Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZL-1310 · 5 trials · 8 indications
Progression-free survival (PFS) is defined as the time from first investigational medicinal product (IMP) administration until the earliest date of disease progression according to Response Evaluation Criteria In Solid Tumours (RECIST 1.1) based on investigator assessments or death from any cause, whichever occurs first.
Number of subjects with treatment-emergent adverse events (TEAEs)
Number of subjects with serious adverse events (SAEs)
Confirmed objective response rate (ORR) determined by blinded independent central review (BICR) in Phase 2
Number of subjects with Dose Limiting Toxicities (DLTs)
Number of subjects with treatment-emergent adverse events (TEAEs)
Number of subjects with serious adverse events
Number of subjects with treatment emergent adverse events leading to dose modifications and/or study treatment discontinuation
Number of subjects with serious adverse events
antitumor activity per RECIST v1.1 by investigator's assessment
objective response rate per RECIST v1.1
disease control rate per RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| ZL-1310 in Combination with Checkpoint Inhibitor | EXPERIMENTAL | - |
| Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor | ACTIVE_COMPARATOR | - |
| Arm 1 | EXPERIMENTAL | ZL-1310 as a single agent |
| Arm 2 | ACTIVE_COMPARATOR | Investigator's Choice of Therapy |
| Part 1: obrixtamig + ZL-1310 (dosing regimen 1) | EXPERIMENTAL | - |
| Part 1: obrixtamig + ZL-1310 (dosing regimen 2) | EXPERIMENTAL | - |
| Part 2: obrixtamig + ZL-1310 + atezolizumab | EXPERIMENTAL | - |
| Single Arm | EXPERIMENTAL | ZL-1310 as a single agent |
| Dose Escalation: Part 1A | EXPERIMENTAL | ZL-1310 as a single-agent |
| Dose Expansion: Part 1B | EXPERIMENTAL | ZL-1310 in combination with Atezolizumab |
| Dose Escalation: Part 1C | EXPERIMENTAL | ZL-1310 in combination with Atezolizumab and Carboplatin as induction and followed by ZL-1310 and Atezolizumab as maintenance |
| Dose Expansion: Arm 1 (Part 2) | EXPERIMENTAL | Dose level 1 of ZL-1310 established from single-agent dose-escalation |
| Dose Expansion: Arm 2 (Part 2) | EXPERIMENTAL | Dose level 2 of ZL-1310 established from single-agent dose escalation |
| Dose Extension: Arm 1 (Part 2) | EXPERIMENTAL | ZL-1310 as a single agent |
| Doublet Dose Optimization: Arm 1 (Part 3A) | EXPERIMENTAL | Dose level 1 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab |
| Doublet Dose Optimization: Arm 2 (Part 3A) | EXPERIMENTAL | Dose level 2 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab |
| Triplet Dose Optimization: Arm 1 (Part 4A) | EXPERIMENTAL | Dose level 1 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab + Carboplatin induction followed by ZL-1310 + Atezolizumab as maintenance |
| Triplet Dose Optimization: Arm 2 (Part 4A) | EXPERIMENTAL | Dose level 2 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab + Carboplatin induction followed by ZL-1310 + atezolizumab as induction |
| Dose Extension: Part 2-1 | EXPERIMENTAL | single-agent dose extension for Post-anti-DLL3 |
| Doublet Dose Extension: Part 3B | EXPERIMENTAL | Doublet dose extension for 1L maintenance only OR 1L induction + maintenance; to be initiated at the discretion of the sponsor based on the available emerging data. |
| Triplet Dose Extension: Part 4B | EXPERIMENTAL | Triplet dose extension for 1L induction + maintenance; to be initiated at the discretion of the sponsor based on the available emerging data. |
| Name | Type | Description |
|---|---|---|
| ZL-1310 in combination with Atezolizumab or Durvalumab | COMBINATION_PRODUCT | ZL-1310 ADC in combination with checkpoint inhibitor |
| Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin | COMBINATION_PRODUCT | Platinum-based chemotherapy in combination with a checkpoint inhibitor |
| Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance | COMBINATION_PRODUCT | Standard of Care Platinum-based chemotherapy in combination |
| ZL-1310 | DRUG | ZL-1310 as a single-agent |
| Investigator's Choice of Therapy | DRUG | Topotecan or Amrubicin |
| Obrixtamig | DRUG | Obrixtamig |
| Atezolizumab | DRUG | Atezolizumab |
| Carboplatin | DRUG | Drug Carboplatin |
Inclusion Criteria: * Histologically or cytologically confirmed ES-SCLC * No prior systemic therapy has been received * Medically eligible to receive standard platinum-based chemotherapy with atezolizumab or durvalumab as first-line therapy * Eastern Cooperative Oncology Group performance status of...
ZL-1310 is an investigational small molecule developed by Zai Lab Limited for the treatment of small cell lung cancer and other solid tumors. It is being studied both as a single agent and in combination with checkpoint inhibitors in extensive-stage and relapsed small cell lung cancer.
ZL-1310 is being developed for extensive-stage small cell lung cancer, relapsed small cell lung cancer, and selected solid tumors. It is also being studied in combination with checkpoint inhibitors such as atezolizumab or durvalumab as first-line therapy for extensive-stage small cell lung cancer.
ZL-1310 targets DLL3, a protein expressed on the surface of small cell lung cancer cells and other neuroendocrine tumors. By binding DLL3, the drug is designed to act on tumor cells that carry this target, which is a defining feature of small cell lung cancer biology.
ZL-1310 is developed by Zai Lab Limited, a biopharmaceutical company traded on the Nasdaq under the ticker ZLAB. Zai Lab is running the clinical development program for ZL-1310 across small cell lung cancer and other solid tumor indications.
ZL-1310 is in Phase 3 clinical development. Two Phase 3 trials are planned or underway: one evaluating ZL-1310 in combination with a checkpoint inhibitor as first-line therapy for extensive-stage small cell lung cancer, and one comparing ZL-1310 with investigator's choice of therapy in relapsed small cell lung cancer.
ZL-1310 is being studied in several trials, including NCT07218146 (DLLEVATE), a recruiting Phase 3 study in relapsed small cell lung cancer, and NCT07796100, a Phase 3 study in extensive-stage small cell lung cancer. Earlier-stage studies include NCT06885281 in solid tumors and NCT07707895 in combination with obrixtamig.