Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma
Conditions
Brief summary
Phase 1b (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/Expansion): Confirmed ORR per RECIST 1.1 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 1b (Safety Run-In): Confirmed ORR per RECIST 1.1 by investigator, DOR per RECIST 1.1 by investigator, PFS per RECIST 1.1 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, Incidence of ADA against PF-08634404, Phase 2 (Dose Optimization/Expansion): DOR per RECIST 1.1 by investigator, PFS per RECIST 1.1 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., Incidence of ADA against PF-08634404.
Interventions
DRUGPF-08634404
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1b (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/Expansion): Confirmed ORR per RECIST 1.1 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 1b (Safety Run-In): Confirmed ORR per RECIST 1.1 by investigator, DOR per RECIST 1.1 by investigator, PFS per RECIST 1.1 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, Incidence of ADA against PF-08634404, Phase 2 (Dose Optimization/Expansion): DOR per RECIST 1.1 by investigator, PFS per RECIST 1.1 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., Incidence of ADA against PF-08634404. | — |
Outcome results
None listed