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ATTR-01

Clinical trials are investigating ATTR-01 in adults with select epithelial solid tumours. These studies aim to evaluate safety, tolerability, and anti-tumour activity, and some sub-protocols also look for the best dose for further development. The main study is a Phase 1/2 interventional trial.

Table of Contents

Trial overview

The available study is titled A Phase 1-2 Master Protocol to study intravenous ATTR-01 in adult participants with select epithelial solid tumours under multiple sub-protocols, also called ATTEST.[1]

This is an interventional study, which means participants receive the study treatment and the research team measures the results.[1]

The trial is currently listed as Authorised.[1]

Who is being studied

The trial is designed for adult participants with select epithelial solid tumours.[1]

“Epithelial” means the cancer starts in cells that line organs or body surfaces, and “solid tumours” means the cancer forms a mass or lump rather than being a blood cancer.[1]

The source data does not give more detailed inclusion or exclusion rules, so the exact patient group is limited to the information above.[1]

What the study measures

The main safety outcomes include the incidence of adverse events, which means how often unwanted medical problems happen during the study.[1]

Researchers also measure serious adverse events, dose limiting toxicities, stopping the investigational product because of toxicity, and clinically significant changes in vital signs or other safety checks.[1]

The study also looks at Objective Response Rate (ORR) from the first scan onward, using RECIST V1.1, which is a standard way to measure whether tumours shrink or disappear on scans.[1]

Another key endpoint is Duration of Response (DoR), which shows how long a tumour response lasts once it begins.[1]

The brief summary says the trial aims to evaluate safety and tolerability in select solid epithelial tumours, and also anti-tumour activity in these participants, although this does not apply to SP A.[1]

Study design and phases

This is a Phase 1/2 trial, which usually means an early study that first focuses on safety and then starts to look at whether the treatment may help the cancer.[1]

The trial uses a master protocol, meaning one main study plan can include several related sub-protocols.[1]

Some sub-protocols include dose escalation, which means the dose may be increased step by step to help determine the optimal dose for further development.[1]

The source data notes that this dose-finding goal applies where relevant for those sub-protocols, but not to every part of the trial.[1]

Trial status and size

The trial has an enrollment target of 60 participants.[1]

This number shows the planned study size, which helps researchers collect enough information on safety and early signs of activity.[1]

Because the study is authorised and still in an early phase, the main focus is on learning how ATTR-01 performs in the target cancer group rather than proving final treatment benefit.[1]

Trial ID Phase Condition studied Status Enrollment
2024-516722-59-00 Phase 1/2 Select epithelial solid tumours Authorised 60

FAQ

  • What is being studied in ATTR-01 clinical trials? The trials are studying ATTR-01 in adults with select epithelial solid tumours. The main goals are to assess safety, tolerability, and anti-tumour activity.
  • Who can take part in these trials? The trial is for adult participants with select epithelial solid tumours. The source data does not give more detailed eligibility rules.
  • What phase are the ATTR-01 trials? The study is a Phase 1/2 trial. This means it is an early study that looks at safety and also begins to assess whether the treatment may help.
  • What outcomes are measured in the trial? The study measures side effects, serious side effects, dose limiting toxicities, treatment stops due to toxicity, changes in vital signs, objective response rate, and duration of response.
  • Does the trial include dose-finding? Yes, some sub-protocols include dose escalation to help determine the optimal dose for further development. This does not apply to every part of the master protocol.

Ongoing Clinical Trials on ATTR-01

Unfortunately, we did not find any clinical trials matching the selected criteria. Try changing the filter settings or broadening the search criteria to see more available research participation opportunities.

Glossary

  • Adult participants: People who are 18 years or older and are able to join a clinical study if they meet the trial rules.
  • Select epithelial solid tumours: A group of solid cancers that start in epithelial cells, which are cells that line organs and body surfaces.
  • Master protocol: A main study plan that can include several related sub-studies under one overall trial.
  • Sub-protocol: A smaller part of a master protocol that follows its own study plan within the larger trial.
  • Phase 1/2: An early clinical trial stage that first focuses on safety and dose, then also looks for signs that the treatment may work.
  • Interventional study: A study where participants receive a treatment or intervention and researchers measure the results.
  • Safety and tolerability: How well people handle the study treatment and whether it causes problems that are acceptable or manageable.
  • Dose escalation: A research method where the study dose is increased step by step to find a suitable dose.
  • Objective Response Rate (ORR): The percentage of participants whose tumours shrink or disappear on scans using set study rules.
  • Duration of Response (DoR): How long a tumour response lasts after it first appears.
  • RECIST V1.1: A standard set of rules used in cancer trials to measure whether tumours have changed on scans.
  • Dose limiting toxicities (DLTs): Side effects that are severe enough to limit how much of a treatment can be given.

References

  1. https://clinicaltrials.gov/study/2024-516722-59-00