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 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: CERW316A121012025-521913-16
• Study Type: interventional
• Target: 217
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

ERW316; fulvestrant; letrozole; hormone receptor positive; HER-2 negative; Breast cancer; CCNE1 amplification; Prostate cancer

Outcome Measures

Primary Outcomes (4)

• Phase I: Incidence and severity of dose-limiting toxicities (DLTs)

  Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3, unless clearly and inconvertibly assessed as due to disease progression, inter-current illness/injury, concomitant medications, or extraneous causes, that occurs within the first 28 days of treatment in the Phase I part. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.

  28 days

• Phase I and Phase II: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Number of participants with AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.

  Up to approximately 2 years

• Phase I and Phase II: Frequency of dose interruptions, reductions and discontinuations

  Number of participants with dose adjustments (interruptions, reductions, or permanent discontinuation) as a measure of tolerability.

  Up to approximately 2 years

• Phase I and Phase II: Dose intensity

  Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.

  Up to approximately 2 years

Secondary Outcomes (9)

• Phase I and Phase II: Best Overall Response (BOR)

  Up to approximately 2 years

• Phase I and Phase II: Overall Response Rate (ORR)

  Up to approximately 2 years

• Phase I and Phase II: Disease Control Rate (DCR)

  Up to approximately 2 years

• Phase I and Phase II: Clinical Benefit Rate (CBR)

  Up to approximately 2 years

• Phase I and Phase II: Progression Free Survival (PFS)

  Up to approximately 2 years

Study Arms (5)

Phase I: ERW316 single agent (Arm A)

EXPERIMENTAL

ERW316

Drug: ERW316

Phase I: ERW316 in combination with Fulvestrant (Arm B)

EXPERIMENTAL

ERW316 in combination with fulvestrant.

Drug: ERW316; Drug: Fulvestrant

Phase I: ERW316 in combination with letrozole (Arm C)

EXPERIMENTAL

ERW316 in combination with letrozole.

Drug: ERW316; Drug: Letrozole

Phase II, recommended dose (RD)-1: ERW316 in combination with Fulvestrant (Arm D)

EXPERIMENTAL

ERW316 in combination with fulvestrant.

Drug: ERW316; Drug: Fulvestrant

Phase II, RD-2 (optional dose optimization): ERW316 in combination with Fulvestrant (Arm E)

EXPERIMENTAL

ERW316 in combination with fulvestrant.

Drug: ERW316; Drug: Fulvestrant

Interventions

ERW316 DRUG

Oral administration

Phase I: ERW316 in combination with Fulvestrant (Arm B); Phase I: ERW316 in combination with letrozole (Arm C); Phase I: ERW316 single agent (Arm A); Phase II, RD-2 (optional dose optimization): ERW316 in combination with Fulvestrant (Arm E); Phase II, recommended dose (RD)-1: ERW316 in combination with Fulvestrant (Arm D)

Fulvestrant DRUG

Intramuscular injection. Approved medication.

Also known as: Faslodex

Phase I: ERW316 in combination with Fulvestrant (Arm B); Phase II, RD-2 (optional dose optimization): ERW316 in combination with Fulvestrant (Arm E); Phase II, recommended dose (RD)-1: ERW316 in combination with Fulvestrant (Arm D)

Letrozole DRUG

Oral administration. Approved medication.

Also known as: Femara

Phase I: ERW316 in combination with letrozole (Arm C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
• Patients with one of the following histologically or cytologically confirmed advanced cancers:
• Phase I (patients with one of the following cancers, for whom no standard therapy is available or appropriate in the judgment of the investigator):
• HR+/HER2- advanced breast cancer (aBC) with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i and at least one additional line of systemic therapy for metastatic disease.
• Locally advanced or metastatic cancer with CCNE1- amplification. For dose expansion only: no more than 5 prior lines of therapy (ovarian cancer) or 3 prior lines of therapy (gastric or esophageal adenocarcinoma).
• Metastatic castration-resistant prostate adenocarcinoma (mCRPC), with no documented neuroendocrine component, castrate level of testosterone, disease progression on or after at least one line of androgen receptor pathway inhibitor therapy (ARPI) and at least one line of taxane-based chemotherapy, and no more than 3 total prior lines of systemic therapy for metastatic disease.
• Phase II:
• HR+/HER2- aBC with disease progression on or after an endocrine therapy in combination with a CDK4/6 inhibitor for advanced disease, with no more than 2 total lines of endocrine therapy and no prior cytotoxic chemotherapy or antibody-drug conjugate therapy for advanced disease.
• Phase I and Phase II:
• \- Measurable disease as determined by RECIST v1.1, with the following exceptions: aBC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.
• mCRPC only: If no measurable disease is present per PCWG3 modified RECIST, then at least one metastatic lesion must be present on bone scan imaging

You may not qualify if:

• Patients with inadequate bone marrow and/or organ function
• Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.
• Patients with symptomatic visceral disease, including visceral crisis.
• For patients with breast cancer only: Patient is concurrently using hormone replacement therapy.
• Women of childbearing potential (WOCBP) who are unwilling to use highly effective contraception methods
• Pregnant or nursing women

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms

Interventions

Fulvestrant; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): August 1, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share