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Trial details

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

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Trial short name: ARRY-134

Official 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

Principal Investigator: Dr. Rossanna Pezo

Cancer type: Melanoma
Cancer location: Melanoma
Disease stage: Early Cancer
Trial phase: Phase 1
Intervention: Drug: PF-07799544 Drug: PF-07284890 Drug: PF-07799933 Drug: encorafenib

Registration #: NCT05538130

Contact e-mail: cancerclinicaltrials@sunnybrook.ca

Trial description:
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) administered as a single agent and in combination with other study medications in people with solid tumors. This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799544. PF-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this could change to once daily or another frequency). Depending on the part of the study, participants may also receive another study medicine. • In the first part of the study, people with melanoma or other solid tumors may also receive encorafenib. Encorafenib comes as a capsule and is taken once per day. • In the second part of the study, people with melanoma with a certain type of abnormal gene called "BRAF" will receive PF-07799544 with other study medicines (for example, PF-07284890 or PF-07799933). Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Inclusion 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)