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ADCE-D01

Clinical trials are investigating ADCE-D01 in people with soft tissue sarcoma. These studies are looking at safety, tolerability, and whether the treatment may help shrink tumors. The trial includes adults in early and later study phases.

Table of Contents

Trial overview

The main trial in the source data is ADCElerate 1, a first-in-human study of ADCE-D01 in soft tissue sarcoma.[1] It is an interventional study, which means people receive the study treatment and the research team measures the results.[1] The trial status is Authorised, and the planned enrollment is 280 participants.[1]

Study design and phases

This study is a Phase 1/2 trial.[1] Phase 1a is a dose escalation part, where the dose is increased step by step to help find the safest dose range.[1] Phase 1b is a dose confirmation part, which checks whether the chosen dose is suitable.[1] Phase 2 uses expansion cohorts, meaning larger groups of patients are studied to look more closely at activity and safety.[1]

Who can participate

The trial is designed for people with soft tissue sarcoma.[1] The source data does not give a full list of all entry rules, such as age limits or prior treatments, so only the cancer type can be confirmed from the provided information.[1]

What the study measures

In Phase 1a and Phase 1b, the study measures dose-limiting toxicities, which are side effects severe enough to affect dosing.[1] It also measures treatment-emergent adverse events, meaning health problems that start or get worse after treatment begins, along with changes in laboratory tests.[1] The researchers assess tolerability by looking at whether side effects lead to dose interruption, dose reduction, or stopping treatment.[1]

In Phase 2, the main efficacy measure is objective response rate, or ORR, based on RECIST v1.1 by investigator assessment.[1] ORR shows how many patients have a measurable tumor shrinkage.[1] The trial also measures the 3-month progression-free survival rate, which shows how many patients have not had their cancer get worse after three months.[1]

Main goals of the trial

The early goal of the study is to find the maximum tolerated dose and the recommended Phase 2 dose of ADCE-D01.[1] The study also aims to understand safety and tolerability in more detail.[1] In Phase 2, the goal changes to checking antitumor activity, which means whether the treatment may help fight the cancer, while continuing to monitor safety.[1]

Key terms explained

Interventional study means the researchers give a treatment and then measure what happens.[1] Expansion cohorts are larger patient groups used to gather more data after the first dose-finding steps.[1] NCI CTCAE v5.0 is a standard system used to grade side effects in cancer trials.[1]

The study data also uses the term causality, which means whether a side effect is thought to be related to the treatment.[1] Tolerability means how well patients can stay on the treatment without major problems.[1] These terms help the research team judge both safety and possible benefit in people with soft tissue sarcoma.[1]

Trial ID Phase Condition studied Status Enrollment
2024-516900-41-00 Phase 1/2 Soft Tissue Sarcoma Authorised 280

FAQ

  • What is being studied in ADCE-D01 clinical trials? The trials are studying ADCE-D01 as a treatment for soft tissue sarcoma. Researchers are checking safety, tolerability, and signs that the treatment may work against the cancer.
  • Who can take part in these trials? The trial is for people with soft tissue sarcoma. The source data does not list every exact entry rule, but it is a study in patients with this cancer.
  • What phases are included? This study is Phase 1/2. Phase 1 looks mainly at safety and finding the best dose, while Phase 2 looks more at how well the treatment may work.
  • What results are the researchers measuring? They are measuring dose-limiting toxicities, other treatment-related side effects, lab changes, and whether the tumor responds. They also look at progression-free survival, which means how long the cancer stays from getting worse.
  • What is the main goal of the study? The early part of the trial aims to find the maximum tolerated dose and the recommended Phase 2 dose. The later part aims to check antitumor activity, which means whether the treatment may help fight the tumor.

Ongoing Clinical Trials on ADCE-D01

  • Study of ADCE-D01 for Patients with Metastatic or Unresectable Soft Tissue Sarcoma

    Recruiting

    1 1
    Investigated drugs:
    Belgium France Germany

Glossary

  • Soft tissue sarcoma: A cancer that starts in the soft tissues of the body, such as muscle, fat, or connective tissue.
  • Phase 1/2: A study that combines early safety testing with a later look at how well the treatment may work.
  • Dose escalation: A step-by-step increase in dose levels to find the safest dose range.
  • Dose confirmation: A study step that checks whether the chosen dose is suitable and can be used more broadly.
  • Maximum tolerated dose (MTD): The highest dose that most people can take without unacceptable side effects.
  • Recommended Phase 2 dose (RP2DS): The dose selected for later testing based on safety and other study results.
  • Dose-limiting toxicities (DLTs): Side effects that are severe enough to limit how much treatment can be given.
  • Treatment-emergent adverse events (TEAEs): Health problems that start or get worse after treatment begins.
  • Laboratory parameters: Test results from blood or other samples that help show how the body is responding to treatment.
  • RECIST v1.1: A standard way doctors use to measure whether a tumor is getting smaller, staying the same, or growing.
  • Objective response rate (ORR): The percentage of patients whose tumors shrink in a measurable way.
  • Progression-free survival (PFS): The length of time during and after treatment when the cancer does not get worse.

References

  1. https://clinicaltrials.gov/study/2024-516900-41-00