Clinical trial · Interventional
A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors
NCT01911936CI-TRIAL-00048893completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 evaluate safety and tolerability to estimate the MTDand/or recommended dose.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LM716 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LJM716
- interventionNames
- Drug: LM716
Primary outcomes (1)
- measure
- Incidence of dose-limiting toxicities (DLTs) in the dose escalation part
- timeFrame
- First cycle (28 days)
Secondary outcomes (4)
- measure
- Frequency and severity of adverse events, number of and reasons for
- timeFrame
- from informed consent till 30 days after end of treatment
- measure
- LJM716 serum concentration-time- profile and estimated PK
- timeFrame
- up to 10 cycle (1 cycle = 28 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with the following indications: i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists: * For breast cancer: documented 3+ by immunohistochemistry, or amplification by in situ hybridization * For gastric cancer (including GE junction tumors): documented 3+ by immunohistochemistry, or 2+ by immunohistochemistry and amplification by in situ hybridization OR, ii) (Dose escalation part only): Recurrent or metastatic SCCHN regardless of HER2 status for which no effective treatment option exists OR, iii) Recurrent or metastatic ESCC regardless of HER2 status for which no effective treatment option exists 2. ECOG Performance Status of 0-2 3. Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable. 4. Willingness and ability to comply with all study procedures 5. Written informed consent obtained prior to any screening procedures 6. During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria
References
Publications (1)
- DERIVEDTakahashi S, Kobayashi T, Tomomatsu J, Ito Y, Oda H, Kajitani T, Kakizume T, Tajima T, Takeuchi H, Maacke H, Esaki T. LJM716 in Japanese patients with head and neck squamous cell carcinoma or HER2-overexpressing breast or gastric cancer. Cancer Chemother Pharmacol. 2017 Jan;79(1):131-138. doi: 10.1007/s00280-016-3214-4. Epub 2016 Dec 9. PMID 27942917