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 developed by Novartis AG for extensive-stage small cell lung cancer (ES-SCLC). It is in Phase 1 clinical development and has not been approved by the FDA. One trial is currently recruiting, with a planned enrollment of 80 participants.
DJI136 is being studied for the treatment of extensive-stage small cell lung cancer (ES-SCLC), an advanced form of lung cancer. It is an investigational therapy in Phase 1 testing and is not approved for any indication. The ongoing trial enrolls adults 18 years and older.
DJI136 is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the Phase 1 study evaluating the drug in extensive-stage small cell lung cancer. No partnership or licensing details for DJI136 have been disclosed.
DJI136 is in Phase 1 clinical development. It is investigational and has not received FDA approval. The single registered trial is a controlled Phase 1 study that is currently recruiting participants with extensive-stage small cell lung cancer across sites in the United States, Australia, Singapore, and South Korea.
DJI136 is being evaluated in one clinical trial, NCT07564401, titled "A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy." The Phase 1 study is recruiting 80 participants with extensive-stage small cell lung cancer in the United States, Australia, Singapore, and South Korea. It is controlled but not randomized or double-blind.