In short
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.
Key points
- TUB-030 is being studied in an early Phase 1/2 clinical trial for people with advanced solid tumors. The trial includes patients with head and neck squamous cell carcinoma and non-small-cell lung cancer. Researchers are first checking safety, tolerability, and dose limits, then looking for signs that the treatment may help control the cancer. They are also trying to find the recommended Phase II dose. The study measures side effects, tumor response, disease control, and how long any response lasts.
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).
This is an interventional study, which means researchers give the study treatment and then measure what happens.
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.
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.
It specifically includes patients with HNSCC and NSCLC.
The trial uses intravenous treatment, which means the study drug is given through a vein.
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.
They are also measuring treatment-emergent adverse events (TEAEs), which are health problems that appear or get worse after treatment starts.
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.
The study also measures TEAEs and treatment-related adverse events (TRAEs), which are side effects thought to be caused by the treatment.
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.
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.
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.
PK/PD means how the body handles the treatment and how the treatment affects the body.
Study status and size
The trial status is listed as Authorised.
The planned enrollment is 170 patients.
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.