Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LJM716 · 3 trials · 6 indications
The open-label dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or Recommended Phase II Dose (s) guided by the safety (incidence of dose limiting toxicities), efficacy, pharmacokinetics and pharmacodynamics data.
Progression-free survival is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate assessment.
Incidence of dose-limiting toxicities (DLTs)
| Arm | Type | Description |
|---|---|---|
| LJM716-BYL719 arm | EXPERIMENTAL | approximately 42 previously treated esophageal squamous cell carcinoma (ESCC) patients will be enrolled to the LJM716-BYL719 combination arm to evaluate the anti-tumor activity and further assess the safety, tolerability and anti-tumor activity of the combination versus current therapies (physician's choice of paclitaxel, docetaxel or irinotecan). |
| Paclitaxel, Docetaxel or Irinotecan arm | ACTIVE_COMPARATOR | approximately 42 previously treated esophageal squamous cell carcinoma (ESCC) patients will be enrolled to the Paclitaxel, Docetaxel or Irinotecan arm (physician's choice arm) to evaluate the anti-tumor activity and further assess the safety, tolerability and anti-tumor activity of the LJM716-BYL719 combination versus current therapies (physician's choice of paclitaxel, docetaxel or irinotecan). |
| LJM716 in combination with trastuzumab | EXPERIMENTAL | - |
| Dose escalation and dose expansion | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| LJM716 | DRUG | LJM716 (10-40 mg/kg) will be given as a once weekly infusion beginning on cycle 1 day 1. The doses of LJM716 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established. |
| BYL719 | DRUG | BYL719 (200-400 mg) will be administered orally on a once daily schedule starting cycle 1 day 1. The doses of BYL719 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established. |
| Paclitaxel | DRUG | In the Phase II portion of the study Paclitaxel is one of the 3 physician's choice drug which allows single-agent paclitaxel to be used per manufacturer's label. |
| Docetaxel | DRUG | In the Phase II portion of the study Docetaxel is one of the 3 physician's choice drug which allows single-agent docetaxel to be used per manufacturer's label. |
| Irinotecan | DRUG | In the Phase II portion of the study Irinotecan is one of the 3 physician's choice drug which allows single-agent irinotecan to be used per manufacturer's label |
| Trastuzumab | DRUG | Trastuzumab |
Inclusion Criteria: * Histologically confirmed esophageal squamous cell carcinoma (ESCC) * No more than one prior chemotherapy regimen for recurrent or metastatic ESCC (for Phase II only). * Progression during or after platinum-based therapy for recurrent or metastatic ESCC, or recurrence within 6 ...
LJM716 is an investigational oncology drug studied in adults with advanced HER2-positive breast cancer or gastric cancer, esophageal squamous cell carcinoma, and squamous cell carcinoma of the head and neck. It has been tested in patients whose tumors express these features, including previously treated esophageal squamous cell carcinoma, and remains in clinical development.
LJM716 is developed by Novartis AG, which trades under the ticker NVS. The company sponsored the Phase 1 clinical program evaluating the drug in advanced solid tumors, including HER2-positive breast and gastric cancer, esophageal squamous cell carcinoma, and squamous cell carcinoma of the head and neck.
LJM716 is in Phase 1 clinical development. It is an investigational agent and has not been approved for any indication. All three of its recorded Phase 1 trials are listed as completed, and no trials are currently active.
LJM716 has been evaluated in three completed Phase 1 trials. NCT01602406 tested LJM716 combined with trastuzumab in HER2 overexpressing metastatic breast or gastric cancer with 64 patients. NCT01598077 studied LJM716 in head and neck squamous cell carcinoma or HER2-positive breast or gastric cancer with 54 patients. NCT01822613 combined LJM716 with BYL719 in previously treated esophageal squamous cell carcinoma with 48 patients.
LJM716 is a small molecule developed as an oncology agent, and the trials paired it with trastuzumab in HER2 overexpressing disease and with BYL719 in esophageal squamous cell carcinoma. These combinations were studied in biomarker-selected patient populations across Phase 1 testing.
The LJM716 Phase 1 program enrolled patients across three completed studies. NCT01602406 enrolled 64 patients, NCT01598077 enrolled 54 patients, and NCT01822613 enrolled 48 patients. All trials were uncontrolled, non-randomized, and open label, and they enrolled adults aged 18 years and older.