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Vimseltinib

Clinical trials are investigating Vimseltinib in people with tenosynovial giant cell tumor and in patients with advanced tumors. These studies look at safety, how well the treatment works, and other research measures such as dose selection and drug levels in the body.

Table of Contents

Clinical trial overview

The trial data show two interventional studies of Vimseltinib.[1][2] Both studies are authorised and focus on patients with tenosynovial giant cell tumor, and one study also includes patients with advanced tumors.[1][2]

These studies are designed to learn different things, such as safety, tumor response, dose selection, and drug levels in the body.[2]

Phase 3 study in tenosynovial giant cell tumor

NCT05059262 is a multicenter, randomized, Phase 3 study in patients with tenosynovial giant cell tumor.[1] It has 2 parts: Part 1 is double blinded, and Part 2 is open label.[1]

In this study, the main question is whether Vimseltinib has anti-tumor activity compared with placebo.[1] The study summary says the tumor response is being checked by blinded independent radiological review using RECIST v1.1.[1]

The primary endpoint is objective response rate (ORR) at Week 25, which includes complete response and partial response.[1] This means the study measures how many patients have meaningful tumor shrinkage by that time point.[1]

Phase 1/2 study in advanced tumors and TGCT

NCT03069469 is a multicenter, open-label Phase 1/2 study in patients with advanced tumors and tenosynovial giant cell tumor.[2] The study is designed to assess safety, efficacy, pharmacokinetics, and pharmacodynamics.[2]

Safety means whether the treatment causes unwanted medical problems, and the trial lists several safety measures such as dose-limiting toxicities, treatment-emergent adverse events, serious adverse events, dose reduction or stopping the study drug because of toxicity, physical examination findings, ECOG performance status, laboratory changes, ECGs, LVEF, and vital signs.[2]

Pharmacokinetics means how the body handles the study drug over time.[2] The study measures Tmax, Cmax, Cmin, AUC, and half-life for DCC-3014 and its metabolite DP-7005 if detected.[2]

The trial also includes an expansion cohort for TGCT, where effectiveness is measured by ORR at Week 25 and duration of response, which is the time from response until the disease gets worse or the patient dies.[2]

The brief summary says the study also aims to find the maximum tolerated dose and the recommended Phase 2 dose.[2]

What the trials measure

The two studies use different endpoints, but both are focused on learning whether the treatment helps patients and whether it can be studied safely.[1][2]

  • Objective response rate is the main outcome in both studies for TGCT, and it counts complete and partial responses.[1][2]
  • Duration of response shows how long the tumor response lasts after it is first seen.[2]
  • Safety measures include symptoms, exam findings, lab tests, heart tracing tests, and vital signs.[2]
  • Pharmacokinetic measures show how much drug is in the body and how long it stays there.[2]
  • RECIST v1.1 is the scan-based system used to judge tumor change in a standard way.[1][2]

Who may join these trials

The Phase 3 study includes patients with tenosynovial giant cell tumor.[1] The Phase 1/2 study includes patients with advanced tumors and tenosynovial giant cell tumor.[2]

The trial data provided do not list the full entry rules, such as age limits, prior treatments, or lab requirements.[1][2] Because of that, the safest summary is that eligibility depends on the study-specific criteria not shown in the source text.[1][2]

Important study design terms

Randomized means patients are placed into study groups by chance, not by choice.[1]

Double blinded means neither the patient nor the researcher knows which treatment is given during that study part.[1]

Open-label means everyone knows which treatment is being used.[1][2]

Multicenter means the study is done at more than one site or hospital.[1][2]

Interventional means the researchers give a study treatment and measure what happens next.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT05059262 Phase 3 Tenosynovial Giant Cell Tumor Authorised 123
NCT03069469 Phase 1/2 Advanced Tumors and Tenosynovial Giant Cell Tumor Authorised 135

FAQ

  • What conditions are being studied in Vimseltinib trials? The trials are studying tenosynovial giant cell tumor, also called TGCT. One study also includes patients with advanced tumors.
  • What phases are the Vimseltinib trials? The trial data include a Phase 3 study and a Phase 1/2 study. Phase 1/2 focuses on early testing, while Phase 3 compares Vimseltinib with placebo in a larger group.
  • What is the main goal of the Phase 3 trial? The Phase 3 trial is checking anti-tumor activity in TGCT. It measures objective response rate, which means how many patients have a complete or partial shrinkage of the tumor.
  • What does the Phase 1/2 study measure? The Phase 1/2 study looks at safety, tolerability, drug levels in the body, and early signs of effectiveness. It also checks the best dose to use in later studies.
  • Who can take part in these trials? People with tenosynovial giant cell tumor can take part in both studies, and the Phase 1/2 study also includes patients with advanced tumors. Exact entry rules are not listed in the trial data provided.

Ongoing Clinical Trials on Vimseltinib

  • Study on Vimseltinib for Patients with Tenosynovial Giant Cell Tumor

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Norway Poland +1

  • Study on the Safety and Effects of Vimseltinib for Patients with Advanced Tumors and Tenosynovial Giant Cell Tumor

    Not recruiting

    2 1 1
    Investigated drugs:
    France Italy The Netherlands Poland Spain

Glossary

  • Tenosynovial Giant Cell Tumor (TGCT): A tumor that affects the tissue around joints and tendons. It is the main condition studied in these trials.
  • Advanced tumors: Cancers that are more widespread or harder to treat. One trial includes patients with this type of disease.
  • Phase 1/2: An early stage of clinical research. It usually checks safety first and also looks for early signs that the treatment may work.
  • Phase 3: A later stage of research. It compares a treatment with another option, such as placebo, in a larger group of patients.
  • Placebo: A treatment that looks like the study drug but does not contain the active study medicine.
  • Open-label: A study where patients and researchers know which treatment is being given.
  • Double blinded: A study design where neither the patients nor the researchers know who is getting the study drug or placebo during that part of the trial.
  • Objective response rate (ORR): The percent of patients whose tumors shrink enough to count as a complete response or partial response.
  • Complete response (CR): No visible signs of the tumor on scans or exams used in the study.
  • Partial response (PR): The tumor gets smaller, but does not disappear completely.
  • RECIST v1.1: A standard way to measure whether a tumor is shrinking, staying the same, or growing in a clinical trial.
  • Pharmacokinetics (PK): How the body absorbs, moves, and removes a drug. The trial measures drug levels over time.

References