Clinical trial · Interventional
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
A Phase 1b Study of ZN-c5 in Combination With Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| ZN-c5 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZN-c5 + abemaciclib combination therapy
- description
- Participants will take abemaciclib (150mg) orally twice a day and ZN-c5 (dose escalation) orally once or twice a day to determine the safety, tolerability, and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D).
- interventionNames
- Drug: ZN-c5
- Drug: Abemaciclib
Primary outcomes (1)
- measure
- Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib
- timeFrame
- Through study completion, anticipated to be 21 months
- description
- Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years of age * Women can be peri- or postmenopausal, as defined by at least one of the following: * Age ≥ 60 years; * Age \< 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females; * Documented bilateral oophorectomy; * Must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication * Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast * Estrogen receptor positive disease * Human Epidermal Growth Factor Receptor 2 negative disease * Measurable disease per Response Evaluation Criteria in Solid Tumors v1.1 Exclusion Criteria: * Prior therapy within the following windows: * Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy \< 14 days; * Any investigational drug therapy \< 28 days or 5 half-lives (whichever is shorter) * Any prior systemic chemotherapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity * Prior treatment with CDK4/6 inhibitors * Unexplained symptomatic endometrial disorders (including, but not limited to, endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
References
Publications (0)
Data not yet available