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NCT05590377 · OUTCOME

Phase 1: Overall Response Rate (ORR)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Phase 1: Up to 15.9 months

What was measured

ORR is defined as the percentage of participants who achieved a confirmed PR or better during the study in the safety population. ORR will be assessed by the investigator per IMWG criteria.

Analysis population: The Response-evaluable Population included all participants who received at least 1 dose, even an incomplete dose, of any study drug, have a disease assessment at screening (baseline evaluation), and at least 1 postbaseline disease assessment.

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

GroupSource count
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab3
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab6
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab6

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab33.3Not reported0.8490.57Not reported
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab66.7Not reported22.2895.67Not reported
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab50.0Not reported11.8188.19Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.84
        upper Limit
        90.57
        value
        33.3
      2. group Id
        OG001
        lower Limit
        22.28
        upper Limit
        95.67
        value
        66.7
      3. group Id
        OG002
        lower Limit
        11.81
        upper Limit
        88.19
        value
        50.0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    units
    Participants
description
ORR is defined as the percentage of participants who achieved a confirmed PR or better during the study in the safety population. ORR will be assessed by the investigator per IMWG criteria.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
NUMBER
population Description
The Response-evaluable Population included all participants who received at least 1 dose, even an incomplete dose, of any study drug, have a disease assessment at screening (baseline evaluation), and at least 1 postbaseline disease assessment.
reporting Status
POSTED
time Frame
Phase 1: Up to 15.9 months
title
Phase 1: Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice