Title |
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 |
ClinicalTrials.gov ID |
NCT05538130 |
Cancer Type(s) |
Solid Tumors |
Phase |
Phase I |
Stage |
|
Study Type |
Clinical |
Drug |
PF-07799544 |
Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
City |
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Principal Investigator |
Dr. Ramy Saleh
|
Coordinator |
Abdul-Rahman El-Hassan
514-934-1934 poste 35161
|
Status |
Recruiting |
Activation Date |
14-02-2024 |
Eligibility Criteria |
- 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
|
Exclusion Criteria |
- 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)
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