Stan rekrutacji pochodzi z rejestrów badań i może się zmienić szybciej, niż zaktualizuje go sponsor. Nasz doradca sprawdzi aktualny stan w wybranym ośrodku. Nie publikujemy nazwisk lekarzy ani ich danych kontaktowych.
Cel badania
Opis z rejestru (w języku angielskim):
This is a study evaluating the safety, pharmacokinetics, and efficacy of calderasib alone, and calderasib plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.
Leczenie w badaniu
Lek / interwencja
Rola
Postać, podanie
Calderasib
Lek
Pembrolizumab
Lek biologiczny
carboplatin
Lek
pemetrexed
Lek
cetuximab
Lek biologiczny
oxaliplatin
Lek
leucovorin
Lek
5-fluorouracil
Lek
Kryteria udziału
Kryteria w języku angielskim, tak jak w rejestrze.
Kryteria włączenia kto może wziąć udział (11)
For all participants:
Has measurable disease by RECIST 1.1 criteria
Has adequate organ function
Male participants agree to protocol-specified contraception requirements including refraining from donating sperm and using protocol-specified contraceptives unless confirmed to be azoospermic
Female participants must not be pregnant or breastfeeding, and must agree to protocol-specified contraceptive requirements and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
For Arm 2
- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%
For Arm 3
Has locally advanced unresectable or metastatic solid-tumor malignancy with histological or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 2L+NSCLC
Has histologically or cytologically confirmed diagnosis of unresectable or metastatic NSCLC with histological or blood-based confirmation of KRAS G12C mutation and submits archival tumor sample
Previous treatment failure of at least 1 line of systemic therapy Expansion Group B
Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation
Arm 5 only
Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation
Previous treatment failure of one or 2 previous line(s) of systemic therapy
Arm 6 only
- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation
Kryteria wyłączenia kto nie może wziąć udziału (12)
Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention
Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active infection requiring systemic therapy
Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection
Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis
Has an active autoimmune disease requiring systemic therapy
Has not fully recovered from any effects of major surgical procedure without significant detectable infection
Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease excluding age-related macular degeneration
Has received live or live-attenuated vaccine within 4 weeks of study start
Arm 4 Only
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed.
Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
To główne kryteria z rejestru. Pełną listę i ostateczną decyzję o udziale ustala lekarz prowadzący badanie.
Zapytaj o udział w tym badaniu
Zadzwoń, a nasz doradca ds. badań sprawdzi z Tobą wstępnie kryteria i pomoże skontaktować się z ośrodkiem. Kwalifikację zawsze przeprowadza lekarz w ośrodku. Udział w badaniu jest bezpłatny i dobrowolny.
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Informacje pochodzą z publicznych rejestrów badań klinicznych (CTIS - Unia Europejska, ClinicalTrials.gov - USA) i są aktualizowane codziennie. Mogą różnić się od aktualnego stanu w ośrodku. Ostateczną kwalifikację do badania zawsze przeprowadza lekarz w ośrodku badawczym. Stan na 2 października 2026.
+11
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