Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
← catalyst calendarSponsored by Nuvation Bio Inc. (industry) · NUVB — their whole pipeline →.
Phase
Phase 1/2
Status
Withdrawn
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
0actual
Sites
5
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Sponsor decision
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Sep 2022 | estimated | When the study began enrolling |
| Primary completion | Jun 2025 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2022-01-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2023-07-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Breast Cancer
- Metastatic Breast Cancer
- Breast Cancer
- Breast Carcinoma
- Cancer of the Breast
- Cancer of Breast
- Malignant Tumor of Breast
- Breast Tumor
Interventions
- Drug: NUV-422
- Drug: Fulvestrant — also filed as Faslodex
Primary outcomes
what the primary-completion date above is the date OFPhase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with fulvestrant to determine the recommended Phase 2 combination dose (RP2cD)
measured During the DLT period (28 days)
Phase 2 Dose Expansion: Objective Response Rate (ORR)
measured Every 8 weeks through study treatment, an average of 6 months
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