Clinical trial · Interventional
A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015)
A Phase I Investigation of the Combination of MK-2206, Trastuzumab and Lapatinib in HER2+ Solid Tumors
- 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 study will assess the safety, tolerability, and the maximum tolerated dose (MTD) of MK-2206 in combination with both trastuzumab and trastuzumab/lapatinib in participants with human epidermal growth factor receptor 2 positive (HER2+) breast cancer and other solid tumors. The primary hypothesis of this study is that the combination of oral MK-2206 with trastuzumab or with trastuzumab/lapatinib will be well tolerated in participants with advanced HER2+ solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lapatinib | Drug | Lapatinib | ALIAS |
| MK-2206 | Drug | Akt Inhibitor MK2206 | ALIAS |
| Trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Pt. 1: MK-2206 45mg, QOD + Trastuzumab
- description
- Participants in Part 1 (Pt. 1) receive MK-2206 45 mg every other day (QOD), taken orally. In combination with MK-2206, trastuzumab is administered by intravenous (IV) infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg every 3 weeks (q3wk).
- interventionNames
- Drug: MK-2206
- Biological: Trastuzumab
- type
- EXPERIMENTAL
- label
- Pt. 1: MK-2206 60mg, QOD + Trastuzumab
- description
- Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
- interventionNames
- Drug: MK-2206
- Biological: Trastuzumab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a histologically or cytologically-confirmed locally advanced or metastatic HER2+ solid tumor. * Have performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Have adequate organ function. * Female participants have a negative pregnancy test 72 hours prior to receiving the first dose of study medication. * Have completed any major surgery for a minimum of 28 days prior to enrollment in this study. * Able to swallow tablets and has no surgical or anatomical condition that will preclude the patient from swallowing or absorbing oral medications on an ongoing basis. Exclusion Criteria: * Had chemotherapy, radiotherapy or biological therapy within 4 weeks of screening. Participants receiving trastuzumab and/or lapatinib prior to screening must be off both medications for 1 week prior to first dose of MK-2206 if trastuzumab had been administered at 2 mg/kg weekly and 3 weeks if trastuzumab had been administered at 6 mg/kg weekly. * Currently participating or has participated in a study with an investigational compound or device within 30 days, or 5x half-life from prior agents, whichever is longer, of Day 1 of this study * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has a primary CNS tumor. * Has known hypersensitivity to the components of study drugs or its analogs. * Has a history or evidence of heart disease. * Has uncontrolled hypertension or diabetes. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding or is expecting to conceive or father children during the study. * Is HIV positive. * Has symptomatic ascites or pleural effusion. * Is receiving treatment with oral corticosteroids for reason other than CNS metastasis.
References
Publications (1)
- RESULTHudis C, Swanton C, Janjigian YY, Lee R, Sutherland S, Lehman R, Chandarlapaty S, Hamilton N, Gajria D, Knowles J, Shah J, Shannon K, Tetteh E, Sullivan DM, Moreno C, Yan L, Han HS. A phase 1 study evaluating the combination of an allosteric AKT inhibitor (MK-2206) and trastuzumab in patients with HER2-positive solid tumors. Breast Cancer Res. 2013 Nov 19;15(6):R110. doi: 10.1186/bcr3577. PMID 24252402