NCT05590377 · OUTCOME

Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies (ADA)

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma · Source last updated 2026-01-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 15.9 months

What was measured

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

Analysis population: Immunogenicity-evaluable Population included participants who received at least 1 dose of modakafusp alfa in combination with daratumumab SC (partial or complete) with a baseline assessment \& at least 1 postbaseline immunogenicity assessment. No data was collected for this outcome measure due to study termination. Overall number of participants analyzed is the number of participants with data available for analyses.

Groups in this outcome

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

Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.

Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab

Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.

Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab

Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab	3
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab	6
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab	0

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab	3	Not reported	Not reported	Not reported	Not reported
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab	2	Not reported	Not reported	Not reported	Not reported
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
0

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
0
units
Participants

description

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

groups

description
Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.
id
OG000
title
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
description
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.
id
OG001
title
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
description
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.
id
OG002
title
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab

param Type

COUNT_OF_PARTICIPANTS

population Description

Immunogenicity-evaluable Population included participants who received at least 1 dose of modakafusp alfa in combination with daratumumab SC (partial or complete) with a baseline assessment \& at least 1 postbaseline immunogenicity assessment. No data was collected for this outcome measure due to study termination. Overall number of participants analyzed is the number of participants with data available for analyses.

reporting Status

POSTED

time Frame

Up to 15.9 months

title

Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies (ADA)

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice