Clinical trial · Interventional
A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer
A Phase 1b Study of Poziotinib in Combination With T-DM1 in Women With Advanced or Metastatic 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): Dose limiting toxicity
Summary
Brief summary (as posted)
This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing of T-DM1 (3.6 mg/kg IV on Day 1 of each 21-day cycle) in women with advanced or metastatic HER2+ breast cancer. The poziotinib dose identified in Part 1 of the study will be used in combination with standard dose of T-DM1 in Part 2 of the study to confirm the poziotinib dose and evaluate the preliminary efficacy of the combination therapy.
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 |
|---|---|---|---|
| Poziotinib | Drug | Poziotinib | ALIAS |
| T-DM1 | Drug | Trastuzumab Emtansine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Poziotinib
- description
- * Part 1: Dose Finding The MTD/MAD of poziotinib in combination with the standard dose of T-DM1 will be determined by using a "3+3" design. At least 3 patients may be enrolled in each cohort before a decision is made to proceed to the next cohort. * Part 2: MTD/MAD Expansion An additional 10 patients will be treated at the dose identified during Part 1 to further evaluate the combination at the MTD or the MAD.
- interventionNames
- Drug: Poziotinib
- Drug: T-DM1
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 3 Years
- description
- Evaluate the Objective Response Rate (ORR) in patients treated with daily poziotinib in combination with T-DM1 (every 3 weeks) in women with advanced or metastatic HER2 positive breast cancer.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must be female, at least 18 years of age, but not older than 90 years, with advanced or metastatic HER2+ breast cancer and a life expectancy of more than 6 months * Patient must have confirmed HER2 overexpression or gene-amplified tumor via immunohistochemistry \[IHC\] with IHC 3+ or IHC 2+ with confirmatory fluorescence in situ hybridization \[FISH\]+ or \[ISH\]+ * Patients must have had at least 1 line of anti-HER2 directed therapy either in the metastatic or early-stage disease setting * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: * Patient has had previous treatment with poziotinib. * Patient has received anticancer chemotherapy, TKIs, biologics, immunotherapy, radiotherapy, or investigational treatment within 15 days. (There is no washout for hormonal therapy for breast cancer). * Patient has a life expectancy less than 3 years due to other malignancies. * Patient is pregnant or breast-feeding.
References
Publications (0)
Data not yet available