Clinical trial · Interventional
Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer
A Multicenter, Open-label, Dose Escalation, Phase I Study of LJM716 Administered Intravenously in Combination With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast Cancer or Gastric 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 multicenter, open-label, dose escalation, phase I study to estimate the Maximum Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination with trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2) overexpressing Metastatic Breast Cancer (MBC) or gastric cancer (MGC). The study consists of a dose escalation part and a dose expansion part. LJM716 will be administered intravenously once weekly unless a less frequent dosing regimen such as every 2 weeks or once every 4 weeks is introduced. Patients will continue on their trastuzumab dosing, administered intravenously once weekly at 2mg/kg. During dose escalation, a minimum of 15 patients are anticipated to be treated in successive cohorts. The dose escalation will continue until the MTD/RDE is declared. The RDE dose selected will either be the MTD or a dose below the MTD based on safety and Pharmacokinetic/Pharmacodynamic (PK/PD) considerations. Following the MTD/RDE declaration, approximately 20 MBC and 20 MGC patients will be enrolled in separate arms in the dose expansion part and treated at the MTD/RDE to further assess the safety, tolerability, and anti-tumor activity of the combination.
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 |
|---|---|---|---|
| Advanced HER2-positive Breast Cancer or Gastric Cancer | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LJM716 | Drug | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LJM716 in combination with trastuzumab
- interventionNames
- Drug: LJM716
- Drug: Trastuzumab
Primary outcomes (1)
- measure
- Incidence rate of Dose Limiting Toxicities
- timeFrame
- 4 weeks
- description
- Incidence of dose-limiting toxicities (DLTs)
Secondary outcomes (10)
- measure
- Number of adverse events
- timeFrame
- 4 months
- description
- Safety assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with confirmed HER-2 positive, metastatic or non-operable locally advanced breast or gastric cancer * Metastatic breast cancer patients must have received a minimum of 1 and a maximum of 3 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab, ado-trastuzumab emtansine or lapatinib * Metastatic gastric cancer patients must have received a minimum of 1 and a maximum of 2 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab or ado-trastuzumab emtansine * During the dose expansion part of study, all patients must have at least one measurable lesion as defined by RECIST criteria. * Patients must have at least one prior trastuzumab-containing regimen * Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2 Exclusion Criteria: * Patients with Central Nervous System (CNS) metastasis which are: symptomatic or require treatment for symptom control and/or growing * Prior treatment with any anti-HER3 (Human Epidermal growth factor Receptor 3) treatment * Impaired cardiac function * Prior to the first dose of study treatment, patients who have received systemic antineoplastic therapy or any investigational therapy within 4 weeks or within 5 half- lives of the therapy prior to starting study treatment, whichever is shorter, or for cyclical therapy, within one cycle length (e.g. 6 weeks for nitrosourea, mitomycin-C). * Patients who have a history of primary malignancy other than that being treated in this study, and currently requires active clinical intervention. * Patients who do not have an archival tumor sample (or sections of it) available or readily obtainable. Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available