Solid TumorPhase 1/2NCT02264613

ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas

A Phase 1/2 study testing ALRN-6924 in people with Solid Tumor and Lymphoma, run by Aileron Therapeutics, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with WT TP53. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Lymphoma, Peripheral T-Cell Lymphoma
What is being tested?: ALRN-6924
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 13 sitesUnited States
Study dates: Oct 2014to Apr 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed solid tumor or lymphoma that is not amenable to standard therapies.
Cohort specific biomarkers, including confirmed or anticipated WT TP53 (Phase 1 and PTCL expansion cohorts) and MDM2-amplification or MDM2/CDK4-co-amplification (solid tumor expansion cohort)
At least one target lesion that is measurable by RECIST 1.1, RANO or IWG 2014, as appropriate for tumor type
ECOG (Eastern Cooperative Oncology Group) performance status 0-1
Adequate coagulation and hematologic function
Adequate hepatic and renal function
Sufficient wash out from prior therapies and recovery from all significant acute toxicities

Who cannot join

Prior treatment with an MDM2 inhibitor, with protocol specified exceptions
Known hypersensitivity to any study drug component
Protocol specified cardiovascular risk factors
Clinically significant gastrointestinal bleeding within 6 months
Clinically significant third-space fluid accumulation
Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C

Show all 9Show fewer

HPV positive tumors
Second malignancy within two years, with protocol specified exceptions
Pregnancy or lactation

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Study site
Birmingham, Alabama, 35294
Study site
Boston, Massachusetts, 02114
Study site
Boston, Massachusetts, 02215
Study site
Denver, Colorado, 80218
Study site
Duarte, California, 91010
Study site
Greenville, South Carolina, 29605
Study site
Houston, Texas, 77030
Study site
Nashville, Tennessee, 37203
Study site
New York, New York, 10065
Study site
Sarasota, Florida, 34232
Study site
Seattle, Washington, 98105
Study site
Tampa, Florida, 33612
Study site
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: A Phase 1/2a Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 Alone or in Combination in Patients With Advanced Solid Tumors or Lymphomas Expressing Wild-Type p53 Protein

This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with WT TP53.

Read the detailed description

Open label, multi center, Phase 1 (dose escalation) and Phase 2a (dose expansion) study design to evaluate safety, tolerability, PK, PD and anti-tumor effects of ALRN-6924, alone or in combination with palbociclib, in patients with advanced solid tumors or lymphomas with wild-type (WT) TP53. ALRN-6924 is a stabilized cell-permeating peptide designed to disrupt the interaction between the p53 tumor suppressor protein and its predominant endogenous inhibitors, murine double minute 2 (MDM2) and murine double minute X (MDMX).

The Phase 1 portion of the study will enroll adults with histologically or cytologically confirmed malignancies that are metastatic or unresectable and for which standard treatment(s) are not available or are no longer effective. The Phase 2a portion of the study consists of separate cohorts that will enroll distinct groups of patients with specific solid tumors and/or lymphomas to further investigate the clinical safety profile and potential efficacy of ALRN-6924 alone or in a combination regimen.

Treatment will continue until unacceptable toxicity, patient or physician decision to discontinue therapy or disease progression that is either symptomatic, rapidly progressive, requires urgent intervention or is associated with a decline in performance status.

Patients with PTCL have been selected as a group to be further studied in Phase 2a.

Patients with MDM2-amplified or MDM2/CDK4-co-amplified solid tumors have been selected as another group to be further studied in Phase 2a.

Conditions: Solid Tumor, Lymphoma, Peripheral T-Cell Lymphoma
Being tested: ALRN-6924
Medical subject headings: Lymphoma, Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALRN-6924Drug
ALRN-6924 will be administered as an IV infusion

Study groups in NCT02264613
Study group	Role	What they receive
Dose Regimen A (DR-A)	Experimental	Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. Receives: Drug: ALRN-6924
Dose Regimen B (DR-B)	Experimental	Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle Receives: Drug: ALRN-6924
Dose Regimen C (DR-C)	Experimental	Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle Receives: Drug: ALRN-6924
Combination with palbociclib	Experimental	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 Receives: Drug: ALRN-6924

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
Measured: 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
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
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
Measured: 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) of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas
Determine the maximum tolerated dose (MTD)
Measured: 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 Overall Response Rate
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).
Measured: 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

Secondary outcomes (2)

Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response
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).
Measured: 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 Pharmacokinetic Parameters of ALRN-6924 When Administered to Patients With Advanced Solid Tumors or Lymphomas
Time of Peak Plasma Concentration (Tmax)
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Apr 2020

First posted15 Oct 2014 (estimated)
Study startOct 2014
Primary completionMar 2020
Study completionApr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02264613
Sponsor's protocol ID: ALRN-6924-1-01
Status last verified: Jan 2026
First submitted: 7 Oct 2014
Last updated: 13 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Zhou X, Singh M, Sanz Santos G, Guerlavais V, Carvajal LA, Aivado M, Zhan Y, Oliveira MMS, Westerberg LS, Annis DA, Johnsen JI, Selivanova G. Pharmacologic Activation of p53 Triggers Viral Mimicry Response Thereby Abolishing Tumor Immune Evasion and Promoting Antitumor Immunity. Cancer Discov. 2021 Dec 1;11(12):3090-3105. doi: 10.1158/2159-8290.CD-20-1741.
PubMed 34230007

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
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RecruitingPhase 2
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Solid Tumors

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 Alone or in Combination in Patients With Advanced Solid Tumors or Lymphomas Expressing Wild-Type p53 Protein
ClinicalTrials.gov ID: NCT02264613
Acronym / sponsor ID: ALRN-6924-1-01
Conditions: Solid Tumor, Lymphoma, Peripheral T-Cell Lymphoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Aileron Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2014 (actual)
Primary completion: Mar 2020 (actual)
Study completion: Apr 2020 (actual)
First posted: 15 Oct 2014 (estimated)
Results: Posted 13 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with WT TP53.

Detailed description

Patients with PTCL have been selected as a group to be further studied in Phase 2a.

Patients with MDM2-amplified or MDM2/CDK4-co-amplified solid tumors have been selected as another group to be further studied in Phase 2a.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Dose Regimen A (DR-A)	Experimental	Drug: ALRN-6924Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
Dose Regimen B (DR-B)	Experimental	Drug: ALRN-6924Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
Dose Regimen C (DR-C)	Experimental	Drug: ALRN-6924Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
Combination with palbociclib	Experimental	Drug: ALRN-6924Drug: 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Histologically or cytologically confirmed solid tumor or lymphoma that is not amenable to standard therapies.
Cohort specific biomarkers, including confirmed or anticipated WT TP53 (Phase 1 and PTCL expansion cohorts) and MDM2-amplification or MDM2/CDK4-co-amplification (solid tumor expansion cohort)
At least one target lesion that is measurable by RECIST 1.1, RANO or IWG 2014, as appropriate for tumor type
ECOG (Eastern Cooperative Oncology Group) performance status 0-1
Adequate coagulation and hematologic function

Key exclusion criteria (9 listed)

Prior treatment with an MDM2 inhibitor, with protocol specified exceptions
Known hypersensitivity to any study drug component
Protocol specified cardiovascular risk factors
Clinically significant gastrointestinal bleeding within 6 months
Clinically significant third-space fluid accumulation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALRN-6924ALRN-6924 will be administered as an IV infusion	Drug	Combination with palbociclib, Dose Regimen A (DR-A), Dose Regimen B (DR-B), Dose Regimen C (DR-C)

Primary outcome

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
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
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
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
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
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
Determine the Maximum Tolerated Dose (MTD) of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas
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
Determine the maximum tolerated dose (MTD)
Determine Overall Response Rate
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
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).

2 secondary outcomes

Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response
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
Determine Pharmacokinetic Parameters of ALRN-6924 When Administered to Patients With Advanced Solid Tumors or Lymphomas
Time frame: 8 weeks

Results and safety

Results posted to the registry on 13 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)	5	0
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)	3	0
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)	4	0
Dose Regimen A (DR-A) Escalation (1.25 mg/kg)	3	1
Dose Regimen A (DR-A) Escalation (2.10 mg/kg)	6	1
Dose Regiment A (DR-A) Escalation (3.10 mg/kg)	9	0
Dose Regimen A (DR-A) Escalation (4.40 mg/kg)	11	1
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)	3	0
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)	5	0
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)	3	0
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)	4	0
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)	4	0
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)	5	0
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)	6	2
Dose Regimen A (DR-A) PTCL Expansion	21	1
Dose Regimen C (DR-C) PTCL Expansion	16	0
Combination With Palbociclib Expansion	34	7

Primary outcome: 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

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. Count of participants. Unit: Participants

Measure	Dose Regimen A (DR-A) Escalation (0.16 mg/kg) n = 5	Dose Regimen A (DR-A) Escalation (0.32 mg/kg) n = 3	Dose Regimen A (DR-A) Escalation (0.64 mg/kg) n = 4	Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation n = 3	Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation n = 6	Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation n = 9	Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation n = 11	Dose Regimen B (DR-B) Escalation (0.32 mg/kg) n = 3	Dose Regimen B (DR-B) Escalation (0.53 mg/kg) n = 5	Dose Regimen B (DR-B) Escalation (0.80 mg/kg) n = 3	Dose Regimen B (DR-B) Escalation (1.10 mg/kg) n = 4	Dose Regimen B (DR-B) Escalation (1.50 mg/kg) n = 4	Dose Regimen B (DR-B) Escalation (2.00 mg/kg) n = 5	Dose Regimen B (DR-B) Escalation (2.70 mg/kg) n = 6	Dose Regimen A (DR-A) PTCL Expansion n = 21	Dose Regimen C (DR-C) PTCL Expansion n = 16	Combination With Palbociclib Expansion (DR-A) n = 34
Value	5	3	4	3	6	9	11	3	5	3	4	4	5	6	21	16	34

Primary outcome: 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

Measure	Dose Regimen A (DR-A) PTCL Expansion n = 21	Dose Regimen C (DR-C) PTCL Expansion n = 16	Combination With Palbociclib Expansion (DR-A) n = 34
Value	21	16	34

Primary outcome: Determine the Maximum Tolerated Dose (MTD) of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas

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. Number. Unit: mg/kg

Measure	Dose Regimen A (DR-A) Escalation n = 41	Dose Regimen B (DR-B) Escalation n = 30
Value	3.1	NA

Primary outcome: Determine Overall Response Rate

Measure	Dose Regimen A (DR-A) PTCL Expansion n = 21	Dose Regimen C (DR-C) PTCL Expansion n = 16
Value	2	2

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Dose Regimen A (DR-A) Escalation (1.25 mg/kg)	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Dose Regimen A (DR-A) Escalation (2.1 mg/kg)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Dose Regimen A (DR-A) Escalation (3.1 mg/kg)	2 of 9 (22.2%)	9 of 9 (100%)	0 of 9
Dose Regimen A (DR-A) Escalation (4.4 mg/kg)	4 of 11 (36.4%)	11 of 11 (100%)	0 of 11
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)	1 of 5 (20%)	5 of 5 (100%)	0 of 5
Dose Regimen B (DR-B) Escalation (0.8 mg/kg)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Dose Regimen B (DR-B) Escalation (1.1 mg/kg)	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Dose Regimen B (DR-B) Escalation (1.5 mg/kg)	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Dose Regimen B (DR-B) Escalation (2.0 mg/kg)	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Dose Regimen B (DR-B) Escalation (2.7 mg/kg)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Dose Regimen A (DR-A) PTCL Expansion	7 of 21 (33.3%)	19 of 21 (90.5%)	0 of 21
Dose Regimen C (DR-C) PTCL Expansion	7 of 16 (43.8%)	15 of 16 (93.8%)	0 of 16
Combination With Palbociclib Expansion	5 of 34 (14.7%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34230007Zhou X, Singh M, Sanz Santos G, Guerlavais V, Carvajal LA, Aivado M, Zhan Y, Oliveira MMS, Westerberg LS, Annis DA, Johnsen JI, Selivanova G. Pharmacologic Activation of p53 Triggers Viral Mimicry Response Thereby Abolishing Tumor Immune Evasion and Promoting Antitumor Immunity. Cancer Discov. 2021 Dec 1;11(12):3090-3105. doi: 10.1158/2159-8290.CD-20-1741.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ALRN-6924 in people with Solid Tumor and Lymphoma, run by Aileron Therapeutics, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02264613, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.