ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas
This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with WT TP53.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02264613.
Locations matching your search criteria
United States
New York
New York
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.
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationAileron Therapeutics, Inc.
- Primary IDALRN-6924-1-01
- Secondary IDsNCI-2015-00008, ALRN-200-01
- ClinicalTrials.gov IDNCT02264613