In short
DS-3790A is a protein-based investigational substance with no marketing authorisation. It is being studied in a first-in-human Phase 1/2 trial in 420 participants with hematological malignancies. The trial, authorised in the EU, evaluates DS-3790A alone and in combination with epcoritamab or rituximab. Its main goals are safety and preliminary efficacy.
Key points
- DS-3790A is an investigational protein-based substance given as a solution for infusion.
- It is being studied in hematological malignancies (blood cancers).
- The trial is a Phase 1/2 first-in-human study with 420 planned participants.
- The study tests DS-3790A alone and in combination with epcoritamab or rituximab.
- The trial is currently authorised in the EU.
- Primary measures include safety and complete response.
What is DS-3790A?
DS-3790A is a protein-based substance of the type classified as "Protein - Other" in the registry records. It is an investigational substance, meaning it has no marketing authorisation in the product records. The company supplying the product is Daiichi Sankyo, Inc. DS-3790A falls within the therapeutic area of neoplasms, which are abnormal growths of tissue that can be cancerous.
How does DS-3790A work?
The registry records do not describe the mechanism of action of DS-3790A. It is known to be a protein-based substance, which suggests it is a biological medicine rather than a chemically synthesised small molecule. The trial's brief summary states that the study will assess the safety and preliminary efficacy of DS-3790A monotherapy and combination regimens, but it does not explain the molecular target.
Which conditions is DS-3790A being studied for?
- Hematological malignancies — cancers that affect the blood, bone marrow, and lymph nodes, such as leukemias, lymphomas, and multiple myeloma.
How is DS-3790A given?
DS-3790A is prepared as a solution for infusion. The route of administration is recorded as "other use" in the registry, which indicates it is given by a route other than the standard oral or intravenous categories. The trial also includes epcoritamab and rituximab as other drugs in the study, both given by the same "other use" route.
What do the clinical trials show?
There is one registered trial for DS-3790A: a first-in-human Phase 1/2 study in participants with hematological malignancies. The trial is authorised in the EU, meaning it has received regulatory approval to begin, and plans to enroll 420 participants. The study is interventional, meaning participants receive the investigational treatment as part of the trial design.
The trial has three primary outcome measures. The first assesses safety by counting the number of participants reporting dose-limiting toxicities, treatment-emergent adverse events, serious adverse events, adverse events of special interest, and deaths. Adverse events are graded using NCI-CTCAE version 5.0, a standard scale for classifying the severity of side effects. The second and third measures assess complete response — the disappearance of all signs of cancer — either by blinded independent central review or by investigator assessment, depending on the cohort.
The study includes a randomization optimization phase and a Phase 2 component, indicating that after initial dose-finding, participants may be assigned to different treatment groups to compare DS-3790A alone with DS-3790A in combination with epcoritamab or rituximab.
What side effects are known?
No side effect data for DS-3790A are provided in the registry records. Because this is a first-in-human trial, the safety profile is not yet established, and the trial itself is designed to measure dose-limiting toxicities and adverse events as primary outcomes.