Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 studied for use in advanced solid tumors with BRAF alterations, including melanoma, non-small-cell lung cancer, thyroid cancer, glioma, and advanced colorectal cancer. It is also being studied in healthy volunteers for pharmacokinetic purposes. The drug is in Phase 1 clinical development.
PF-07799933 is being studied in patients with BRAF alterations, indicating it targets the BRAF pathway. It is designed for advanced solid tumors that harbor these genetic changes. The drug is in Phase 1 trials to evaluate its safety and efficacy in this patient population.
PF-07799933 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for advanced solid tumors with BRAF alterations.
PF-07799933 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied in patients with advanced solid tumors with BRAF alterations and in healthy volunteers for pharmacokinetic assessments.
PF-07799933 is being studied in two Phase 1 clinical trials. NCT05355701 is an active, not recruiting study in patients with advanced solid tumors with BRAF alterations, including melanoma, non-small-cell lung cancer, thyroid cancer, glioma, and advanced colorectal cancer. NCT07563894 is a completed study in healthy volunteers.
PF-07799933 and PF-07799544 are distinct investigational compounds. They are being studied together in a clinical trial (NCT07563894) to assess the relative bioavailability of PF-07799933 and the impact of rabeprazole and food on both drugs. They are not the same drug.