Study of Modakafusp Alfa in Combination with Daratumumab Subcutaneous in Multiple Myeloma Patients
Research type
Research Study
Full title
A Phase 1/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Modakafusp Alfa in Combination With Daratumumab Subcutaneous in Patients With Relapsed or Refractory Multiple Myeloma
IRAS ID
1006706
Contact name
Isha Majmudar
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc.
Eudract number
2022-002169-14
Research summary
This is a global study, open in about 40 centres worldwide, aimed at assessing the safety/tolerability and efficacy of the combination of modakafusp alfa with daratumumab subcutaneous (SC) in patients with multiple myeloma (MM), relapsing after 1 or more lines of therapy. Modakafusp alfa is a new investigational drug that is not approved anywhere. It is a biological agent to enhance the immune system which is critical to kill cancer cells. Daratumumab SC is an approved drug for the treatment of MM. This is the first time that these 2 drugs are combined to assess the safety/tolerability and anti-myeloma activity of this combination.. The study consists of 2 parts:
- Part 1: Modakafusp alfa dose will be steadily increased to define the tolerable dose(s), in terms of safety for the combination with daratumumab SC. The different doses for this part were chosen based on the known safety profile of modakafusp alfa as a single agent and the potential overlapping toxicities with daratumumab SC.
- Part 2: We will select 2 doses of interest among those tested in part 1 and compare them to further optimise dose selection.
Besides safety/tolerability and efficacy, other factors we will assess to select the best dose are pharmacokinetic (what the participant’s body does to the drug, how fast it is eliminated) and pharmacodynamic (what the drug does to the participant’s body). This information will be gathered using blood and/or bone marrow samples at different time points.We estimate that 58 patients will be enrolled, but this could vary depending on the data observed. The total length of participation will depend on the patient’s disease response to the combination but could be up to 5 years.
REC name
Wales REC 2
REC reference
23/WA/0004
Date of REC Opinion
20 Jul 2023
REC opinion
Further Information Favourable Opinion