Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC

Phase 1 & 2

Waitlist Available

Research Sponsored by Nuvation Bio Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks through study treatment, an average of 6 months

Awards & highlights

No Placebo-Only Group

Summary

NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy. The study population is comprised of adults with HR+HER2- aBC. Patients will self-administer NUV-422 orally in 28-day cycles and receive 500 mg fulvestrant intramuscularly (IM) on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks through study treatment, an average of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks through study treatment, an average of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks through study treatment, an average of 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fulvestrant

Phase 2 Dose Expansion: Objective Response Rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 2 fulvestrant monotherapyExperimental Treatment1 Intervention

500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter.

Group II: Phase 2 NUV-422 monotherapyExperimental Treatment1 Intervention

NUV-422 will be administered orally at the RP2cD.

Group III: Phase 2 NUV-422 + fulvestrantExperimental Treatment2 Interventions

NUV-422 will be administered orally at the RP2cD in combination with fulvestrant. 500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter.

Group IV: Phase 1b Dose EscalationExperimental Treatment2 Interventions

NUV-422 will be administered orally at escalating dose levels in combination with fulvestrant until the recommended Phase 2 combination dose (RP2cD) is determined. 500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~4030

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