Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04824794 · OUTCOME

Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
28 days during the first cycle (cycle =28 days)

What was measured

DLTs were defined as: All Grade 5 toxicities, Grade 4 thrombocytopenia, neutropenia or anemia and Grade 3/4 febrile neutropenia and hemorrhage associated with thrombocytopenia, all non-hematological toxicities of grade ≥3 (with exceptions per protocol), Grade 4 tumor lysis syndrome (TLS), Grade 4 infusion-related reaction (IRR), and any liver toxicity of elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times or greater above the upper limit of normal (ULN) with serum total bilirubin of ≥2 times the upper limit of normal, without findings of cholestasis and in the absence of alternative etiologies. DLTs were graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

Analysis population: Dose-Determining Analysis Set (DDS) included all FAS participants (all enrolled participants who received at least 1 dose of trial drug \[GEN3014 or daratumumab SC\]) in the Dose Escalation part who met the minimum exposure criterion and had sufficient safety evaluations or experienced a DLT during the first 28 days of dosing (ie, in Cycle 1).

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.

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/kg1
RRMM Dose Escalation: GEN3014 4 mg/kg3
RRMM Dose Escalation: GEN3014 8 mg/kg3
RRMM Dose Escalation: GEN3014 16 mg/kg11
RRMM Dose Escalation: GEN3014 24 mg/kg5
R/R AML Dose Escalation: GEN3014 Dose Level 15

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg0Not reportedNot reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 2 mg/kg0Not reportedNot reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 4 mg/kg0Not reportedNot reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 8 mg/kg0Not reportedNot reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 16 mg/kg0Not reportedNot reportedNot reportedNot reported
RRMM Dose Escalation: GEN3014 24 mg/kg1Not reportedNot reportedNot reportedNot reported
R/R AML Dose Escalation: GEN3014 Dose Level 10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      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
        1
      7. group Id
        OG006
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      11
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      5
    units
    Participants
description
DLTs were defined as: All Grade 5 toxicities, Grade 4 thrombocytopenia, neutropenia or anemia and Grade 3/4 febrile neutropenia and hemorrhage associated with thrombocytopenia, all non-hematological toxicities of grade ≥3 (with exceptions per protocol), Grade 4 tumor lysis syndrome (TLS), Grade 4 infusion-related reaction (IRR), and any liver toxicity of elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times or greater above the upper limit of normal (ULN) with serum total bilirubin of ≥2 times the upper limit of normal, without findings of cholestasis and in the absence of alternative etiologies. DLTs were graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
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
param Type
COUNT_OF_PARTICIPANTS
population Description
Dose-Determining Analysis Set (DDS) included all FAS participants (all enrolled participants who received at least 1 dose of trial drug \[GEN3014 or daratumumab SC\]) in the Dose Escalation part who met the minimum exposure criterion and had sufficient safety evaluations or experienced a DLT during the first 28 days of dosing (ie, in Cycle 1).
reporting Status
POSTED
time Frame
28 days during the first cycle (cycle =28 days)
title
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice