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 antibody-drug conjugate developed by Zai Lab Limited for oncology. It is being studied in small cell lung cancer, including extensive-stage and relapsed disease, and in other solid tumors. ZL-1310 has received Orphan Drug and Fast Track designations from the FDA and is in Phase 3 development.
ZL-1310 targets DLL3, a protein target, and is built as an antibody-drug conjugate. By binding DLL3, the conjugate directs its payload toward DLL3-expressing tumor cells. DLL3 is the molecular target named for this asset, and the program is being studied in small cell lung cancer and other solid tumors.
ZL-1310 is being developed for small cell lung cancer, including extensive-stage SCLC as first-line therapy and relapsed SCLC, as well as other solid tumors and neuroendocrine cancers. It is investigational and has not been established as a treatment outside clinical trials. Phase 3 studies are under way in extensive-stage and relapsed SCLC.
ZL-1310 is developed by Zai Lab Limited, which trades under the ticker ZLAB. Zai Lab is running the ZL-1310 clinical program, including a Phase 3 first-line extensive-stage small cell lung cancer study and a Phase 3 relapsed small cell lung cancer study called DLLEVATE.
ZL-1310 is in Phase 3 development. Two Phase 3 trials are registered, one in first-line extensive-stage small cell lung cancer and one in relapsed small cell lung cancer, alongside earlier-phase studies. ZL-1310 is investigational and is not approved; it holds FDA Orphan Drug and Fast Track designations.
ZL-1310 is in four registered trials. NCT07796100 is a Phase 3 study in first-line extensive-stage SCLC combining ZL-1310 with a checkpoint inhibitor versus standard of care. NCT07218146 (DLLEVATE) is a Phase 3 relapsed SCLC study. NCT07707895 tests ZL-1310 with obrixtamig, and NCT06885281 studies selected solid tumors.