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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05538130 | A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors | PHASE1 | RECRUITING | 124 | — | — | Nov 30, 2022 | Jun 18, 2029 | Jun 5, 2026 | 83 | United States, Australia +5 |
DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation)
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.
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
| Arm | Type | Description |
|---|---|---|
| Phase 1a Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive PF-07799544 |
| Phase 1b Combination Dose Escalation | EXPERIMENTAL | Participants will receive PF-07799544 and PF-07799933 |
| Phase 1b Combination Dose Expansion | EXPERIMENTAL | Participants will receive PF-07799544 and PF-07799933 |
| Name | Type | Description |
|---|---|---|
| PF-07799544 | DRUG | Tablet |
| PF-07799933 | DRUG | Tablet |
Phase 1b Inclusion Criteria: * Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer) * Measurable disease by RECIST version 1.1 * Evidence of a BRAF V600 mutation * Prior therapy per tumor cohort * Adequate organ function per protocol Phase 1b Exclusion Criteria: * Other acti...