New cancer drug trial pulled before it even started
NCT ID NCT07570966
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This was a planned early-stage trial to test a new oral drug called ERW316, alone or with hormone therapies, in people with advanced breast cancer or other solid tumors. The study aimed to find a safe dose and check for side effects. However, the trial was withdrawn before any participants were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ERW316 (oral drug)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced breast cancer and other solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This trial was withdrawn before enrolling any participants, so no data is available. It is very early-stage research, and the drug may not prove safe or effective in humans.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Aug 2031
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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