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A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement

Status
Active
Cancer Type
Lung Cancer
Melanoma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04543188
Protocol IDs
C4471001 (primary)
NCI-2020-08201
Study Sponsor
Pfizer Inc

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

  1. Age =18 years at the time of consent
  2. Histologically confirmed diagnosis of advanced/metastatic solid tumor including primary brain tumor
  3. Documented evidence of a BRAF V600 mutation in tumor tissue or blood
  4. Confirmation of availability of adequate tumor tissue for submission to the sponsor/central laboratory
  5. Presence or absence of brain involvement unless specified below
  6. Dose Expansion (Part B)
  7. Cohort 1, 2, 3, 4: melanoma or NSCLC with at least 1 parenchymal brain lesion
  8. Cohort 1,3: asymptomatic in the brain for at least 14 days prior to start of study treatment
  9. Cohort 2,4: symptomatic in the brain within 14 days prior to the start of study treatment
  10. Cohort 5: any solid tumor that does not meet requirements for Cohorts 1-4, history of or current leptomeningeal metastases.
  11. Cohort 6 (DDI Sub-study): if brain involvement present, must be asymptomatic
  12. Disease progression despite prior treatment and no acceptable alternative treatment options available unless specified below
  13. Dose Expansion (Part B)
  14. Cohort 1, 2: No prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of study treatment
  15. Cohort 3, 4: Required prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of treatment
  16. 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.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.