Phase 2 Breast Cancer Trial, Not Yet Recruiting NCT06757335 Sponsor: Hinova Pharmaceuticals Inc. Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Not Yet Recruiting

NCT06757335
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • Women between 18 and 75 years old at the time of signing the consent form.
  • People with breast cancer that has spread, come back, or cannot be removed by surgery, where the cancer is confirmed by tissue testing to be ER-positive and HER2-negative.
  • People who have previously received at least one hormone-based treatment (lasting 6 months or more) and no more than two rounds of chemotherapy for the advanced or returned stage of their disease (the chemotherapy limit applies to the dose-finding stage of the trial only); or, in the third stage of the trial, people who have not yet received treatment for advanced disease but whose cancer may be suitable for a CDK4/6 inhibitor type of therapy (confirm with trial site).
  • People whose cancer has been confirmed by imaging scans to have grown or spread either during or after the last cancer treatment they received before joining the trial.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People with a known or suspected allergy to any ingredient in HP568, or to any ingredient in palbociclib (the palbociclib allergy criterion applies to the third stage of the trial only).
  • People who received the drug fulvestrant within 42 days before the first dose, or who received other hormone therapies such as tamoxifen, toremifene, letrozole, anastrozole, or exemestane within 14 days before the first dose.
  • People who have previously received other drugs of a similar type to HP568, such as ARV-471 (confirm with trial site for full list).
  • People who received nitrosourea or mitomycin chemotherapy drugs within 6 weeks before the first dose, or who received any other anti-cancer treatment — including immunotherapy, chemotherapy, radiation, or targeted therapy — within 28 days before the first dose (or within 5 half-lives of that treatment, whichever is shorter).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026

Contact this trial

Phone: +86-28-85058465

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Hinova Pharmaceuticals Inc.
Registry
ClinicalTrials.gov
Start date
7 January 2025
Est. completion
31 January 2026

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Primary endpoints

Stage I: the incidence of TEAE of HP568; Stage I: Incidence of dose limiting toxicity DLT, maximum tolerated dose MTD (if possible).; Stage III: Evaluate safety during the dose escalation phase of combination therapy; Stage III: Evaluate tolerance during the dose escalation phase of combination therapy; Stage III: Evaluate the 24 week clinical benefit rate (CBR) during the dose escalation phase of combination therapy; Stage II: 24 week clinical benefit rate (CBR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov