| TITRE |
(EN) A phase 1A/B open-label master study of PF-07799544 as a single-agent and in combination with other targeted agents in participants with advanced solid tumors |
| PROTOCOLE ID |
C4901001 |
| CLINICAL TRIAL.gov ID |
NCT05538130 |
| TYPE(S) DE CANCER |
Prostate |
| PHASE |
Phase I |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Ramy Saleh
|
| COORDONATEUR(RICE) |
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation
- Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation
- For Substudy A and B, histological or cytological diagnosis of advanced/metastatic melanoma
- For Substudy A and B, measurable disease by RECIST version 1.1
- For Substudy A, evidence of a BRAF V600 mutation in tumor tissue and/or blood
- For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II alteration in tumor tissue and/or blood
|
| CRITÈRES D'EXCLUSION |
(EN)
- Brain metastasis larger than 4 cm
- Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
- For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
|
