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

Status
Active
Cancer Type
Lymphoma
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT02264613
Protocol IDs
ALRN-6924-1-01 (primary)
NCI-2015-00008
ALRN-200-01
Study Sponsor
Aileron Therapeutics

Summary

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

Objectives

Open label, multi-center dose escalation (DEP) and dose expansion (EXP) study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with wild-type (WT) TP53. ALRN-6924 is a stapled peptide designed to disrupt integration between the p53 tumor suppression protein and inhibition by murine double minute 2 (MDM2) and murine double minute X (MDMX). The DEP 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 can be enrolled.The EXP portion of the study 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 at the MTD or OBD. PTCL has been selected as one of the EXP groups to be further studied. Treatment of patients in the DEP and EXP phases will continue in the study until documentation of disease progression, unacceptable toxicity, or patient or physician decision to discontinue study participation is made.
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