alveltamig (ZG006) / Suzhou Zelgen - LARVOL DELTA

A phase 2 dose expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced neuroendocrine carcinoma. (ASCO 2025) - P1/2 | "With a limited data, ZG006 exhibited an anti-tumor activity trend in NEC pts who failed to prior standard treatments. The safety profiles were generally similar to those observed in the ZG006 Phase 1 dose escalation study."

Clinical • Metastases • Monotherapy • P2 data • Trispecific • Anemia • Cervical Cancer • Colorectal Cancer • Endocrine Cancer • Hypertension • Lung Cancer • Metabolic Disorders • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A phase 1 dose escalation and expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with refractory small cell lung cancer or neuroendocrine carcinoma. (ASCO 2025) - P1/2 | "ZG006 exhibited a promising antitumor activity with acceptable safety profiles. Phase 2 dose expansion studies have been initiated to further investigate the efficacy and safety of ZG006 in pts with SCLC or NEC."

Clinical • Monotherapy • P1 data • Trispecific • Anemia • Constipation • Dermatology • Endocrine Cancer • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Lung Cancer • Neuroendocrine Tumor • Oncology • Pneumonia • Pruritus • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • DLL3

A phase 2 dose expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer. (ASCO 2025) - P1/2 | "ZG006 exhibited promising efficacy and acceptable safety in SCLC pts receiving ≥2 lines of prior treatment, even in pts with low DLL3 expression. The enrollment of ZG006-002 study is ongoing."

Clinical • Metastases • Monotherapy • P2 data • Trispecific • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2024 ➔ Mar 2025

Enrollment open • Trial initiation date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Zelgen Pharmaceuticals' ZG006 for injection in combination with PD-1/PD-L1 immune checkpoint inhibitors approved for clinical trial [Google translation] (MSN News) - "Beijing Business Daily...On the evening of April 20, Zejing Pharmaceutical (688266) issued an announcement stating that the company recently received the 'Drug Clinical Trial Approval Notice' approved and issued by the National Medical Products Administration. The clinical trial of ZG006 for injection combined with PD-1/PD-L1 immune checkpoint inhibitors for small cell lung cancer was approved."

New trial • Small Cell Lung Cancer

Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=105 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2024 ➔ Sep 2024

Enrollment open • Metastases • Trial initiation date • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma. (clinicaltrials.gov) - P1/2 | N=78 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Results from a phase I first-in-human study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer or neuroendocrine carcinoma (CSCO 2024) - "Study Group: [Organizing Committee]"

Clinical • Metastases • Monotherapy • P1 data • Trispecific • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Phase 1 Dose Escalation Study of ZG006 in Patients with Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Preliminary phase I results from a first-in-human study of ZG006, a trispecific anti-T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer or neuroendocrine carcinoma (ESMO 2024) - P1/2 | "Tumor response was assessed by RECIST1.1. Pharmacokinetics and DLL3 expressions were also assessed in this study."

Clinical • Metastases • Monotherapy • P1 data • Trispecific • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Zelgen Pharmaceuticals (688266.SH): ZG006 for injection obtains FDA orphan drug designation [Google translation] (Zhitong Finance) - "According to the Zhitong Finance APP, Zejing Pharmaceutical (688266.SH) issued an announcement that recently, the company's product under development, ZG006 for injection, has obtained Orphan-drug Designation from the U.S. Food and Drug Administration (hereinafter referred to as 'FDA') for the treatment of small cell lung cancer. After obtaining the orphan drug qualification, the company still needs to communicate and negotiate with the FDA on the follow-up clinical trials and registration application plan for ZG006 for injection for the treatment of small cell lung cancer."

Orphan drug • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma. (clinicaltrials.gov) - P1/2 | N=78 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Metastases • New P1/2 trial • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=105 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1/2 trial • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma (clinicaltrials.gov) - P1/2 | N=54 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma (clinicaltrials.gov) - P1/2 | N=54 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1/2 trial • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3