alveltamig (ZG006) / Suzhou Zelgen - LARVOL DELTA

A phase II clinical study of dose optimization for ZG006 (Alveltamig) in patients with advanced small cell lung cancer who have received at least two prior lines of therapy (ZG006-002) (ESMO Asia 2025) - P1/2 | "ZG006 demonstrated a robust and durable response in relapsed/refractory SCLC with a manageable safety profile in both 10 mg and 30 mg groups. Given the longer PFS and DoR trend with a 6-month PFS rate at 53.1% and a 6-month DoR rate at 79.8%, and a reduced CRS rate, 10 mg Q2W was selected and advanced into registration studies which are currently underway. Our study highlights the best-in-class potential of ZG006 among DLL3 targeted TCE under clinical development."

Clinical • Late-breaking abstract • Metastases • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Thoracic Cancer • DLL3

Study of ZGGS34 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=400 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1/2 trial • Solid Tumor

Zai Lab…announced that its investigational product, ZG006 for injection, has been included in the list of breakthrough therapy products by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. [Google translation] (Zhitong Finance) - "The indication for ZG006 monotherapy is for patients with DLL3-positive advanced neuroendocrine carcinoma who have relapsed or progressed after at least platinum-based treatment."

Breakthrough therapy • Neuroendocrine Carcinoma

Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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

ZG006-002: 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=265 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | N=105 ➔ 265

Enrollment change • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Suzhou Zelgen Says ZG006 Has Received Orphan Drug Designation From U.S. FDA (TradingView)

Orphan drug • Neuroendocrine Carcinoma

Suzhou Zelgen Secures NMPA Trial Approval for ZG006 (Alveltamig) – First‑In‑Class Trispecific Antibody for Advanced Neuroendocrine Carcinoma (flcube.com) - "Approval Type: Clinical‑trial authorization (Phase I/II)."

New P1/2 trial • Neuroendocrine Carcinoma

A phase I dose escalation and expansion study of ZG006, a trispecific T cell engager targeting DLL3/DLL3/CD3, as monotherapy in patients with refractory small cell lung cancer (SCLC) or neuroendocrine carcinoma (NEC) (ESMO 2025) - "The immunogenicity was very low, and ADA had no impact on PK. Conclusions ZG006 has demonstrated favorable safety and robust efficacy across several dose levels in patients with advanced SCLC or NEC."

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

A phase II dose expansion study of ZG006, a trispecific T cell engager targeting DLL3/DLL3/CD3, as monotherapy in patients with refractory neuroendocrine carcinoma (ESMO 2025) - "Conclusions ZG006 demonstrated encouraging antitumor activity and a manageable safety profile in previously treated NEC patients, with higher response rates observed at the 30 mg dose. These findings warrant further investigation of ZG006 as a potential treatment option in refractory NEC."

Clinical • Monotherapy • P2 data • Trispecific • Cervical Cancer • Colorectal Cancer • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor • DLL3

Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=420 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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

ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma (clinicaltrials.gov) - P1/2 | N=350 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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

Study of ZG006 in Participants With Neuroendocrine Prostate Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P2 trial • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor

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