INCB161734-101 - A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Studio Clinico

Patologia: Carcinoma del pancreas esocrino, Neoplasie del polmone, Tumori del colon retto, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1,

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- ≥18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Locally-advanced or metastatic solid tumor with KRAS G12D mutation
- For Part 1 and Part 2 Combination Groups 1 and 2: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment to improve the disease outcome
- For Part 2 Combination Groups 3 and 4: No more than 1 prior standard treatment
Cohort specific requirements as follows:
    - Parts 1A and 1D: Histologically or cytologically confirmed malignant solid tumor of any tissue origin
    - Part 1B
        - Disease group 1: diagnosis of PDAC and ≤ 2 prior standard systemic regimens for pancreatic cancer
        - Disease group 2: diagnosis of CRC
        - Disease group 3: diagnosis of NSCLC
        - Disease group 4: diagnosis of other advanced solid tumor and not part of Disease groups 1, 2 or 3
    - Part 1c: Confirmed diagnosis of PDAC, CRC, or NSCLC
    - Parts 2A and 2B
        - Combination 1: Diagnosis of PDAC or Diagnosis of CRC and
            - Prior treatment in the advanced setting with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan and
            - In Part 2a: ≤ 3 prior standard regimens
            - In Part 2b: ≤ 2 prior standard regimens
        - Combination 2: Diagnoses of PDAC, CRC or NSCLC
        - Combination Group 3 (INCB161734 in combination with GEMNabP) and Combination Group 4 (INCB161734 in combination with mFOLFIRINOX):
            - Diagnosis of PDAC
            - ≤ 1 prior standard systemic regimen for pancreatic cancer'

Criteri di esclusione: 

- Prior treatment with any KRAS G12D inhibitor
- Known additional invasive malignancy within 1 year of the first dose of study drug
- History of organ transplant, including allogeneic stem cell transplantation
- Significant, uncontrolled medical condition
- History or presence of an ECG abnormality
- Inadequate organ function.

Trattamento sperimentale: 

INCB161734

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-507091-47-00

Data di inserimento: 12.03.2025

Promotore

Incyte Corporation

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na