In short
DT-7012 is an investigational drug being studied in a Phase 1/2 clinical trial for people with selected advanced solid tumours. The trial, which is authorised but not yet recruiting, plans to enrol 125 participants and will test DT-7012 both on its own and in combination with pembrolizumab, an immune checkpoint inhibitor.
Key points
- DT-7012 is an investigational substance with no marketing authorisation in these records.
- The trial is in Phase 1/2 and is currently authorised but not yet recruiting.
- It will enrol 125 participants with selected advanced solid tumours.
- DT-7012 is given as an intravenous infusion.
- The trial will test DT-7012 alone and in combination with pembrolizumab.
- The main measures are safety and tolerability, including dose-limiting toxicities.
What is DT-7012?
DT-7012 is an investigational substance being studied for use in people with cancer. It is not yet an authorised medicine, and no marketing authorisation appears in the registry records for this substance. The trial record from the EU Clinical Trials Information System (CTIS) lists the substance under the name DT-7012, which is the name used throughout this page.
How does DT-7012 work?
The available trial records do not describe the mechanism of action of DT-7012. The brief summary provided by the sponsor focuses on determining the maximum tolerated dose or maximum administered dose of DT-7012 as monotherapy, and on assessing the safety and tolerability of DT-7012 when administered in combination with pembrolizumab. Because DT-7012 is being studied in combination with an immune checkpoint inhibitor, the trial is designed to explore whether the two approaches can be given together safely.
Which conditions is DT-7012 being studied for?
The trial register lists a single condition area for DT-7012:
- Cancer — specifically, selected advanced solid tumours. The trial record describes the population as participants with selected advanced solid tumours, meaning the cancer has spread or is locally advanced and is no longer confined to the organ where it started.
How is DT-7012 given?
In the clinical trial, DT-7012 is given as an intravenous infusion, meaning it is delivered directly into a vein over a period of time. No other pharmaceutical forms or routes of administration appear in the registry records for this substance.
What do the clinical trials show?
There is one clinical trial of DT-7012 in the registry: a Phase 1/2 trial in participants with selected advanced solid tumours. The trial is authorised but not yet recruiting, which means it has received the necessary approvals to begin and is preparing to enrol participants. The planned enrolment is 125 participants.
The trial has two parts. In the dose escalation cohort, DT-7012 is given as monotherapy, and the aim is to determine the maximum tolerated dose or the maximum administered dose. In the combination dose escalation cohort, DT-7012 is given together with pembrolizumab, and the aim is to assess safety and tolerability of the combination.
The primary outcome measure is safety. The trial will record the occurrence of dose-limiting toxicities (DLTs) during the DLT observation period, as well as treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), adverse events of special interest (AESIs), serious adverse events (SAEs), and adverse events leading to treatment discontinuation. Dose-limiting toxicities are side effects that are severe enough to prevent increasing the dose further.
What side effects are known?
No side effects for DT-7012 are listed in the registry records. Because the trial is still in its early phase and has not yet reported results, the side effect profile of DT-7012 is not yet known. The trial is designed to measure adverse events as its primary outcome, so information about side effects will become available as the trial progresses.