanced solid tumors with HER2 expression for which no approved treatments are available, or they cannot tolerate or are not eligible for other treatments. They must be at least 18 years old, mentally competent to provide consent, and have adequate organ function including proper heart function. The disease must be measurable according to specific criteria, and patients must have a life expectancy of more than 12 weeks. Tumor tissue samples must be available for research.

Main exclusion criteria: Patients without advanced HER2-expressing solid tumors, outside the age range, unable to safely receive the treatment due to other health conditions, pregnant or breastfeeding, participating in another trial, recovering from recent major surgery, with severe allergies to similar treatments, active infections requiring treatment, or other cancers that might interfere with results are excluded.

Trial focus: The study aims to find out how safe and tolerable BDC-1001 is when used alone and in combination with nivolumab, which helps the immune system fight cancer. The trial is divided into phases: first testing BDC-1001 alone to determine the appropriate dose, then combining it with nivolumab to evaluate safety and effectiveness in shrinking tumors or stopping their growth.

Investigational drugs: BDC-1001 is an experimental medication being studied for treating advanced HER2-expressing solid tumors. Nivolumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells, tested in combination with BDC-1001 to potentially enhance treatment effectiveness.

Study of BMS-986449 and Nivolumab for Patients with Advanced Solid Tumors

This trial studies treatments for people with advanced solid tumors that have spread and are difficult to treat. The study involves BMS-986449, a new oral medication, and nivolumab, given through intravenous infusion.

Main inclusion criteria: Participants must be 18 years or older with confirmed diagnosis of locally advanced, unresectable, metastatic, or recurrent solid tumors. For certain study parts, specific cancer types are required: any solid cancer for Part 1A, non-small cell lung cancer for Part 1B, and triple-negative breast cancer for Part 1C. Patients must have tried existing treatments that did not work or are unable to receive them. The disease must be measurable according to specific guidelines, and a tumor biopsy must be obtained unless medically impossible.

Main exclusion criteria: Patients with cancer types different from those being studied, outside the required age range, unable to follow study procedures or take medication as required, pregnant or breastfeeding, with serious health conditions that could interfere, taking certain interfering medications, having had recent surgery, participating in another recent trial, with allergies to similar medications, or with substance abuse history are excluded.

Trial focus: The study aims to understand the safety and tolerability of BMS-986449 when used alone or with nivolumab. Some participants may receive a placebo for comparison. Regular monitoring will assess how the body responds and any side effects that occur.

Investigational drugs: BMS-986449 is an experimental oral medication being studied for safety and tolerability in advanced solid tumors. Nivolumab is an immune checkpoint inhibitor combined with BMS-986449 to potentially enhance effectiveness in treating advanced solid tumors.

Study of Entrectinib in Children and Adolescents with Advanced or Metastatic Solid Tumors or Primary CNS Tumors with No Satisfactory Treatment Options

This trial studies the medication entrectinib (brand name Rozlytrek) in children and adolescents with advanced or spreading solid tumors or primary tumors in the central nervous system. The study specifically targets young patients with no satisfactory treatment options.

Main inclusion criteria: Participants must be under 18 years old with measurable or evaluable disease. The tumors must have specific gene fusions called NTRK1/2/3 or ROS1. Patients must have been diagnosed with cancer initially or if it has returned. If tumor testing was done locally, tissue samples must be sent for further specialized testing. Participants need a performance status score of at least 60% and minimum life expectancy of 4 weeks.

Main exclusion criteria: Patients who have not fully recovered from previous treatment side effects, with serious interfering health conditions, currently in another trial, having had recent major surgery, with uncontrolled infections, pregnant or breastfeeding, with allergies to the study medication, unstable heart conditions, unmanaged mental health conditions, or unable to follow study procedures are excluded.

Trial focus: The study determines the best dose of entrectinib for children and evaluates its effectiveness in treating tumors with specific genetic changes. The trial assesses how the body processes the medication, monitors side effects, and measures tumor response using specific criteria. The medication comes in different forms including capsules or granules that can be swallowed or given through a feeding tube.

Investigational drug: Entrectinib (RXDX-101) is being studied for pediatric patients with locally advanced or metastatic solid or CNS tumors, particularly those with NTRK1/2/3 or ROS1 gene fusions. The trial aims to find the most effective and safe dose for children and evaluates how well it shrinks tumors with these specific genetic changes.

Study on the Safety and Effects of BNT314 Alone or with Pembrolizumab for Patients with Advanced Solid Tumors

This trial studies the safety and initial effectiveness of BNT314 for patients with advanced malignant solid tumors that have spread and are not easily removable by surgery. The medication is tested alone and in combination with pembrolizumab (Keytruda).

Main inclusion criteria: Patients must be 18 years or older and able to provide informed consent. They need adequate kidney function (GFR 45 or higher) and pancreas function with no signs of inflammation. Patients who can have children must have negative pregnancy tests and agree to use highly effective contraception during the trial and for 60 days (women) or 90 days (men) after treatment. For different study parts, patients need confirmed advanced malignant solid tumors with disease progression after standard therapy or inability to tolerate standard treatment. The disease must be measurable according to specific guidelines, with life expectancy over 3 months and good performance status. Adequate blood clotting, bone marrow, and liver function are required.

Main exclusion criteria: Patients with different cancer types than studied, outside the age range, unable to follow procedures, with interfering medical conditions, pregnant or breastfeeding, recently in another trial, with allergies to study medication, certain infections, taking interfering medications, or with substance abuse history are excluded.

Trial focus: The study begins with dose escalation to find the maximum safe amount of BNT314, then moves to dose expansion to gather more information about safety and effectiveness. BNT314 is given through intravenous infusion, sometimes combined with pembrolizumab. Patients are closely monitored for side effects and cancer response throughout the trial, expected to continue until 2027.

Investigational drugs: BNT314 is a new medication being tested for the first time in humans to determine safety and best dose for advanced solid tumors. Pembrolizumab is an immune checkpoint inhibitor that helps the immune system fight cancer, used in combination with BNT314 to potentially enhance treatment effectiveness.

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

This trial studies two investigational medications, Livmoniplimab and Budigalimab, for treating solid tumors. The study evaluates safety, tolerability, and how the body processes these medications, aiming to find the best dose when used alone and in combination.

Main inclusion criteria: Patients must have solid tumors that are locally advanced or metastatic. For the dose escalation phase, patients should have advanced tumors not responding to or unable to tolerate existing treatments, or refuse/are ineligible for standard treatments. Patients need an ECOG Performance Status of 0 to 1, meaning fully active or with symptoms but able to carry out light work. For dose expansion, disease must be measurable according to specific criteria. Patients with certain cancer types (MSS-CRC, HCC, pancreatic adenocarcinoma) must not have had previous treatment with PD-1/PDL-1 antagonists. Adequate bone marrow, kidney, liver, and blood clotting function is required. Additional criteria apply based on specific cancer types for both phases.

Main exclusion criteria: The trial excludes patients with cancer types different from those studied, outside specified age ranges, unable to follow procedures, with interfering medical conditions, pregnant or breastfeeding, in another trial, with allergies to study medications, certain infections, taking interfering medications, or unable to follow instructions.

Trial focus: The study is divided into dose escalation and dose expansion phases. Participants receive medications through intravenous infusion. The trial monitors for side effects and measures how the medications affect tumors, including response duration and progression-free survival. Both phases focus on determining appropriate dosage and evaluating effectiveness in specific tumor types.

Investigational drugs: ABBV-151 (Livmoniplimab) is an experimental medication being tested for safety and tolerability in advanced or spreading solid tumors, used to find the best dose alone and with budigalimab. Budigalimab is tested in combination with ABBV-151 to see if the combination can treat certain tumors more effectively than single-agent treatment.

Summary

The six ongoing clinical trials for malignant mast cell neoplasm represent a diverse range of therapeutic approaches across Europe. France appears as the most active location with participation in five trials, followed by Spain and Italy with five and four trials respectively. Germany and Belgium each host three trials, while Denmark, Netherlands, and Poland participate in fewer studies.

Several notable patterns emerge from these trials. Two studies specifically target pediatric populations, investigating alectinib and entrectinib in children and adolescents with specific genetic alterations (ALK fusion-positive and NTRK1/2/3 or ROS1 gene fusions). The remaining four trials focus on adult patients with advanced or metastatic solid tumors.

Immunotherapy combinations feature prominently, with three trials evaluating immune checkpoint inhibitors (nivolumab, pembrolizumab, or budigalimab) in combination with investigational agents. These studies reflect the current trend toward combination approaches in cancer treatment. The trials generally target patients who have exhausted standard treatment options or cannot tolerate conventional therapies, addressing an important unmet medical need.

The investigational drugs span different mechanisms of action, from targeted therapies blocking specific proteins (alectinib, entrectinib) to immunotherapies enhancing immune response (BDC-1001, BMS-986449, BNT314, and combination approaches). Most trials are in early phases, focusing on establishing safety profiles, determining optimal dosing, and gathering preliminary effectiveness data before potential advancement to larger confirmatory studies.

Ongoing Clinical Trials on Malignant mast cell neoplasm

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