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NCT02264613 · OUTCOME

Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response

ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas · Source last updated 2026-01-13

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
From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days

What was measured

The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients).

Analysis population: The efficacy evaluable population was defined as those patients who met all of the following criteria: (1) Received at least 1 dose of ALRN-6924 at a dose level at least 0.8 mg/kg per infusion (2) Had at least 1 postbaseline evaluation or had clinical disease progression (3) Were TP53 wild type or indeterminate (as assessed by the central laboratory; if not assessed by central laboratory, as assessed by the local laboratory.

Groups in this outcome

Dose Regimen A (DR-A) Escalation (0.16 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (0.32 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (0.64 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (1.25 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (2.10 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (3.10 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (4.40 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (0.32 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (0.53 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (0.80 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (1.10 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (1.50 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (2.00 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (2.70 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) PTCL Expansion

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen C (DR-C) PTCL Expansion

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Combination With Palbociclib Expansion

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

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

Analysis denominator · Participants

GroupSource count
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)0
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)0
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)0
Dose Regimen A (DR-A) Escalation (1.25 mg/kg)2
Dose Regimen A (DR-A) Escalation (2.10 mg/kg)3
Dose Regimen A (DR-A) Escalation (3.10 mg/kg)7
Dose Regimen A (DR-A) Escalation (4.40 mg/kg)8
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)0
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)0
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)3
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)4
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)4
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)4
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)6
Dose Regimen A (DR-A) PTCL Expansion16
Dose Regimen C (DR-C) PTCL Expansion11
Combination With Palbociclib Expansion25

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)0Not reportedNot reportedNot reportedNot reported
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)0Not reportedNot reportedNot reportedNot reported
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)0Not reportedNot reportedNot reportedNot reported
Dose Regimen A (DR-A) Escalation (1.25 mg/kg)0Not reportedNot reportedNot reportedNot reported
Dose Regimen A (DR-A) Escalation (2.10 mg/kg)1Not reportedNot reportedNot reportedNot reported
Dose Regimen A (DR-A) Escalation (3.10 mg/kg)0Not reportedNot reportedNot reportedNot reported
Dose Regimen A (DR-A) Escalation (4.40 mg/kg)1Not reportedNot reportedNot reportedNot reported
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)0Not reportedNot reportedNot reportedNot reported
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)0Not reportedNot reportedNot reportedNot reported
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)1Not reportedNot reportedNot reportedNot reported
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)0Not reportedNot reportedNot reportedNot reported
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)0Not reportedNot reportedNot reportedNot reported
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)0Not reportedNot reportedNot reportedNot reported
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)1Not reportedNot reportedNot reportedNot reported
Dose Regimen A (DR-A) PTCL Expansion1Not reportedNot reportedNot reportedNot reported
Dose Regimen C (DR-C) PTCL Expansion1Not reportedNot reportedNot reportedNot reported
Combination With Palbociclib Expansion0Not 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
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
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
      2
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      7
    7. group Id
      OG006
      value
      8
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    10. group Id
      OG009
      value
      3
    11. group Id
      OG010
      value
      4
    12. group Id
      OG011
      value
      4
    units
    Participants
description
The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients).
groups
  1. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG000
    title
    Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
  2. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG001
    title
    Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
  3. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG002
    title
    Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
  4. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG003
    title
    Dose Regimen A (DR-A) Escalation (1.25 mg/kg)
  5. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG004
    title
    Dose Regimen A (DR-A) Escalation (2.10 mg/kg)
  6. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG005
    title
    Dose Regimen A (DR-A) Escalation (3.10 mg/kg)
  7. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG006
    title
    Dose Regimen A (DR-A) Escalation (4.40 mg/kg)
  8. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG007
    title
    Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
  9. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG008
    title
    Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
  10. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG009
    title
    Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
  11. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG010
    title
    Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
  12. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG011
    title
    Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
param Type
COUNT_OF_PARTICIPANTS
population Description
The efficacy evaluable population was defined as those patients who met all of the following criteria: (1) Received at least 1 dose of ALRN-6924 at a dose level at least 0.8 mg/kg per infusion (2) Had at least 1 postbaseline evaluation or had clinical disease progression (3) Were TP53 wild type or indeterminate (as assessed by the central laboratory; if not assessed by central laboratory, as assessed by the local laboratory.
reporting Status
POSTED
time Frame
From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
title
Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice