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Advanced HR+/HER2- Breast CancerPhase 1/2NCT07570966

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

A Phase 1/2 study testing ERW316, Fulvestrant and Letrozole in people with Advanced HR+/HER2- Breast Cancer and Advanced CCNE1-amplified Solid Tumors, run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ERW316, Fulvestrant and Letrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Jun 2026to 1 Aug 2031
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 12Show fewer
  • 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

Who cannot join

  • 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
  • Other protocol-defined inclusion/exclusion criteria may apply.

About this study

Official title: An Open-label, Multi-center, Phase I/II 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

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.

Read the detailed description

This is a first-in-human, open-label, Phase I/II, multi-center study consisting of an ERW316 single agent arm in patients with advanced HR+/HER2- breast cancer, other advanced solid tumors harboring CCNE1 amplification, and metastatic castration-resistant prostate cancer, and a combination treatment arm of ERW316 with fulvestrant or letrozole in patients with advanced HR+/HER2- breast cancer. Single agent escalation may be followed by an expansion part stratified by disease indication. The escalation of the fulvestrant combination arm may continue into a randomized, open-label, Phase II with optional dose optimization in advanced HR+/HER2- breast cancer patients.

Being tested
ERW316, Fulvestrant, Letrozole
Keywords
ERW316, fulvestrant, letrozole, hormone receptor positive, HER-2 negative, Breast cancer, CCNE1 amplification, Prostate cancer
Medical subject headings
Breast Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERW316Drug

    Oral administration

  • FulvestrantDrug

    Also called Faslodex

    Intramuscular injection. Approved medication.

  • LetrozoleDrug

    Also called Femara

    Oral administration. Approved medication.

Study groups in NCT07570966
Study groupRoleWhat they receive
Phase I: ERW316 single agent (Arm A)ExperimentalERW316
Receives: Drug: ERW316
Phase I: ERW316 in combination with Fulvestrant (Arm B)ExperimentalERW316 in combination with fulvestrant.
Receives: Drug: ERW316; Drug: Fulvestrant
Phase I: ERW316 in combination with letrozole (Arm C)ExperimentalERW316 in combination with letrozole.
Receives: Drug: ERW316; Drug: Letrozole
Phase II, recommended dose (RD)-1: ERW316 in combination with Fulvestrant (Arm D)ExperimentalERW316 in combination with fulvestrant.
Receives: Drug: ERW316; Drug: Fulvestrant
Phase II, RD-2 (optional dose optimization): ERW316 in combination with Fulvestrant (Arm E)ExperimentalERW316 in combination with fulvestrant.
Receives: Drug: ERW316; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 28 days

  2. 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.

    Measured: Up to approximately 2 years

  3. 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.

    Measured: Up to approximately 2 years

  4. Phase I and Phase II: Dose intensity

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

    Measured: Up to approximately 2 years

Secondary outcomes (9)

  1. Phase I and Phase II: Best Overall Response (BOR)

    BOR per RECIST v1.1 is defined as the best overall confirmed response recorded from the start of the treatment until progressive disease (PD), death, start of new therapy, withdrawal of consent or end of study, whatever comes first.

    Efficacy will be based on the investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or Prostate Cancer Working Group 3 (PCWG3) criteria including PCWG3-modified RECIST v1.1 (only for patients with prostate cancer).

    Measured: Up to approximately 2 years

  2. Phase I and Phase II: Overall Response Rate (ORR)

    ORR per RECIST v1.1 is defined as the proportion of patients with a BOR of Complete response (CR) or Partial response (PR).

    Efficacy will be based on the investigator assessment per RECIST v1.1, or PCWG3 criteria including PCWG3-modified RECIST v1.1 (only for patients with prostate cancer).

    Measured: Up to approximately 2 years

  3. Phase I and Phase II: Disease Control Rate (DCR)

    DCR per RECIST v1.1 is defined as the proportion of patients with a BOR of CR, PR, or Stable disease (SD).

    Efficacy will be based on the investigator assessment per RECIST v1.1, or PCWG3 criteria including PCWG3-modified RECIST v1.1 (only for patients with prostate cancer).

    Measured: Up to approximately 2 years

  4. Phase I and Phase II: Clinical Benefit Rate (CBR)

    CBR per RECIST v1.1 is defined as the proportion of patients with a BOR of CR, PR, or an overall lesion response of SD or Non-CR/Non-PD which lasts for at least 24 weeks.

    Efficacy will be based on the investigator assessment per RECIST v1.1, or PCWG3 criteria including PCWG3-modified RECIST v1.1 (only for patients with prostate cancer).

    Measured: Up to approximately 2 years

  5. Phase I and Phase II: Progression Free Survival (PFS)

    PFS per RECIST 1.1 is defined as the time from the date of start of study treatment (Phase I) or the date of randomization (Phase II) to the date of the first documented progression or death due to any cause.

    Efficacy will be based on the investigator assessment per RECIST v1.1, or PCWG3 criteria including PCWG3-modified RECIST v1.1 (only for patients with prostate cancer).

    Measured: Up to approximately 2 years

  6. Phase II: Duration of Response (DOR)

    DOR per RECIST v1.1 is the time between the first documented response (CR or PR) and the date of progression by local review as applicable or death due to any cause.

    Efficacy will be based on the investigator assessment per RECIST v1.1, or PCWG3 criteria including PCWG3-modified RECIST v1.1 (only for patients with prostate cancer).

    Measured: Up to approximately 2 years

  7. Phase I and Phase II: Area under the plasma concentration-time curve (AUC) of ERW316

    Pharmacokinetic (PK) parameters based on plasma concentrations of ERW316.

    Measured: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 22. 1 cycle = 28 days

  8. Phase I and Phase II: Maximum plasma concentration (Cmax) of ERW316

    PK parameters based on plasma concentrations of ERW316.

    Measured: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 22. 1 cycle = 28 days

  9. Phase I and Phase II: Time to reach maximum plasma concentration (Tmax) of ERW316

    PK parameters based on plasma concentrations of ERW316.

    Measured: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 22. 1 cycle = 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start30 Jun 2026 (estimated)
  3. Primary completion1 Aug 2031 (estimated)
  4. Study completion1 Aug 2031 (estimated)

Why it stopped: Business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07570966
Sponsor's protocol ID
CERW316A12101
Other IDs
2025-521913-16, 2025
Status last verified
Jun 2026
First submitted
30 Apr 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ERW316, Fulvestrant and Letrozole in people with Advanced HR+/HER2- Breast Cancer and Advanced CCNE1-amplified Solid Tumors, run by Novartis Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Incidence and severity of dose-limiting toxicities (DLTs) (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07570966.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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