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 drug being studied for the treatment of HER2-positive breast cancer, HER2-positive gastric cancer, squamous cell carcinoma of the head and neck, and esophageal squamous cell carcinoma. It is being developed by Novartis AG and is currently in Phase 1 clinical development.
LJM716 is a small molecule being developed by Novartis AG for the treatment of HER2-positive cancers. It is being studied in combination with other therapies for the treatment of HER2-positive breast cancer and gastric cancer, as well as squamous cell carcinoma of the head and neck and esophageal squamous cell carcinoma.
LJM716 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is conducting clinical trials to evaluate the safety and efficacy of LJM716 in patients with HER2-positive breast cancer, HER2-positive gastric cancer, squamous cell carcinoma of the head and neck, and esophageal squamous cell carcinoma.
LJM716 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy in patients with HER2-positive breast cancer, HER2-positive gastric cancer, squamous cell carcinoma of the head and neck, and esophageal squamous cell carcinoma.
LJM716 has been studied in several Phase 1 clinical trials, including NCT01598077, NCT01602406, and NCT01822613. These trials evaluated LJM716 alone or in combination with other therapies in patients with HER2-positive breast cancer, HER2-positive gastric cancer, squamous cell carcinoma of the head and neck, and esophageal squamous cell carcinoma.
No, LJM716 is not the same as BYL719. LJM716 is being studied in combination with BYL719 in a clinical trial for the treatment of esophageal squamous cell carcinoma. LJM716 is a separate investigational drug developed by Novartis AG.