Trial · NCT02264613
ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas
NCT02264613, Phase 1, Phase 2, Completed, Aileron Therapeutics, Inc.; results first posted 2026-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas. Trials, record NCT02264613. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02264613
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas
- NCT number
- NCT02264613
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 142 participants, actual
- Lead sponsor
- Aileron Therapeutics, Inc.
- Conditions
- Solid Tumor, Lymphoma, Peripheral T-Cell Lymphoma
- Interventions
- ALRN-6924
- First posted
- 2014-10-15
- Last updated
- 2026-01-13
- Results first posted
- 2026-01-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | 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 | Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0 |
| Primary | Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists, Expansion | 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 | Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0 |
| Primary | Determine the Maximum Tolerated Dose (MTD) of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas | 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 | Determine the maximum tolerated dose (MTD) |
| Primary | Determine Overall Response Rate | 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 | 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). |
| Secondary | Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response | 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 | 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). |
| Secondary | Determine Pharmacokinetic Parameters of ALRN-6924 When Administered to Patients With Advanced Solid Tumors or Lymphomas | 8 weeks | Time of Peak Plasma Concentration (Tmax) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists, Expansion | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Determine the Maximum Tolerated Dose (MTD) of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas | 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 | mg/kg | NUMBER | |
| PRIMARY | Determine Overall Response Rate | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Determine Pharmacokinetic Parameters of ALRN-6924 When Administered to Patients With Advanced Solid Tumors or Lymphomas | 8 weeks | The Pharmacokinetic Analysis Population included all subjects who received at least one dose of ALRN-6924 with sufficient plasma sample data to assess PK parameters, and with no major protocol violations. Plasma samples for subjects in the Combination With Palbociclib Expansion arm were collected but will not be processed or analyzed due to a protocol-level decision for this expansion arm to discontinue pharmacokinetic data collection. | hour | MEDIAN |
Source ClinicalTrials.gov
Results by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Dose Regimen A (DR-A) Escalation (0.16 mg/kg) | 5 | Participants | ||
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Dose Regimen A (DR-A) Escalation (0.32 mg/kg) | 3 | Participants | ||
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Dose Regimen A (DR-A) Escalation (0.64 mg/kg) | 4 | Participants | ||
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation | 3 | Participants | ||
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation | 6 | Participants | ||
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation | 9 | Participants | ||
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation | 11 | Participants | ||
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Dose Regimen B (DR-B) Escalation (0.32 mg/kg) | 3 | Participants | ||
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Dose Regimen B (DR-B) Escalation (0.53 mg/kg) | 5 | Participants | ||
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Dose Regimen B (DR-B) Escalation (0.80 mg/kg) | 3 | Participants |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow51
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Regimen A (DR-A) Escalation (0.16 mg/kg) | 5 | |
| Overall Study | STARTED | Dose Regimen A (DR-A) Escalation (0.32 mg/kg) | 3 | |
| Overall Study | STARTED | Dose Regimen A (DR-A) Escalation (0.64 mg/kg) | 4 | |
| Overall Study | STARTED | Dose Regimen A (DR-A) Escalation (1.25 mg/kg) | 3 | |
| Overall Study | STARTED | Dose Regimen A (DR-A) Escalation (2.10 mg/kg) | 6 | |
| Overall Study | STARTED | Dose Regiment A (DR-A) Escalation (3.10 mg/kg) | 9 | |
| Overall Study | STARTED | Dose Regimen A (DR-A) Escalation (4.40 mg/kg) | 11 | |
| Overall Study | STARTED | Dose Regimen B (DR-B) Escalation (0.32 mg/kg) | 3 | |
| Overall Study | STARTED | Dose Regimen B (DR-B) Escalation (0.53 mg/kg) | 5 | |
| Overall Study | STARTED | Dose Regimen B (DR-B) Escalation (0.80 mg/kg) | 3 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 participant flowAdverse events952
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Dose Regimen A (DR-A) Escalation (0.16 mg/kg) | 1 | 5 | 1 |
| other | Nausea | Gastrointestinal disorders | Dose Regimen A (DR-A) Escalation (0.32 mg/kg) | 1 | 3 | 1 |
| other | Nausea | Gastrointestinal disorders | Dose Regimen A (DR-A) Escalation (0.64 mg/kg) | 2 | 4 | 2 |
| other | Nausea | Gastrointestinal disorders | Dose Regimen A (DR-A) Escalation (1.25 mg/kg) | 3 | 3 | 3 |
| other | Nausea | Gastrointestinal disorders | Dose Regimen A (DR-A) Escalation (2.1 mg/kg) | 5 | 6 | 5 |
| other | Nausea | Gastrointestinal disorders | Dose Regimen A (DR-A) Escalation (3.1 mg/kg) | 9 | 9 | 9 |
| other | Nausea | Gastrointestinal disorders | Dose Regimen A (DR-A) Escalation (4.4 mg/kg) | 6 | 11 | 6 |
| other | Nausea | Gastrointestinal disorders | Dose Regimen B (DR-B) Escalation (0.32 mg/kg) | 3 | 3 | 3 |
| other | Nausea | Gastrointestinal disorders | Dose Regimen B (DR-B) Escalation (0.53 mg/kg) | 4 | 5 | 4 |
| other | Nausea | Gastrointestinal disorders | Dose Regimen B (DR-B) Escalation (0.8 mg/kg) | 3 | 3 | 3 |
1 to 10 of 952Source ClinicalTrials.gov
See all 952 adverse eventsAdverse event totals51
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Regimen A (DR-A) Escalation (0.16 mg/kg) | 0 | 5 |
| Total, all-cause mortality | Dose Regimen A (DR-A) Escalation (0.32 mg/kg) | 0 | 3 |
| Total, all-cause mortality | Dose Regimen A (DR-A) Escalation (0.64 mg/kg) | 0 | 4 |
| Total, all-cause mortality | Dose Regimen A (DR-A) Escalation (1.25 mg/kg) | 0 | 3 |
| Total, all-cause mortality | Dose Regimen A (DR-A) Escalation (2.1 mg/kg) | 0 | 6 |
| Total, all-cause mortality | Dose Regimen A (DR-A) Escalation (3.1 mg/kg) | 0 | 9 |
| Total, all-cause mortality | Dose Regimen A (DR-A) Escalation (4.4 mg/kg) | 0 | 11 |
| Total, all-cause mortality | Dose Regimen B (DR-B) Escalation (0.32 mg/kg) | 0 | 3 |
| Total, all-cause mortality | Dose Regimen B (DR-B) Escalation (0.53 mg/kg) | 0 | 5 |
| Total, all-cause mortality | Dose Regimen B (DR-B) Escalation (0.8 mg/kg) | 0 | 3 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34230007 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dose Regimen A (DR-A) PTCL Expansion vs Dose Regimen C (DR-C) PTCL Expansion: Determine Overall Response Rate |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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