NCT05590377|TerminatedPhase 1ResultsFDA Drug

Study Stopped

After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. Thus, no participants were enrolled for Phase 2a and the study was terminated early.

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma

iinnovate-3

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

Teva Branded Pharmaceutical Products R&D LLC ClinicalTrials.gov

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2 other identifiers

TAK-573-20012022-002169-14

Study Type

interventional

Target

Locations

7 countries

Sites

Timeline

RegisteredOct 2022

StartedJan 2023

CompletionMay 2024

Brief Summary

The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline

Completed

Started Jan 2023

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach

7 countries

27 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

October 19, 2022

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed

3 months until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2024

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

August 6, 2025

Completed

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

October 19, 2022

Results QC Date

April 25, 2025

Last Update Submit

January 13, 2026

Conditions

Multiple Myeloma

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

Phase 1: Number of Participants With Dose Limiting Toxicities (DLT)
DLT was defined as any of the treatment-emergent adverse events (TEAEs) that occurred during Cycle 1 and were considered by the investigator to be at least possibly related to modakafusp alfa. Toxicity was evaluated according to national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 5.0.
Phase 1: Cycle 1 (cycle length=28 days)
Phase 1: Number of Participants Reporting One or More TEAEs and Per Severity
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs were evaluated as per the NCI CTCAE Version 5.0.
Phase 1: Up to 15.9 months
Phase 2a: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve a confirmed partial response (PR) or better during the study in the safety population. ORR will be assessed by the investigator per International Myeloma Working Group (IMWG) criteria.
Phase 2a: Up to 15.9 months

Secondary Outcomes (30)

Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Modakafusp Alfa
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Modakafusp Alfa
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
Phase 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
Phase 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
Phase 1: Apparent Serum Terminal Disposition Rate Constant for Modakafusp Alfa
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
+25 more secondary outcomes

Study Arms (5)

Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab

EXPERIMENTAL

Modakafusp alfa 80 mg, infusion, intravenously (IV), once every 4 weeks (Q4W) with daratumumab 1800 mg, subcutaneously (SC), once weekly (QW) in Cycles 1 and 2, twice weekly (Q2W) in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.