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NCT04824794 · OUTCOME

Dose Escalation, Expansion Part A and Expansion Part B: Pre-dose (Trough) Concentrations (Ctrough) of GEN3014

GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies · Source last updated 2026-05-19

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

Measure
GEOMETRIC_MEAN
Unit
ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Dose Escalation: Cycle (C) 1 Day (D) 1, C1D8 (RRMM GEN3014 0.2/0.6 mg/kg, R/R AML Dose Escalation), C2D1, Expansion Part A: C1D1, C2D1 (R/R DLBCL Expansion Part A: C1D8 and C2D8) Expansion Part B: C1D1, C1D8, C2D1, C3D1, C7D1, C8D1 (cycle = 28 days)

What was measured

Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.

Analysis population: PK Analysis Set=all participants exposed to GEN3014 with 1+ PK sample with a valid bioanalytical result. Overall number of participants analyzed= participants evaluable for the outcome measure. Number analyzed=participants evaluable at specified timepoint.

Groups in this outcome

RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg

Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).

RRMM Dose Escalation: GEN3014 2 mg/kg

Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.

RRMM Dose Escalation: GEN3014 4 mg/kg

Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.

RRMM Dose Escalation: GEN3014 8 mg/kg

Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.

RRMM Dose Escalation: GEN3014 16 mg/kg

Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.

RRMM Dose Escalation: GEN3014 24 mg/kg

Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.

R/R AML Dose Escalation: GEN3014 Dose Level 1

Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.

RRMM Expansion Part A: GEN3014

Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.

R/R DLBCL Expansion Part A: GEN3014

Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.

RRMM Expansion Part B: Daratumumab

Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.

RRMM Expansion Part B: GEN3014

Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.

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

Analysis denominator · Participants

GroupSource count
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg1
RRMM Dose Escalation: GEN3014 2 mg/kg0
RRMM Dose Escalation: GEN3014 4 mg/kg2
RRMM Dose Escalation: GEN3014 8 mg/kg3
RRMM Dose Escalation: GEN3014 16 mg/kg9
RRMM Dose Escalation: GEN3014 24 mg/kg5
R/R AML Dose Escalation: GEN3014 Dose Level 12
RRMM Expansion Part A: GEN30148
R/R DLBCL Expansion Part A: GEN30142
RRMM Expansion Part B: Daratumumab42
RRMM Expansion Part B: GEN301440

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg0
RRMM Dose Escalation: GEN3014 2 mg/kg0
RRMM Dose Escalation: GEN3014 4 mg/kg2
RRMM Dose Escalation: GEN3014 8 mg/kg3
RRMM Dose Escalation: GEN3014 16 mg/kg7
RRMM Dose Escalation: GEN3014 24 mg/kg5
R/R AML Dose Escalation: GEN3014 Dose Level 10
RRMM Expansion Part A: GEN30148
R/R DLBCL Expansion Part A: GEN30140
RRMM Expansion Part B: Daratumumab42
RRMM Expansion Part B: GEN301440
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
RRMM Dose Escalation: GEN3014 4 mg/kg7.8266118.8997Not reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 8 mg/kg21.597761.8541Not reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 16 mg/kg46.913446.6923Not reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 24 mg/kg32.831947.9974Not reportedNot reportedNot reported
RRMM Expansion Part A: GEN301410.9593919.6537Not reportedNot reportedNot reported
RRMM Expansion Part B: Daratumumab0.10000.0000Not reportedNot reportedNot reported
RRMM Expansion Part B: GEN30140.0308152.5985Not reportedNot reportedNot reported
Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg1
RRMM Dose Escalation: GEN3014 2 mg/kg0
RRMM Dose Escalation: GEN3014 4 mg/kg0
RRMM Dose Escalation: GEN3014 8 mg/kg0
RRMM Dose Escalation: GEN3014 16 mg/kg0
RRMM Dose Escalation: GEN3014 24 mg/kg0
R/R AML Dose Escalation: GEN3014 Dose Level 12
RRMM Expansion Part A: GEN30140
R/R DLBCL Expansion Part A: GEN30142
RRMM Expansion Part B: Daratumumab42
RRMM Expansion Part B: GEN301436
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg0.1740Not reportedNot reportedNot reportedNot reported
R/R AML Dose Escalation: GEN3014 Dose Level 11.97422031.9082Not reportedNot reportedNot reported
R/R DLBCL Expansion Part A: GEN301447.946827.9291Not reportedNot reportedNot reported
RRMM Expansion Part B: Daratumumab141.176148.3833Not reportedNot reportedNot reported
RRMM Expansion Part B: GEN301411.6922726.2018Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg1
RRMM Dose Escalation: GEN3014 2 mg/kg0
RRMM Dose Escalation: GEN3014 4 mg/kg2
RRMM Dose Escalation: GEN3014 8 mg/kg3
RRMM Dose Escalation: GEN3014 16 mg/kg9
RRMM Dose Escalation: GEN3014 24 mg/kg2
R/R AML Dose Escalation: GEN3014 Dose Level 10
RRMM Expansion Part A: GEN30147
R/R DLBCL Expansion Part A: GEN30140
RRMM Expansion Part B: Daratumumab40
RRMM Expansion Part B: GEN301435
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg0.3480Not reportedNot reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 4 mg/kg24.02716.1841Not reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 8 mg/kg37.313752.2777Not reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 16 mg/kg62.833482.1993Not reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 24 mg/kg22.3508342.0062Not reportedNot reportedNot reported
RRMM Expansion Part A: GEN301435.227796.6703Not reportedNot reportedNot reported
RRMM Expansion Part B: Daratumumab456.800344.9599Not reportedNot reportedNot reported
RRMM Expansion Part B: GEN301412.99161603.8261Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg0
RRMM Dose Escalation: GEN3014 2 mg/kg0
RRMM Dose Escalation: GEN3014 4 mg/kg0
RRMM Dose Escalation: GEN3014 8 mg/kg0
RRMM Dose Escalation: GEN3014 16 mg/kg0
RRMM Dose Escalation: GEN3014 24 mg/kg0
R/R AML Dose Escalation: GEN3014 Dose Level 10
RRMM Expansion Part A: GEN30140
R/R DLBCL Expansion Part A: GEN30140
RRMM Expansion Part B: Daratumumab37
RRMM Expansion Part B: GEN301432
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
RRMM Expansion Part B: Daratumumab639.653161.6900Not reportedNot reportedNot reported
RRMM Expansion Part B: GEN301422.1846313.1853Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg0
RRMM Dose Escalation: GEN3014 2 mg/kg0
RRMM Dose Escalation: GEN3014 4 mg/kg0
RRMM Dose Escalation: GEN3014 8 mg/kg0
RRMM Dose Escalation: GEN3014 16 mg/kg0
RRMM Dose Escalation: GEN3014 24 mg/kg0
R/R AML Dose Escalation: GEN3014 Dose Level 10
RRMM Expansion Part A: GEN30140
R/R DLBCL Expansion Part A: GEN30140
RRMM Expansion Part B: Daratumumab9
RRMM Expansion Part B: GEN30146
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
RRMM Expansion Part B: Daratumumab461.9240111.2876Not reportedNot reportedNot reported
RRMM Expansion Part B: GEN30148.76276849.5386Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg0
RRMM Dose Escalation: GEN3014 2 mg/kg0
RRMM Dose Escalation: GEN3014 4 mg/kg0
RRMM Dose Escalation: GEN3014 8 mg/kg0
RRMM Dose Escalation: GEN3014 16 mg/kg0
RRMM Dose Escalation: GEN3014 24 mg/kg0
R/R AML Dose Escalation: GEN3014 Dose Level 10
RRMM Expansion Part A: GEN30140
R/R DLBCL Expansion Part A: GEN30140
RRMM Expansion Part B: Daratumumab7
RRMM Expansion Part B: GEN30145
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
RRMM Expansion Part B: Daratumumab421.3880155.1497Not reportedNot reportedNot reported
RRMM Expansion Part B: GEN30141.34971720.9012Not reportedNot reportedNot reported
Cycle 2 Day 8

Analysis denominator · Participants

GroupSource count
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg0
RRMM Dose Escalation: GEN3014 2 mg/kg0
RRMM Dose Escalation: GEN3014 4 mg/kg0
RRMM Dose Escalation: GEN3014 8 mg/kg0
RRMM Dose Escalation: GEN3014 16 mg/kg0
RRMM Dose Escalation: GEN3014 24 mg/kg0
R/R AML Dose Escalation: GEN3014 Dose Level 10
RRMM Expansion Part A: GEN30140
R/R DLBCL Expansion Part A: GEN30141
RRMM Expansion Part B: Daratumumab0
RRMM Expansion Part B: GEN30140
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
R/R DLBCL Expansion Part A: GEN301482.4000Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG002
        spread
        118.8997
        value
        7.8266
      2. group Id
        OG003
        spread
        61.8541
        value
        21.5977
      3. group Id
        OG004
        spread
        46.6923
        value
        46.9134
      4. group Id
        OG005
        spread
        47.9974
        value
        32.8319
      5. group Id
        OG007
        spread
        919.6537
        value
        10.9593
      6. group Id
        OG009
        spread
        0.0000
        value
        0.1000
      7. group Id
        OG010
        spread
        152.5985
        value
        0.0308
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        8
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        42
      11. group Id
        OG010
        value
        40
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.1740
      2. group Id
        OG006
        spread
        2031.9082
        value
        1.9742
      3. group Id
        OG008
        spread
        27.9291
        value
        47.9468
      4. group Id
        OG009
        spread
        48.3833
        value
        141.1761
      5. group Id
        OG010
        spread
        726.2018
        value
        11.6922
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        2
      10. group Id
        OG009
        value
        42
      11. group Id
        OG010
        value
        36
      units
      Participants
    title
    Cycle 1 Day 8
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.3480
      2. group Id
        OG002
        spread
        6.1841
        value
        24.0271
      3. group Id
        OG003
        spread
        52.2777
        value
        37.3137
      4. group Id
        OG004
        spread
        82.1993
        value
        62.8334
      5. group Id
        OG005
        spread
        342.0062
        value
        22.3508
      6. group Id
        OG007
        spread
        96.6703
        value
        35.2277
      7. group Id
        OG009
        spread
        44.9599
        value
        456.8003
      8. group Id
        OG010
        spread
        1603.8261
        value
        12.9916
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        7
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        40
      11. group Id
        OG010
        value
        35
      units
      Participants
    title
    Cycle 2 Day 1
  4. categories
    1. measurements
      1. group Id
        OG009
        spread
        61.6900
        value
        639.6531
      2. group Id
        OG010
        spread
        313.1853
        value
        22.1846
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        37
      11. group Id
        OG010
        value
        32
      units
      Participants
    title
    Cycle 3 Day 1
  5. categories
    1. measurements
      1. group Id
        OG009
        spread
        111.2876
        value
        461.9240
      2. group Id
        OG010
        spread
        6849.5386
        value
        8.7627
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        9
      11. group Id
        OG010
        value
        6
      units
      Participants
    title
    Cycle 7 Day 1
  6. categories
    1. measurements
      1. group Id
        OG009
        spread
        155.1497
        value
        421.3880
      2. group Id
        OG010
        spread
        1720.9012
        value
        1.3497
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        7
      11. group Id
        OG010
        value
        5
      units
      Participants
    title
    Cycle 8 Day 1
  7. categories
    1. measurements
      1. group Id
        OG008
        value
        82.4000
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      units
      Participants
    title
    Cycle 2 Day 8
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      9
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      2
    8. group Id
      OG007
      value
      8
    9. group Id
      OG008
      value
      2
    10. group Id
      OG009
      value
      42
    11. group Id
      OG010
      value
      40
    units
    Participants
description
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
    id
    OG000
    title
    RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
  2. description
    Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
    id
    OG001
    title
    RRMM Dose Escalation: GEN3014 2 mg/kg
  3. description
    Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
    id
    OG002
    title
    RRMM Dose Escalation: GEN3014 4 mg/kg
  4. description
    Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
    id
    OG003
    title
    RRMM Dose Escalation: GEN3014 8 mg/kg
  5. description
    Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
    id
    OG004
    title
    RRMM Dose Escalation: GEN3014 16 mg/kg
  6. description
    Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
    id
    OG005
    title
    RRMM Dose Escalation: GEN3014 24 mg/kg
  7. description
    Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
    id
    OG006
    title
    R/R AML Dose Escalation: GEN3014 Dose Level 1
  8. description
    Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
    id
    OG007
    title
    RRMM Expansion Part A: GEN3014
  9. description
    Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
    id
    OG008
    title
    R/R DLBCL Expansion Part A: GEN3014
  10. description
    Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
    id
    OG009
    title
    RRMM Expansion Part B: Daratumumab
  11. description
    Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
    id
    OG010
    title
    RRMM Expansion Part B: GEN3014
param Type
GEOMETRIC_MEAN
population Description
PK Analysis Set=all participants exposed to GEN3014 with 1+ PK sample with a valid bioanalytical result. Overall number of participants analyzed= participants evaluable for the outcome measure. Number analyzed=participants evaluable at specified timepoint.
reporting Status
POSTED
time Frame
Dose Escalation: Cycle (C) 1 Day (D) 1, C1D8 (RRMM GEN3014 0.2/0.6 mg/kg, R/R AML Dose Escalation), C2D1, Expansion Part A: C1D1, C2D1 (R/R DLBCL Expansion Part A: C1D8 and C2D8) Expansion Part B: C1D1, C1D8, C2D1, C3D1, C7D1, C8D1 (cycle = 28 days)
title
Dose Escalation, Expansion Part A and Expansion Part B: Pre-dose (Trough) Concentrations (Ctrough) of GEN3014
type
SECONDARY
unit Of Measure
ug/mL

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Preserved source evidence · Not medical advice