Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZL-1310 · 3 trials · 3 indications
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 |
|---|---|---|
| Arm 1 | EXPERIMENTAL | ZL-1310 as a single agent |
| Arm 2 | ACTIVE_COMPARATOR | Investigator's Choice of Therapy |
| 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 | DRUG | ZL-1310 as a single-agent |
| Investigator's Choice of Therapy | DRUG | Topotecan or Amrubicin |
| Atezolizumab | DRUG | Drug Atezolizumab |
| Carboplatin | DRUG | Drug Carboplatin |
Inclusion Criteria: * Age \>/= 18 years, or considered an adult by local regulations, at the time of consent * Signed informed consent * Histologically or cytologically confirmed SCLC. Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent...
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ZL-1310 is an investigational small molecule being developed for the treatment of small-cell lung cancer (SCLC) and selected solid tumors. It is currently in Phase 1 clinical trials for these indications, with studies recruiting participants in the United States, China, and Spain.
ZL-1310 targets DLL3, a protein that is expressed in certain cancer cells. By targeting DLL3, the drug aims to interfere with tumor growth. This mechanism is being studied in the context of small-cell lung cancer and other solid tumors.
ZL-1310 is being developed by Zai Lab Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ZLAB. The company is conducting clinical trials for this drug in multiple countries, including the United States and China.
ZL-1310 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Orphan Drug and Fast Track designations from the FDA for its potential use in small-cell lung cancer.
ZL-1310 is being studied in three clinical trials. NCT06179069 is a Phase 1 study in small-cell lung cancer with 339 participants. NCT06885281 is a Phase 1 study in selected solid tumors with 166 participants. NCT07218146 is a Phase 3 study in relapsed small-cell lung cancer with 480 participants.
ZL-1310 is also known as ZL-1310 in combination with Atezolizumab or Durvalumab. This name reflects ongoing research into combining the drug with these immunotherapies, although the clinical trials listed for ZL-1310 do not explicitly detail combination arms.