Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ARRY-440
PF-07799933 · 1 trial · 5 indications
DLTs will be evaluated during the first cycle (21 days) as both a single agent or in combination with binimetinib or cetuximab
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Laboratory abnormalities as characterized by type, frequency, severity, and timing
Vital sign abnormalities as characterized by type, frequency, severity, and timing
Incidence of dose interruptions due to AEs
Incidence of dose modifications due to AEs
Incidence of discontinuations due to AEs
Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
| Arm | Type | Description |
|---|---|---|
| Monotherapy dose escalation (Part 1) | EXPERIMENTAL | Participants will receive PF-07799933 |
| Combination dose escalation (Part 2) | EXPERIMENTAL | Participants will receive PF-07799933 in combination with binimetinib or cetuximab |
| Dose expansion (Part 3) - Tumor and mutation specific Cohort 1 | EXPERIMENTAL | Participants will receive PF-07799933 |
| Dose expansion (Part 3) - Tumor and mutation specific Cohort 2 | EXPERIMENTAL | Participants will receive PF-07799933 |
| Dose expansion (Part 3) - Tumor and mutation specific Cohort 3 | EXPERIMENTAL | Participants will receive PF-07799933 |
| Dose expansion (Part 3) - Tumor and mutation specific Cohort 4 | EXPERIMENTAL | Participants will receive PF-07799933 in combination with cetuximab |
| Dose expansion (Part 3) - Tumor and mutation specific Cohort 5 | EXPERIMENTAL | Participants will receive PF-07799933 in combination with cetuximab and mFOLFOX6 regimen |
| Dose expansion (Part 3) - Tumor and mutation specific Cohort 6 | EXPERIMENTAL | Participants will receive PF-07799933 |
| Dose expansion (Part 3) - Tumor and mutation specific Cohort 7 | EXPERIMENTAL | Participants will receive PF-07799933 |
| Name | Type | Description |
|---|---|---|
| PF-07799933 | DRUG | Tablet |
| binimetinib | DRUG | Tablet |
| cetuximab | BIOLOGICAL | Injection for intravenous use |
| midazolam | DRUG | syrup |
| fluorouracil | DRUG | Injection for intravenous use |
| leucovorin | DRUG | Injection for intravenous use |
| oxaliplatin | DRUG | Injection for intravenous use |
This study is seeking participants who meet the following key eligibility criteria: Inclusion Criteria: * Diagnosis of advanced/metastatic solid tumor including primary brain tumor. * Qualifying BRAF alteration (V600 or non-V600 Class II/Class III BRAF alteration), in tumor tissue and/or blood (ie...
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PF-07799933 is an investigational small molecule being developed by Pfizer, Inc. (ticker: PFE) for the treatment of advanced solid tumors with BRAF alterations, including melanoma. It is currently in Phase 1 clinical development and is not approved for any indication.
PF-07799933 is being studied for use in patients with advanced solid tumors that have BRAF alterations, including melanoma. It is an investigational therapy and has not been approved for the treatment of melanoma or any other condition.
PF-07799933 is developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the sponsor of the clinical trial evaluating this investigational small molecule in patients with BRAF-altered advanced solid tumors.
PF-07799933 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency for any indication.
PF-07799933 is being evaluated in a Phase 1 trial, NCT05355701, titled "A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations." The trial is active but not recruiting and has enrolled 103 participants across the United States, Canada, and Israel.