Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DJI136 · 1 trial · 1 indication
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first 28 days after DJI136 infusion and meets the criteria defined in the protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST v1.1 is defined as the proportion of patients with a confirmed best overall response of Complete response (CR) or Partial response (PR).
| Arm | Type | Description |
|---|---|---|
| Phase I | EXPERIMENTAL | Dose escalation with DJI136 |
| Phase II | EXPERIMENTAL | Treatment at the recommended dose(s) of DJI136 as identified in Phase I. |
| Name | Type | Description |
|---|---|---|
| DJI136 | DRUG | DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion. |
Inclusion Criteria: * Phase I: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (that included a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor) according to the local SOC (2L+), unless the patient was ineligible to receive such therap...
DJI136 is an investigational small molecule being developed for the treatment of Extensive-stage Small Cell Lung Cancer (ES-SCLC). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in a clinical trial to evaluate its safety and efficacy in patients with this condition.
DJI136 is a DLL3-targeted therapy, as indicated by its clinical trial title. It is designed to target DLL3, a protein that is often expressed in small cell lung cancer cells. By targeting DLL3, DJI136 aims to interfere with the cancer cells that express this protein, potentially offering a treatment option for patients with Extensive-stage Small Cell Lung Cancer.
DJI136 is being developed by Novartis AG, a global healthcare company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of DJI136 in patients with Extensive-stage Small Cell Lung Cancer.
DJI136 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval for commercial use. The Phase 1 trial is actively recruiting participants to study the drug's safety, tolerability, and preliminary efficacy in patients with Extensive-stage Small Cell Lung Cancer.
DJI136 is being studied in a Phase 1 clinical trial with the identifier NCT07564401. This trial is titled 'A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy' and is currently recruiting participants. The study is enrolling approximately 80 patients with Extensive-stage Small Cell Lung Cancer and is being conducted in the United States and Singapore.
DJI136 is described as a DLL3-targeted CAR-T therapy in its clinical trial title. However, it is also classified as a small molecule in the drug profile. This suggests that DJI136 may be a small molecule that targets DLL3, potentially mimicking or enhancing CAR-T mechanisms, though the exact nature of the therapy is not fully detailed in the available information.