Status:
COMPLETED
ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas
Lead Sponsor:
Aileron Therapeutics, Inc.
Conditions:
Solid Tumor
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with WT TP53.
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 wit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT02264613
Start Date
October 1 2014
End Date
April 1 2020
Last Update
July 14 2020
Active Locations (13)
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1
Birmingham, Alabama, United States, 35294
2
Duarte, California, United States, 91010
3
Denver, Colorado, United States, 80218
4
Sarasota, Florida, United States, 34232