Clinical trial · Interventional
Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KW-2450 in Combination With Lapatinib and Letrozole in Subjects With Advanced or Metastatic Breast Cancer Whose Tumors Overexpress HER2
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The results of the dose escalation phase did not identify a well-tolerated dose that would permit further study in Phase 2.
Summary
Brief summary (as posted)
This study will determine the highest dose of KW-2450 in combination with lapatinib and letrozole that can be administered safely to subjects with advanced or metastatic breast cancer and to evaluate its effectiveness. This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KW-2450 in combination with lapatinib and letrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escallation
- interventionNames
- Drug: KW-2450 in combination with lapatinib and letrozole
Primary outcomes (1)
- measure
- To establish the safety, tolerability, and recommended Phase 2 dose of KW-2450 administered in combination with lapatinib and letrozole in subjects with previously treated or untreated advanced breast cancer.
- timeFrame
- 30 Days
Secondary outcomes (1)
- measure
- To determine the PK profile of KW-2450, lapatinib, and letrozole when administered together
- timeFrame
- 1 year (or until PD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Histopathologically or cytologically confirmed, advanced or metastatic breast cancer (stage IIIb, IIIc or IV disease) including inflammatory breast cancer or inoperable locally advanced disease. 2. Documented ErbB2 overexpression 3. Estrogen receptor positive (ER+) and/or progesterone positive (PgR+) tumors 4. Measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria 5. A life expectancy of \> 3 months for Phase 1 and \> 6 months for Phase 2 6. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study entry in Phase 1 and ≤ 1 in Phase 2; 7. Normal cardiac ejection fraction 8. Adequate hematologic, hepatic and renal function 9. Post-menopausal female (defined as the absence of a menstrual cycle for at least 12 consecutive months) or male subjects ≥ 18 years of age. 10. Sign an IRB or EC approved informed consent Exclusion Criteria 1. Type 1 diabetes or uncontrolled Type 2 diabetes 2. Subjects showing clinical evidence or with a history of cataract(s), proliferate retinopathy or significant macular edema 3. Subjects with abnormal free T4 values and a history or evidence of thyroid disease 4. Subjects who are unable or unwilling to take metformin 5. Uncontrolled intercurrent illness 6. Known or suspected human immunodeficiency virus (HIV) infection or hepatitis B or C 7. Subjects with inflammatory diseases of the gastrointestinal tract 8. History of other malignancy. Subjects who have been disease free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible; 9. Subjects with extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor 10. A history of prior treatment with other agents specifically targeting IGFRs 11. Subjects who require pharmacological doses of glucocorticoids beyond replacement doses. The use of topical, intra-ocular or inhalation glucocorticoids is permitted
References
Publications (1)
- RESULTDickson MA, P. LoRusso P, E. A. Sausville EA, Rao N, Kobayashi E, Kurman MR, Akinaga S, Schwartz GK. Open-label, sequential, ascending, multi-dose, phase I study of KW-2450 as monotherapy in subjects with previously treated advanced solid tumors. J Clin Oncol 29: 2011 (suppl; abstr 3078)