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C4891023 - TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471 /PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY B (ARV-471 IN COMBINATION WITH RIBOCICLIB)

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502231-19-00
Acronym
C4891023
Enrollment
18
Registered
2023-08-14
Start date
2024-01-02
Completion date
Unknown
Last updated
2025-03-13

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

Conditions

ER+/HER2- Advanced or Metastatic Breast Cancer

Brief summary

Phase 1b: DLTs during DLT observation period (Cycle 1)., Fase 2: Confirmed OR (CR or PR) determined by investigator assessment., DDI Assessment Cohort(s): Steady-state AUCtau and Cmax of ribociclib with and without co-administration of ARV-471.

Detailed description

Phase 1b and Phase 2: AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to ARV-471 in combination with ribociclib. •Laboratory test abnormalities as characterized by type, frequency, intensity (as graded by NCI CTCAE version 5.0), and timing., Fase 1b: Confirmed OR (CR or PR) by investigator assessment. · DoR by investigator assessment. · CBR (confirmed CR or PR at any time, or SD ≥24 weeks) by investigator assessment. · PFS by investigator assessment. Phase 2: DoR by investigator assessment. · CBR (confirmed CR or PR at any time or SD ≥24 weeks) by investigator assessment. · PFS by investigator assessment. · OS., Phase 1b and Phase 2: Plasma concentrations of ARV-471, ARV-473, and ribociclib., Phase 1b: AUCtau and Cmax of ARV-471 with and without co-administration of ribociclib., Phase 2: ctDNA plasma quantitative changes from pre-treatment to evaluate potential predictability of their associations with clinical outcomes., DDI Assessment Cohort(s): - Incidence of AEs and SAEs. - Incidence of laboratory abnormalities. - Incidence of ECG abnormalities.

Interventions

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase 1b: DLTs during DLT observation period (Cycle 1)., Fase 2: Confirmed OR (CR or PR) determined by investigator assessment., DDI Assessment Cohort(s): Steady-state AUCtau and Cmax of ribociclib with and without co-administration of ARV-471.

Secondary

MeasureTime frame
Phase 1b and Phase 2: AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to ARV-471 in combination with ribociclib. •Laboratory test abnormalities as characterized by type, frequency, intensity (as graded by NCI CTCAE version 5.0), and timing., Fase 1b: Confirmed OR (CR or PR) by investigator assessment. · DoR by investigator assessment. · CBR (confirmed CR or PR at any time, or SD ≥24 weeks) by investigator assessment. · PFS by investigator assessment. Phase 2: DoR by investigator assessment. · CBR (confirmed CR or PR at any time or SD ≥24 weeks) by investigator assessment. · PFS by investigator assessment. · OS., Phase 1b and Phase 2: Plasma concentrations of ARV-471, ARV-473, and ribociclib., Phase 1b: AUCtau and Cmax of ARV-471 with and without co-administration of ribociclib., Phase 2: ctDNA plasma quantitative changes from pre-treatment to evaluate potential predictability of their associations with clinica

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026