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ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria.

  • - 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.
Key Exclusion Criteria.
  • - 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.
  • - HPV positive tumors.
  • - Second malignancy within two years, with protocol specified exceptions.
- Pregnancy or lactation

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02264613
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Aileron Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Solid Tumor, Lymphoma, Peripheral T-Cell Lymphoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Dose Regimen A (DR-A)

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

Experimental: Dose Regimen B (DR-B)

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

Experimental: Dose Regimen C (DR-C)

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

Experimental: Combination with palbociclib

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

Interventions

Drug: - ALRN-6924

ALRN-6924 will be administered as an IV infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duarte, California

Status

Address

Duarte, California, 91010

Denver, Colorado

Status

Address

Denver, Colorado, 80218

Sarasota, Florida

Status

Address

Sarasota, Florida, 34232

Tampa, Florida

Status

Address

Tampa, Florida, 33612

Boston, Massachusetts

Status

Address

Boston, Massachusetts, 02114

Boston, Massachusetts

Status

Address

Boston, Massachusetts, 02215

Bronx, New York

Status

Address

Bronx, New York, 10461

New York, New York

Status

Address

New York, New York, 10065

Greenville, South Carolina

Status

Address

Greenville, South Carolina, 29605

Nashville, Tennessee

Status

Address

Nashville, Tennessee, 37203

Houston, Texas

Status

Address

Houston, Texas, 77030

Seattle, Washington

Status

Address

Seattle, Washington, 98105

Birmingham, Alabama

Status

Address

Birmingham, Alabama, 35294

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