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C6461020 - An Interventional Open-Label Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of PF-08634404 in combination with Different Anticancer Agents in Participants with Advanced Solid Tumors

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523526-40-00
Enrollment
43
Registered
2026-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

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

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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.

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 11, 2026