| TITRE |
(EN) A Multicenter, Open Label, Non-randomized First-in-human Phase 1 Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BAY 3547926 Alone, and in Combination, in Participants With Advanced Hepatocellular Carcinoma (HCC) |
| PROTOCOLE ID |
BANTAM-01 |
| CLINICAL TRIAL.gov ID |
NCT06764316 |
| TYPE(S) DE CANCER |
Foie |
| PHASE |
Phase I |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CHUS
3001 12e Avenue Nord
(819) 346-1110
|
| VILLE |
Sherbrooke
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Frédéric Lemay
|
| COORDONATEUR(RICE) |
Christine Lawson
christine.lawson.ciussse-chus@ssss.gouv.qc.ca
819-346-1110 poste 12942
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Locally advanced or metastatic and/or unresectable HCC (hepatocellular carcinoma) with histological or cytological confirmation, or non-invasive diagnosis as per American Association for the Study of Liver Diseases (AASLD) criteria in participants with a confirmed diagnosis of cirrhosis.
- Demonstrated positive centrally confirmed GPC3 expression by immunohistochemistry (IHC) on tumor sample.
- Disease not amenable to, or progressive disease after, curative surgery and/or locoregional therapies of established efficacy such as resection, local ablation, chemoembolization.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- At least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. as assessed by local site Investigator within 28 days prior to the start of the study treatment.
- Adequate bone marrow and organ function
|
| CRITÈRES D'EXCLUSION |
(EN)
- Fibrolamellar HCC, sarcomatoid HCC, and mixed hepatocellular/cholangiocarcinoma subtypes.
- Participants with a history or clinical evidence of CNS metastases, unless they meet specific criteria
- History of encephalopathy ≥ Grade 2 within the past 12 months
- Clinically significant ascites
|
