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A Phase I/II Trial to Evaluate Oral HP568 Tablets in Patients with ER+/HER2 Advanced Breast Cancer

NCT06757335 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-01-03

No results posted yet for this study

Summary

This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and preliminary efficacy of HP568 alone and in combination with palbociclib in patients with ER+/HER2- locally advanced or metastatic breast cancer.

Conditions

Interventions

DRUG

HP568

In the I/II stage: HP568 administered QD or BID for 28 day cycles.

DRUG

HP568 in combination with palbociclib

In the III stage: Daily oral dosages of HP568 for 28 days in combination with palbociclib for 21 days.

Sponsors & Collaborators

  • Hinova Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-07
Primary Completion
2026-01-31
Completion
2026-11-27
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06757335 on ClinicalTrials.gov