In short
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.
Key points
- Clinical trials of ADCE-D01 are studying soft tissue sarcoma. The main study is a Phase 1/2 trial called ADCElerate 1, which is authorised and plans to enroll 280 people. Early parts of the trial focus on safety, tolerability, and finding the best dose. Later parts look at tumor response and progression-free survival. The study includes dose escalation, dose confirmation, and expansion cohorts. Researchers are using standard cancer measures such as DLTs, TEAEs, ORR, and RECIST v1.1.
Trial overview
The main trial in the source data is ADCElerate 1, a first-in-human study of ADCE-D01 in soft tissue sarcoma. It is an interventional study, which means people receive the study treatment and the research team measures the results. The trial status is Authorised, and the planned enrollment is 280 participants.
Study design and phases
This study is a Phase 1/2 trial. Phase 1a is a dose escalation part, where the dose is increased step by step to help find the safest dose range. Phase 1b is a dose confirmation part, which checks whether the chosen dose is suitable. Phase 2 uses expansion cohorts, meaning larger groups of patients are studied to look more closely at activity and safety.
Who can participate
The trial is designed for people with soft tissue sarcoma. 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.
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. It also measures treatment-emergent adverse events, meaning health problems that start or get worse after treatment begins, along with changes in laboratory tests. The researchers assess tolerability by looking at whether side effects lead to dose interruption, dose reduction, or stopping treatment.
In Phase 2, the main efficacy measure is objective response rate, or ORR, based on RECIST v1.1 by investigator assessment. ORR shows how many patients have a measurable tumor shrinkage. 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.
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. The study also aims to understand safety and tolerability in more detail. 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.
Key terms explained
Interventional study means the researchers give a treatment and then measure what happens. Expansion cohorts are larger patient groups used to gather more data after the first dose-finding steps. NCI CTCAE v5.0 is a standard system used to grade side effects in cancer trials.
The study data also uses the term causality, which means whether a side effect is thought to be related to the treatment. Tolerability means how well patients can stay on the treatment without major problems. These terms help the research team judge both safety and possible benefit in people with soft tissue sarcoma.