Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05355701 | A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. | PHASE1 | RECRUITING | 267 | — | — | Jul 5, 2022 | Oct 25, 2029 | Jun 5, 2026 | 40 | United States, Canada +1 |
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...