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TUB-030

Clinical trials are studying TUB-030 in people with advanced solid tumors, including head and neck squamous cell carcinoma and non-small-cell lung cancer. These studies aim to assess safety, tolerability, and signs of effect, and to help find the best dose for later testing.

Table of contents

Trial overview

The clinical trial NCT06657222 is studying TUB-030 in patients with advanced solid tumors, including head and neck squamous cell carcinoma (HNSCC) and non-small-cell lung cancer (NSCLC).[1]

This is an interventional study, which means researchers give the study treatment and then measure what happens.[1]

The trial is in Phase 1/2, so it is an early study that first focuses on safety and dose, then also looks for early signs of benefit.[1]

Who can join the study

The study is for patients with advanced or metastatic tumors, meaning cancers that have grown far or spread to other parts of the body.[1]

It specifically includes patients with HNSCC and NSCLC.[1]

The trial uses intravenous treatment, which means the study drug is given through a vein.[1]

What is being measured

In the dose escalation and backfill part, researchers are checking for dose-limiting toxicities (DLTs), which are side effects serious enough to limit how much treatment can be given.[1]

They are also measuring treatment-emergent adverse events (TEAEs), which are health problems that appear or get worse after treatment starts.[1]

In the dose optimization part, the study measures objective response rate (ORR), disease control rate (DCR), and duration of response (DoR) using RECIST v1.1, which is a standard way to measure how tumors change on scans.[1]

The study also measures TEAEs and treatment-related adverse events (TRAEs), which are side effects thought to be caused by the treatment.[1]

Study goals and dosing steps

One main goal is to find the maximum tolerated dose (MTD), which is the highest dose people can take without too many serious side effects.[1]

Another goal is to find the recommended Phase II dose (RP2D), which is the dose chosen for future studies based on safety, effect, and other data.[1]

The brief summary says the dose optimization decision will use the total picture of efficacy (how well the treatment works), safety, PK/PD data, and tolerability.[1]

PK/PD means how the body handles the treatment and how the treatment affects the body.[1]

Study status and size

The trial status is listed as Authorised.[1]

The planned enrollment is 170 patients.[1]

This size suggests the study is designed to gather enough information to understand safety, dose finding, and early signs of activity across the target cancer groups.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06657222 Phase 1/2 Advanced solid tumors, including HNSCC and NSCLC Authorised 170

FAQ

  • What is being studied in the TUB-030 trials? The trials are studying TUB-030 as a treatment for advanced solid tumors. Researchers are looking at safety, tolerability, and whether the treatment shows signs of helping the cancer.
  • Who can take part in these trials? The study includes patients with advanced or metastatic tumors. It specifically mentions people with head and neck squamous cell carcinoma and non-small-cell lung cancer.
  • What phase are the TUB-030 trials? The trial is in Phase 1/2. This means it is an early study that first checks safety and dose, and then looks more closely at possible benefit.
  • What are the main goals of the study? One goal is to find the maximum tolerated dose, which is the highest dose people can take without too many serious side effects. Another goal is to find the recommended Phase II dose, which is the dose chosen for later studies.
  • What results are the researchers measuring? Researchers are measuring dose-limiting toxicities, treatment-emergent adverse events, and treatment-related side effects. They are also measuring tumor response, disease control, and how long the response lasts.

Ongoing Clinical Trials on TUB-030

  • Testing the Safety and Effects of TUB-030 in Patients with Advanced Head and Neck Cancer or Non-Small-Cell Lung Cancer

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Romania Spain

Glossary

  • Advanced solid tumors: Solid cancers that have grown or spread and are harder to treat. 'Solid' means the cancer forms a tumor, not a blood cancer.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Head and neck squamous cell carcinoma (HNSCC): A cancer that starts in the thin cells lining the head and neck area, such as the mouth, throat, or voice box.
  • Non-small-cell lung cancer (NSCLC): The most common type of lung cancer. It grows and behaves differently from small-cell lung cancer.
  • Interventional study: A study where researchers give a treatment and measure what happens.
  • Phase 1/2: An early stage of clinical research. Phase 1 mainly checks safety and dose, while Phase 2 looks more closely at whether the treatment may work.
  • Dose-limiting toxicities (DLTs): Side effects that are serious enough to limit how much of a treatment can be given.
  • Treatment-emergent adverse events (TEAEs): Health problems that appear or get worse after treatment starts, whether or not they are caused by the treatment.
  • Treatment-related adverse events (TRAEs): Side effects that researchers think are caused by the treatment.
  • Objective response rate (ORR): The percentage of patients whose tumors shrink by a set amount.
  • Disease control rate (DCR): The percentage of patients whose cancer shrinks or stays stable for a period of time.
  • Duration of response (DoR): How long a tumor response lasts after it begins.

References