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, Lurbinectedin, 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...
Top 20 of 86 competitors