zocilurtatug pelitecan (ZL-1310) / ZAI Lab, MediLink - LARVOL DELTA

A Study of ZL-1310 in Participants With Selected Solid Tumors (clinicaltrials.gov) - P1/2 | N=86 | Recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

ZL-1310, a DLL3 ADC, in patients with extensive stage small cell lung cancer: Ph1 trial update. (ASCO 2025) - P1 | "ZL-1310 demonstrated a tolerable safety profile and promising antitumor activity in r/r ES-SCLC, including pts with brain metastases, pt with prior tarlatamab, and in the setting of low DLL3 expression. Updated data, including patients in the randomized Part 2 dose optimization, will be presented."

Clinical • IO biomarker • Anemia • Interstitial Lung Disease • Lung Cancer • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • DLL3

ZL-1310: “ZL-1310 demonstrated an acceptable safety profile with low rates of drug withdrawal and low-rates of high grade adverse events”; Small cell lung cancer (Zai Lab) - ASCO 2025: “ZL-1310 presented encouraging anti-tumor activity in patients with relapsed or recurrent ES-SCLC, including those with brain metastases”

P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer

Zai Lab Presents Positive Phase 1 Data for ZL-1310, a DLL3-Targeted ADC, Demonstrating Robust Anti-Tumor Activity and Safety in Patients with Extensive-Stage Small Cell Lung Cancer at 2025 ASCO Annual Meeting (Zai Lab Press Release) - P1a/1b | N=112 | NCT06179069 | Sponsor: Zai Lab (Shanghai) Co., Ltd. | "Clinically meaningful anti-tumor activity of ZL-1310 observed in heavily pretreated population of patients with small cell lung cancer (SCLC) across dose escalation and expansion cohorts; In second-line (2L) SCLC, objective response rate (ORR) was 67% across all dose levels (n=33) and 79% at 1.6 mg/kg dose (n=14); Median duration of response has not yet been reached, with 29 of 38 responders remaining on study; 27 of 31 patients with stable disease remaining on study, the majority of whom had tumor regressions; ZL-1310 demonstrated a well-tolerated safety profile at target doses of less than 2.0 mg/kg, with Grade ≥3 treatment-related adverse events (TRAEs) of 6%, and no drug discontinuations; Company plans to initiate pivotal trial in 2L SCLC with selected optimal dose later this year."

New P2 trial • P1 data • Small Cell Lung Cancer

ZL-1310: Regulatory filing in US for 2L SCLC in H2 2026 (Zai Lab) - ASCO 2025: Regulatory approval in US for 2L SCLC in H2 2027

FDA approval • FDA filing • Lung Cancer • Oncology • Small Cell Lung Cancer

ZL-1310: Data from P1 trial (NCT06179069) in combination with atezolizumab for 1L SCLC by end of 2025 (Zai Lab) - ASCO 2025

P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer

Zai Lab Receives U.S. FDA Fast Track Designation for ZL-1310, a DLL3-Targeted Antibody-Drug Conjugate, for Treatment of Extensive-Stage Small Cell Lung Cancer (Gurufocus) - "Zai Lab Limited (ZLAB, Financial) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its novel Delta-like ligand (DLL3) antibody-drug conjugate, ZL-1310, for treating extensive-stage small cell lung cancer (ES-SCLC)."

Fast track • Small Cell Lung Cancer

Zai Lab to Present Data from Phase 1 Trial of DLL3-Targeted Antibody-Drug Conjugate (ADC) ZL-1310 at 2025 ASCO Annual Meeting (Businesswire) - "Zai Lab Limited...announced that updated data from an ongoing, global Phase 1a/1b clinical trial (NCT06179069) evaluating ZL-1310, the Company’s potential first-in-class and best-in-class, Delta-like ligand (DLL3) antibody-drug conjugate (ADC) for the treatment of extensive-stage small cell lung cancer (ES-SCLC), will be presented during a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3, 2025 in Chicago, Illinois. The updated results will include additional patients and follow-up from the ongoing trial of ZL-1310 in patients with previously treated ES-SCLC after at least one prior platinum-based chemotherapy regimen."

P1 data • Small Cell Lung Cancer

A Phase Ib/II, Open-label, Multi-center Study of ZL-1310 in Participants with Selected Solid Tumors (clinicaltrials.gov) - P1/2 | N=86 | Not yet recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd.

New P1/2 trial • Neuroendocrine Tumor • Oncology • Solid Tumor

ZL-1310: Initiation of P3 trial for SCLC in 2025 (Zai Lab) - Q4 2024 Results

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer

Zai Lab Receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of Small Cell Lung Cancer (SCLC) (Businesswire) - "Zai Lab Limited...today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate (ADC), for the treatment of small cell lung cancer (SCLC)."

Orphan drug • Small Cell Lung Cancer

ZL-1310-001: A Study of ZL-1310 in Subjects With Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd. | Trial completion date: Dec 2027 ➔ Jul 2027

Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

ZL-1310: Initiation of P1 trial for neuroendocrine tumors in 2025 (Zai Lab) - Corporate Presentation

New P1 trial • Neuroendocrine Tumor • Oncology

DLL3-Targeted ADC Produces Responses in Previously Treated ES-SCLC (Cancer Network) - "'The preliminary results from the ongoing phase 1 trial of ZL-1310 suggest that this next-generation ADC therapy has the potential to deliver anti-tumor responses in the majority of patients with ES-SCLC, with good tolerability,' Alexander Spira MD, PhD...stated in the press release. 'This is particularly encouraging given the urgent need for improved treatment options for these patients. These promising data support continued evaluation of ZL-1310 as a monotherapy in the dose-expansion phase of the ongoing phase 1 clinical trial and in combination.'"

Media quote

Preliminary Results from a Phase Ia/Ib, Open-label, Multicenter Study of ZL-1310, a DLL3-targeted ADC, to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer - NCT06179069 (EORTC-NCI-AACR 2024) - P1 | "Preliminary results demonstrated ZL-1310 has a favorable PK and safety profile, with evidence of early clinical activity observed at the first dose level. The data support the continued dose escalation in SCLC and will be updated at presentation"

Clinical • P1 data • PK/PD data • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

ZL-1310, an Investigational DLL3-Targeted Antibody-Drug Conjugate (ADC), Demonstrates Promising Objective Response Rates and Safety Profile in Extensive-Stage Small Cell Lung Cancer (Businesswire) - P1 | N=112 | NCT06179069 | Sponsor: Zai Lab (Shanghai) Co., Ltd | "Data shared in the ENA presentation from the ongoing Part 1a monotherapy dose-escalation portion of the study included results from 25 patients across four dose cohorts (0.8 mg/kg, 1.6mg/kg, 2.0 mg/kg, and 2.4 mg/kg). Nineteen patients had evaluable tumor assessments...The ORR in patients with at least one post-treatment evaluation was 74% (95%CI, 48.8, 90.9). ZL-1310 anti-tumor activity was demonstrated across all dose levels; Responses were seen in patients with DLL3 H-scores from 5 (range: 5 to 260). No response was observed in a patient whose tumor did not express DLL3; ZL-1310 was well tolerated across all dose levels with the majority of treatment emergent adverse events (TEAE) being Grade 1 or 2."

P1 data • Small Cell Lung Cancer

Zai Lab to Host Webcast Presentation to Discuss Data from Early Clinical Program Evaluating Its Investigational DLL3-Targeted Antibody-Drug Conjugate (ADC) ZL-1310 (Businesswire) - "Zai Lab Limited...today announced that it will hold an investor webcast to discuss data from a Phase 1 clinical trial of ZL-1310, the Company’s investigational DLL3-targeted antibody-drug conjugate (ADC), in patients with advanced stage small cell lung cancer (SCLC). The live conference call and webcast will take place on Thursday, October 24, 2024, at 8:30 a.m. ET (8:30 p.m. HKT)."

P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Zai Lab to Present Data from Phase 1 Trial of ZL-1310, Its Investigational Antibody-Drug Conjugate (ADC) for DLL3+ Solid Tumors, at EORTC-NCI-AACR Symposium (ENA) 2024 (Businesswire) - "Zai Lab Limited...announced that data from a Phase 1 study of ZL-1310, the Company’s investigational antibody-drug conjugate (ADC), will be presented during a plenary session at the EORTC-NCI-AACR Symposium (ENA) 2024 taking place October 23-25, in Barcelona, Spain. The preliminary results from the ongoing, open-label, multicenter clinical trial (NCT06179069) will address the potential of ZL-1310 as a novel treatment for small cell lung cancer (SCLC)."

P1 data • Small Cell Lung Cancer

ZL-1310-001: A Study of ZL-1310 in Subjects With Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd. | N=85 ➔ 112

Enrollment change • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Zai Lab Announces Second Quarter 2024 Financial Results and Recent Corporate Updates (Businesswire) - "Expected Clinical Development and Data Readouts:...(i) ZL-1310 (DLL3 ADC): Potential dose escalation data from the global Phase 1 study in relapsed and refractory second-line+ SCLC at the end of 2024 or early 2025; (ii) ZL-1218 (CCR8): Present the preliminary clinical PK and PD analysis of the global Phase 1 study in solid tumors at 2024 European Society for Medical Oncology (ESMO) in September 2024."

P1 data • PK/PD data • Small Cell Lung Cancer

An Open-label, Multicenter Study of ZL-1310 in Subjects With Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=85 | Recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd. | N=140 ➔ 85

Enrollment change • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Zai Lab Announces First Quarter 2024 Financial Results and Recent Corporate Updates (Businesswire) - "Anticipated Major Milestones in 2024 - Oncology: (i) Repotrectinib: Potential NMPA approval of our NDA for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC; (ii) ZL-1310 (DLL3 ADC): Potential dose escalation data from the global Phase 1 study in relapsed and refractory second-line+ SCLC at the end of 2024 or early 2025."

Non-US regulatory • P1 data • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Trial in progress: A phase Ia/Ib, an open-label, multicenter study of ZL-1310 to evaluate the safety, tolerability, and pharmacokinetics in subjects with small cell lung cancer (AACR 2024) - "The major exclusion criteria include: (1) Prior exposure to DLL3-targeted therapy. (2) Subjects with symptomatic or uncontrolled brain metastasis requiring concurrent treatment, impaired major organ functions, active autoimmune disease, or active infections.Part 1 Dose Escalation is recruiting subjects in the US and China."

Clinical • P1 data • PK/PD data • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Zai Lab Presentations at AACR 2024 Annual Meeting to Showcase Ongoing Clinical Studies in Key Global Oncology Programs (Businesswire) - "Zai Lab Limited...announced that two poster presentations highlighting ongoing global clinical studies in its oncology pipeline will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024 taking place April 5-10, 2024, in San Diego, California. The global oncology programs to be showcased at AACR 2024 include a Phase 1a/1b study of ZL-1310 (NCT06179069), a novel antibody-drug conjugate (ADC) within the Zai Lab pipeline that targets the Delta-like ligand 3 (DLL3), a validated therapeutic target for the treatment of small cell lung cancer (SCLC)....Also featured at AACR 2024 will be Zai Lab’s Phase 1 study (NCT05859464) of ZL-1218, an anti-CCR8 antibody that blocks regulatory T cells (Treg) which suppress antitumor immunity in tumor tissue and is designed to deplete Treg cells selectively in tumors and minimally in other tissue."

Trial status • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Development and characterization of a novel DLL3-targeting antibody drug conjugate (ADC) for the treatment of solid tumors (ELCC 2024) - "Conclusions ZL-1310, a high-affinity humanized IgG1 mAb specific for DLL3, is conjugated with a novel payload and developed for the treatment of SCLC and other DLL3+solid tumors. Zai Lab has completed IND-enabling studies and received FDA clearance of its IND application for evaluating ZL-1310 in subjects with small cell lung cancer."

Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3