Investigational Drug
ZL-1310
TrialFetch AI Analysis
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Overview
Zocilurtatug pelitecan (ZL-1310) is an investigational antibody–drug conjugate being studied in previously treated extensive-stage small-cell lung cancer (SCLC) and other neuroendocrine carcinomas. Human results are available from early-phase, single-arm trials; a randomized phase 3 SCLC trial is underway, but it has not reported comparative results. (ascopubs.org)
Mechanism of action
ZL-1310 pairs an antibody targeting DLL3—a protein expressed in many neuroendocrine tumors—with a topoisomerase I inhibitor payload. A protease-cleavable linker connects the two. (aacrjournals.org)
Efficacy
In a 2025 phase 1 SCLC dose-escalation analysis, 19 of 28 patients (68%) had an objective response, including one awaiting confirmation. In a later company-reported analysis, the response rate was 68% among 19 second-line patients receiving 1.6 mg/kg; the estimated median response duration across doses and treatment lines was 6.1 months. These are small, uncontrolled groups, not estimates of benefit versus standard treatment. (ascopubs.org)
A 2026 update reported confirmed intracranial responses in 22 of 41 evaluable patients (53.7%) with SCLC brain metastases. In a separate neuroendocrine-carcinoma study, the company reported confirmed responses in 13 of 34 evaluable patients (38.2%); the published conference abstract describes an earlier analysis with fewer patients. (zailab.gcs-web.com)
Safety
In the 2026 SCLC update, 27 of 136 patients (19.9%) had grade 3 or higher treatment-related adverse events. The most frequently reported were neutropenia (9.6%) and anemia (8.8%). In the earlier neuroendocrine-carcinoma conference abstract, one of 28 patients discontinued treatment after grade 2 interstitial lung disease. Longer follow-up and randomized data are needed to characterize risks more fully. (zailab.gcs-web.com)
Further reading
- 2025 SCLC phase 1 conference abstract
- 2026 neuroendocrine-carcinoma conference abstract
- 2026 SCLC brain-metastasis conference abstract
- Phase 3 trial design abstract
Last updated: Sep 2026
Active trials using ZL-1310
Found 3 active trials using this drug:
TrialFetch AI summary: Adults with measurable SCLC and ECOG 0–1 are eligible after progression or recurrence on platinum-based therapy; a separate cohort enrolls patients with extensive-stage SCLC who have received no more than one cycle of platinum chemotherapy. All receive tarlatamab, a DLL3-directed T-cell engager, plus ZL-1310, a DLL3-targeted antibody–drug conjugate carrying a topoisomerase I inhibitor; the extensive-stage cohort also receives durvalumab (anti-PD-L1).
ClinicalTrials.gov ID: NCT07531095
TrialFetch AI summary: Adults with measurable small-cell lung cancer that progressed during or after platinum-based therapy and ECOG performance status 0–1 are randomized to ZL-1310 or investigator’s choice therapy. ZL-1310 is a DLL3-targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor payload; prior tarlatamab is permitted, but prior ADCs with a topoisomerase I inhibitor payload are excluded.
ClinicalTrials.gov ID: NCT07218146
TrialFetch AI summary: This study enrolls adults with extensive-stage or metastatic SCLC, including previously treated patients, treatment-naive patients, and patients with disease control after first-line therapy, depending on the cohort. It evaluates the DLL3-targeting antibody–drug conjugate ZL-1310, which delivers a topoisomerase I inhibitor, alone or with atezolizumab, with some cohorts also receiving carboplatin induction.
ClinicalTrials.gov ID: NCT06179069
