Health Trials

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

ConditionsAdvanced Solid TumorAdvanced Malignant NeoplasmMetastatic CancerMetastatic Solid TumorLung CancerOvarian CancerEndometrial CancerProstate CancerColorectal CancerBreast CancerOther CancerLocally AdvancedHead and Neck CancerGall Bladder CancerSmall Cell Lung CancerSmall Cell Lung Cancer ( SCLC )Small Cell Lung CarcinomaNSCLCNSCLC (Non-small Cell Lung Cancer)SCLCNon-Small Cell Lung CarcinomaTriple Negative Breast CancerTNBCHER2+ Breast CancerNon-Small Cell Lung CancerER/PR Positive Breast CancerHER2- Breast CancerHER2-positive Breast CancerHER2-negative Breast CancerER/PR(+), Her2(-) Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorPMV Pharmaceuticals, Inc

About this trial

The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.

Eligibility criteria

Qualifiers

At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.

Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation

Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

Previously treated with one or more lines of anticancer therapy and progressive disease

Disqualifiers

Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug

Radiotherapy within 14 days of receiving the study drug

Primary CNS tumor

History of leptomeningeal disease or spinal cord compression

Trial design

Treatments tested in this trial

  • rezatapopt
  • pembrolizumab

Treatment groups

300 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Locations

77
Australia
Chris O'Brien Lifehouse Hospital CamperdownNew South Wales, Australia
Mater Cancer Care Centre South BrisbaneQueensland, Australia
Flinders Medical Center Bedford ParkSouth Australia, Australia
Monash Medical Centre ClaytonVictoria, Australia

Sponsors and collaborators

PMV Pharmaceuticals, Inc

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov