A Phase 1/2 interventional study of ERW316 and Fulvestrant in Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors and Metastatic Castration-resistant Prostate Cancer (mCRPC), sponsored by Novartis Pharmaceuticals. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Novartis Pharmaceuticals · Phase 1/2, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
Browse Breast Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Phase I (patients with one of the following cancers, for whom no standard therapy is available or appropriate in the judgment of the investigator):
Phase II:
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
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
ERW316
Drug: ERW316
ERW316 in combination with fulvestrant.
Drug: ERW316 · Drug: Fulvestrant
ERW316 in combination with letrozole.
Drug: ERW316 · Drug: Letrozole
ERW316 in combination with fulvestrant.
Drug: ERW316 · Drug: Fulvestrant
ERW316 in combination with fulvestrant.
Drug: ERW316 · Drug: Fulvestrant
Oral administration
Intramuscular injection. Approved medication.
Also known as: Faslodex
Oral administration. Approved medication.
Also known as: Femara
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 2 years
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).
Time frame: Up to approximately 2 years
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).
Time frame: Up to approximately 2 years
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).
Time frame: Up to approximately 2 years
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).
Time frame: Up to approximately 2 years
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).
Time frame: Up to approximately 2 years
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).
Time frame: Up to approximately 2 years
Phase I and Phase II: Area under the plasma concentration-time curve (AUC) of ERW316
Pharmacokinetic (PK) parameters based on plasma concentrations of ERW316.
Time frame: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 22. 1 cycle = 28 days
Phase I and Phase II: Maximum plasma concentration (Cmax) of ERW316
PK parameters based on plasma concentrations of ERW316.
Time frame: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 22. 1 cycle = 28 days
Phase I and Phase II: Time to reach maximum plasma concentration (Tmax) of ERW316
PK parameters based on plasma concentrations of ERW316.
Time frame: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 22. 1 cycle = 28 days
No study locations are listed for this record.
Plan to share: 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/.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals