A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement
16 Years and older, Male and Female
C4471001 (primary)
NCI-2020-08201
Summary
First-in-human study to assess safety, tolerability, PK, and preliminary activity of
PF-07284890 as a single agent and in combination with binimetinib in participants with BRAF
V600-mutated advanced solid tumor malignancies with and without brain involvement.
Eligibility
- Age =16 years at the time of consent
- Histologically confirmed diagnosis of advanced/metastatic solid tumor including primary brain tumor
- Documented evidence of a BRAF V600 mutation in tumor tissue or blood
- Confirmation of availability of adequate tumor tissue for submission to the sponsor/central laboratory
- Presence or absence of brain involvement unless specified below
- Dose Expansion (Part B)
- Cohort 1, 2, 3, 4: melanoma with at least 1 parenchymal brain lesion
- Cohort 1,3: asymptomatic in the brain for at least 14 days prior to start of study treatment
- Cohort 2,4: symptomatic in the brain within 14 days prior to the start of study treatment
- Cohort 5: any solid tumor that does not meet requirements for Cohorts 1-4, history of or current leptomeningeal metastases.
- Optional Cohort 6 (DDI Sub-study) and 7 (Food-Effect): if brain involvement present, must be asymptomatic
- Disease progression despite prior treatment and no acceptable alternative treatment options available unless specified below
- Dose Expansion (Part B)
- Cohort 1, 2: No prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of study treatment
- Cohort 3, 4: Required prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.