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Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

NCT07570966 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2026-05-06

No results posted yet for this study

Summary

Phase I: Characterize safety and tolerability of ERW316 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.

Phase II: Further characterize the safety and tolerability of ERW316 in combination with fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.

Conditions

  • Advanced HR+/HER2- Breast Cancer
  • Advanced CCNE1-amplified Solid Tumors
  • Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

DRUG

ERW316

Oral administration

DRUG

Fulvestrant

Intramuscular injection. Approved medication.

DRUG

Letrozole

Oral administration. Approved medication.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2031-08-01
Completion
2031-08-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570966 on ClinicalTrials.gov