Advanced Solid Tumors
Conditions
Brief summary
Phase 1 Safety Run-In: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention., DLTs., Phase 2 Dose Optimization and Dose Expansion: Confirmed ORR per RECIST v1.1 by investigator, AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Detailed description
Phase 1 Safety Run-In: Confirmed ORR per RECIST v1.1 by investigator, DCR per RECIST v1.1 by investigator, DOR per RECIST v1.1 by investigator, PFS per RECIST v1.1 by investigator, OS, Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing., Predose and/or postdose concentrations of PF-08634404, SV, and PF-08046054., Incidence of ADA against PF-08634404, SV, and PF-08046054., Phase 2 Dose Optimization and Dose Expansion: DOR per RECIST v1.1 by investigator, DCR per RECIST v1.1 by investigator, PFS per RECIST v1.1 by investigator, OS, Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing., Predose and/or postdose concentrations of PF-08634404, SV, and PF-08046054., Incidence of ADA against PF-08634404, SV, and PF-08046054.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 Safety Run-In: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention., DLTs., Phase 2 Dose Optimization and Dose Expansion: Confirmed ORR per RECIST v1.1 by investigator, AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1 Safety Run-In: Confirmed ORR per RECIST v1.1 by investigator, DCR per RECIST v1.1 by investigator, DOR per RECIST v1.1 by investigator, PFS per RECIST v1.1 by investigator, OS, Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing., Predose and/or postdose concentrations of PF-08634404, SV, and PF-08046054., Incidence of ADA against PF-08634404, SV, and PF-08046054., Phase 2 Dose Optimization and Dose Expansion: DOR per RECIST v1.1 by investigator, DCR per RECIST v1.1 by investigator, PFS per RECIST v1.1 by investigator, OS, Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing., Predose and/or postdose concentrations of PF-08634404, SV, and PF-08046054., Incidence of ADA against PF-08634404, SV, and PF-08046054. | — |