vepdegestrant
vepdegestrant: developed by 1 company · 18 clinical trials tracked.
vepdegestrant evidence translation
What we can confirm
18 tracked trials
What it means
What to watch
Prepared research question
How could vepdegestrant → ARVN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence5 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| ARVINAS, INC. (ARVN) Locally advanced or metastatic ER+/HER2- breast cancer | Phase 3 |
Clinical Trials (18)showing 10 most recent
A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF VEPDEGESTRANT (PF-07850327) IN ADULT PARTICIPANTS WITH MODERATE AND SEVERE HEPATIC IMPAIRMENT RELATIVE TO HEALTHY PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
Primary endpoint: Maximum observed concentration (Cmax) for vepdegestrant
A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD, SINGLE-DOSE, CROSS-OVER STUDY TO ESTIMATE THE ABSOLUTE BIOAVAILABILITY OF VEPDEGESTRANT (ARV-471, PF-07850327) FOLLOWING ORAL AND INTRAVENOUS DOSING OF THE DRUG TO HEALTHY PARTICIPANTS
Primary endpoint: Dose-normalized (dn) Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Vepdegestrant after oral administration
A PHASE 1, OPEN-LABEL, 2-PERIOD STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF ESOMEPRAZOLE ON THE PHARMACOKINETICS OF SINGLE DOSE VEPDEGESTRANT (ARV-471, PF-07850327) UNDER THE FED CONDITION IN HEALTHY ADULT MALES AND HEALTHY ADULT FEMALES OF NONCHILDBEARING POTENTIAL
Primary endpoint: Maximum observed plasma concentration (Cmax) of vepdegestrant when vepdegestrant is administered alone
AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ER+/HER2- ADVANCED OR METASTATIC BREAST CANCER
Primary endpoint: Phase 1b: Number of Participants With Dose Limiting Toxicities
AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY TO ESTIMATE THE EFFECT OF SINGLE AND MULTIPLE DOSES OF VEPDEGESTRANT (ARV-471, PF-07850327) ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM IN HEALTHY ADULT FEMALES OF NON-CHILDBEARING POTENTIAL.
Primary endpoint: Maximum Observed Plasma Concentration (Cmax) of Midazolam when administered alone
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 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)
Primary endpoint: Phase 1b: Number of Participants With Dose Limiting Toxicities
An Interventional, Phase 1, Open-Label, Fixed Sequence, 2-Period Study to Estimate the Effect of Multiple Doses of Carbamazepine on the Pharmacokinetics of Single Dose Vepdegestrant (ARV-471, PF-07850327) 200 mg Under the Fed Condition in Healthy Adult Males and Females of Nonchildbearing Potential
Primary endpoint: Maximum Observed Plasma Concentration (Cmax) of Vepdegestrant when administered alone
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF VEPDEGESTRANT (ARV-471/PF-07850327) PLUS PALBOCICLIB VERSUS LETROZOLE PLUS PALBOCICLIB FOR THE TREATMENT OF PARTICIPANTS WITH ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE (VERITAC-3)
Primary endpoint: Study Lead-in (SLI): Incidence of Grade 4 neutropenia
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2)
Primary endpoint: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1- All Randomized Participants
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)
Primary endpoint: Phase 1b: Number of Participants With Dose Limiting Toxicities
Frequently asked questions
Who is developing vepdegestrant?
vepdegestrant is being developed by ARVINAS, INC..
How many clinical trials involve vepdegestrant?
BioSniper tracks 18 clinical trials involving vepdegestrant.