Trial summary: This study will investigate whether calderasib (KRASG12C inhibitor) given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation.
Status: OPEN - Recruiting
Trial identifier: NCT07209111
Sponsor: MSD
Phase: II
Diagnosis: Locally advanced (Stage III) unresectable or Metastatic (Stage IV) pancreatic ductal adenocarcinoma.
Line of therapy: Second-line and beyond
Treatment: Calderasib (MK-1084; oral KRASG12C covalent inhibitor) +/- Cetuximab (IV).
  • Key inclusion criteria

    The main inclusion criteria include but are not limited to the following:

    1. Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
    2. Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation
  • Key exclusion criteria

    The main exclusion criteria include but are not limited to the following:

    1. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
    2. Has known additional malignancy that is progressing or has required active treatment within the past 3 years
    3. Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
    4. Has active infection, other than those permitted per protocol, requiring systemic therapy
    5. Has not adequately recovered from major surgery or has ongoing surgical complications

KANDLELIT

Locations: Epworth Richmond, Epworth Freemasons (East Melbourne), Epworth Eastern (Box Hill)

Epworth PI: A/Prof Sumitra Ananda

Jreissati Pancreatic Centre at Epworth 

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