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GCT1042-01 - A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors

Studio Clinico

Patologia: Carcinoma del pancreas esocrino, Melanoma, Neoplasie del polmone, Tumori del colon retto, Tumori della testa e del collo

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, II

Linee di trattamento: Prima linea

Criteri di inclusione: 

Monotherapy - Dose Escalation and Dose Expansion Part
    - Subjects with non-CNS solid tumors that is metastatic or unresectable and for whom there is no available standard therapy.
    - Subjects with a confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC and for whom there is no available standard therapy

Combination Therapy - Dose Expansion Part
    - Subjects with unresectable Stage III or Stage IV melanoma with no prior systemic anticancer therapy for unresectable or metastatic disease. Primary ocular or mucosal melanoma is excluded.
    - Subjects with Stage IV metastatic or recurrent NSCLC with no prior systemic anticancer therapy, no actionable mutation.
    - Subjects with recurrent or metastatic HNSCC with no prior systemic therapy administered in the recurrent or metastatic setting.
    - Subjects with confirmed metastatic PDAC with no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.

General (all phases):
    - Must be age ≥ 18 years of age on the day of signing informed consent, or the legal age of consent in the jurisdiction in which the trial is taking place.
   - Measurable disease according to RECIST 1.1
    - Eastern Cooperative Oncology Group (ECOG) 0-1
    - Normal or adequate liver, renal, cardiac and bone marrow function.

Criteri di esclusione: 

Monotherapy - Dose Escalation and Dose Expansion Parts
    - Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1042 administration
    - Radiotherapy within 14 days prior to first GEN1042 administration
    - Toxicities from previous anti-cancer therapies that have not resolved

Combination Therapy - Dose Expansion Part
    - Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major surgery within 3 weeks or at least 5 half-lives of the drug (whichever is shorter) of the first dose of trial treatment.
    - Radiotherapy within 14 days of start of trial treatment or received lung radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment.

General (all phases)
    - Subject has an active, known, or suspected autoimmune disease.
    - History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
    - History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
    - Subject with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trattamento sperimentale: 

Monotherapy - Dose Escalation and Dose Expansion parts
Escalating doses of GEN1042 monotherapy in subjects with non-central nervous system (CNS) solid malignant tumors followed by monotherapy expansion cohorts at selected dose(s) in subjects with relapsed or refractory, advanced and/or metastatic melanoma, or non-small-cell lung cancer (NSCLC), or colorectal cancer (CRC).

Combination Therapy - Dose Expansion Part
GEN1042 safety and efficacy will be evaluated in combination with pembrolizumab with or without chemotherapy in treatment-naive subjects with advanced or metastatic melanoma, non-small-cell lung cancer [NSCLC], head and neck squamous cell carcinoma [HNSCC], and pancreatic cancer.

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Azienda Ospedaliera S. Croce e Carle di Cuneo
Via Michele Coppino 26 - 12100 Cuneo - CN

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
SC Oncologia Medica 3 - Tumori Testa Collo

Riferimento: Prof.ssa Lisa Licitra
Telefono: 0223903352
Email: lisa.licitra@istitutotumori.mi.it

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Prof. Armando Santoro
Email: armando.santoro@cancercenter.humanitas.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-003716-47 - NCT04083599

Data di inserimento: 11.03.2024

Promotore

Genmab

Principal Investigator ITALIA

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Riferimento: Prof.ssa Lisa Licitra

Telefono: 0223903352

Email: lisa.licitra@istitutotumori.mi.it

Localita: Milano

 

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