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PYNNACLE - A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation

Studio Clinico

Patologia: Neoplasie della mammella, Neoplasie del polmone, Tumori dell’utero, Tumori dell’ovaio, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval
- Advanced 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
- Adequate organ function
- Measurable disease per RECIST v1.1 (Phase 2)

Additional Criteria for Inclusion in Phase 1b (PC14586 (INN: rezatapopt) + pembrolizumab combination)

- Anti-PD-1/PD-L1 naive or must have progressed on treatment
- Measurable disease.

Criteri di esclusione: 

- Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug
- Radiotherapy within 28 days of receiving the study drug
- Primary CNS tumor
- History of leptomeningeal disease or spinal cord compression
- Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms
- Stroke or transient ischemic attack within 6 months prior to screening
- Heart conditions such as unstable angina, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities
- Strong CYP3A4 inhibitors or inducers, medications with a known risk of QT/QTc prolongation, or proton pump inhibitors
- History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication
- History of prior organ transplant
- Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer
- Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection

Additional Criteria for Exclusion from Phase 2 (PC14586 monotherapy)
- Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)

Additional Criteria for Exclusion from Phase 1b (PC14586 (INN: rezatapopt) + pembrolizumab combination)
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)
- Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention
- Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug
- Hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
- Active autoimmune disease that has required systemic treatment in past 2 years
- History of radiation pneumonitis
- History of (non-infectious) or active pneumonitis / interstitial lung disease that required steroids
- Active infection requiring systemic therapy
- Known history of HIV infection
- Has previously received PC14586 (INN: rezatapopt).

Trattamento sperimentale: 

PC14586

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Grande Ospedale Metropolitano Niguarda
Piazza Ospedale Maggiore 3 - 20162 Milano - MI

Riferimento: Prof. Salvatore Siena
Telefono: 0264442291
Email: oncologia@ospedaleniguarda.it

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
S.S. Immunoterapia clinica dei tumori e terapie innovative

Telefono: 0223902506

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
Contatti: Dott. Matteo Simonelli (matteo.simonelli@hunimed.eu); Dott.ssa Agnese Losurdo (agnese.losurdo@humanitas.it); Dott. Pasquale Persico (pasquale.persico@humanitas.it); Dott. Angelo Dipasquale (angelo.dipasquale@humanitas.it)

Telefono: 0282248224

 

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO

 

Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

Riferimento: Prof. Giovanni Scambia
Telefono: 0630154979
Email: giovanni.scambia@policlinicogemelli.it

 

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM

Riferimento: Dr.ssa Lorenza Landi
Email: lorenza.landi@ifo.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-504251-27-00 - NCT04585750

Data di inserimento: 15.11.2024

Promotore

PMV Pharmaceuticals, Inc

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na

 

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