22676 - Phase 1 Study of a SOS1 Inhibitor, BAY 3498264, in Combination in Participants With Advanced KRASG12C-mutated Solid Tumors

Studio Clinico

Patologia: Carcinoma del pancreas esocrino, Carcinoma della vescica, Neoplasie del polmone, Tumori del colon retto, Tumori dell’utero, Tumori dell’ovaio, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1,

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Histologically confirmed solid tumor malignancy with documented KRASG12C mutation as assessed by an appropriately accredited laboratory.
- Documented disease progression after treatment with at least 1 prior standard of care (SoC) systemic therapy other than a G12C inhibitor for locally advanced or metastatic disease, and with no further standard treatment options available, or when standard treatment options are not acceptable and this study is a reasonable option.
    - Participants whose access to SoC therapies is limited due to regional access, refusal, intolerance, or eligibility may participate.
    - Prior G12C inhibitor treatment is permitted. Participants receiving prior G12C inhibitor therapy must have documented disease progression after treatment, or have discontinued that treatment due to intolerance.
- Adequate archival formalin-fixed paraffin-embedded tumor tissue available (preferably no older than 6 months, obtained after the last targeted therapy). If archival material is not available, a fresh tumor biopsy should ideally be obtained if safe and feasible.
- Eastern Cooperative Oncology Group (ECOG) of 0 to 2 and life expectancy of at least 12 weeks.

Criteri di esclusione: 

- Active central nervous system (CNS) tumors including metastatic brain disease, at the time of screening.
    - 'Active' is defined as untreated brain lesions (new or progressing) or symptomatic brain lesions (as determined by the investigator)
    - Participants who have received treatment (e.g. surgery or radiotherapy) for brain metastases ending at least 4 weeks before cycle 1 day 1 (C1D1) may be eligible if, at the point of study entry:
        i. their condition is considered stable by the investigator
        ii. they have no residual neurological symptoms (Grade >2)
        iii. a follow-up Magnetic resonance imaging (MRI) scan during the screening period shows no progression or new lesions
        iv. they do not need systemic corticosteroids to treat symptoms of brain metastasis
- Any grade active pneumonitis or interstitial lung disease (ILD), or past medical history of:
    - Grade ≥2 ILD,
    - Drug-induced ILD
    - Radiation pneumonitis that required steroid treatment within the last 12 months
- Additional malignancy within the past 3 years, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, in agreement with the Sponsor, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study.
- Any positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating the presence of virus.
    - Active HBV (chronic or acute; defined as having a known positive HBsAg test at the time of screening) except for participants on antiviral therapy for HBV with an undetectable or low viral load.
    - Participants with past HBV infection or resolved HBV infection (defined as the presence of HBcAb and absence of HBsAg) are eligible if HBV DNA is negative.
    - Participants positive for HCV antibody unless polymerase chain reaction is negative for HCV RNA. Any prior antiviral therapy must be completed at least 28 days before the first dose of study intervention.

Schema di trattamento: 

During the study, participants will receive the following treatments:

- BAY3498264: participants will first receive BAY3498264 alone for seven days and then BAY3498264 in combination with sotorasib. These combination treatments will be given in cycles, each lasting 21 days.
- Sotorasib: participants will receive a standard, approved dose of Sotorasib once every day with BAY3498264.

Trattamento sperimentale: 

BAY3498264 (oral)

Trattamento di controllo: 

-

Obiettivi primari dello studio: 

The main purpose of this first-in-human study is to learn how safe BAY3498264 is when given together with sotorasib and what is the maximum dose of BAY3498264 that can be safely given to participants together with sotorasib.

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-513300-34-00 - NCT06659341

Data di inserimento: 19.11.2024

Promotore

Bayer

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na