Clinical trial · Observational
Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer
A Phase II Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Locally Advanced HER2-positive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in completing enrollment within the planned time
Summary
Brief summary (as posted)
This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male with HER2-positive metastatic breast cancer .The subjects will receive 20 mg/kg IV Q2W+ palbociclib 100/125 mg/day orally+/-Fulvestrant 500 mg IM until progressive disease, unacceptable toxicity or death.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KN026 combined with Palbociclib and Fulvestrant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- dose-escalation Phase
- description
- KN026 20 mg/kg + palbociclib125 mg/day+Fulvestrant 500 mg (Patients with HR+/HER2-positive MBC )
- label
- parallel-group expansion Phase
- description
- KN026 20 mg/kg + palbociclib +Fulvestrant 500 mg(Patients with HR+/HER2-positive MBC )
- interventionNames
- Drug: KN026 combined with Palbociclib and Fulvestrant
Primary outcomes (2)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- up to 24 weeks
- description
- The proportion of patients experiencing dose limiting toxicities
- measure
- Objective response rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female subject \>= 18 years; * Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive; * Adequate organ function assessed within 7 days prior to first trial treatment * ECOG score 0 or 1; * Left ventricular ejection fraction (LVEF) ≥ 50% at baseline; * Life expectancy \>3 months Exclusion Criteria: * Untreated active CNS metastasis or leptomeningeal metastasis; * Uncontrolled tumor-related pain; * Has received other anti-tumor treatment or an investigational drug within 28 days or within 5 times of half-life (whichever is shorter, and no less than 2 weeks) prior to the first trial treatment; * Major surgery for any reason within 28 days; * Curative radiation within 3 months of the first dose of trial treatment; * History of uncontrolled intercurrent illness; * Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance
References
Publications (0)
Data not yet available