alveltamig (ZG006) / Suzhou Zelgen, AbbVie - LARVOL DELTA

Updated Overall Survival Results from the Phase 1 Dose Escalation and Expansion Study of Alveltamig (ZG006), a Trispecific T Cell Engager Targeting DLL3/DLL3/CD3, as Monotherapy in Patients with Refractory Small Cell Lung Cancer or Neuroendocrine Carcinoma with Longer Follow Up (ESMO 2026) - No abstract available

Clinical • Monotherapy • P1 data • Trispecific • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • 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 randomized phase II dose optimization study for alveltamig (ZG006), a trispecific T-cell engager targeting DLL3/DLL3/CD3, as monotherapy in patients with refractory neuroendocrine carcinoma (ZG006-003). (ASCO 2026) - P1/2 | "ZG006 demonstrated a robust and durable response and a manageable safety profile in previously treated NEC pts, with superior efficacy observed at the 30 mg dose. The confirmed ORR of 56.3% and median PFS of 8.41 months in pts with ≥50% DLL3 positive tumor cells are particularly encouraging, and support further development of ZG006 for this patient population at the 30 mg dose."

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

Updated results of the phase 1 dose escalation and expansion study of alveltamig (ZG006), a trispecific T cell engager targeting DLL3/DLL3/CD3, as monotherapy in patients with refractory small cell lung cancer or neuroendocrine carcinoma. (ASCO 2026) - P1/2 | "With longer follow up from phase I study, ZG006 continued to demonstrate robust antitumor activity in the dose expansion cohorts including high ORR, longer DoR/PFS, and clinically meaningful survival benefits in patients with refractory SCLC. No new safety signal was encountered. These data support ongoing development of ZG006 as monotherapy and in combination with other modalities in SCLC."

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

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

Updated results of the randomized phase 2 dose optimization study of alveltamig (ZG006), a trispecific T cell engager targeting DLL3/DLL3/CD3, as monotherapy in patients with advanced small cell lung cancer. (ASCO 2026) - P1/2 | "With longer follow up, both ZG006 10 mg Q2W and 30 mg Q2W continued to demonstrate robust antitumor activity with a trend of longer DoR and OS in patients with relapsed or refractory SCLC. Subgroup analyses demonstrated consistent antitumor activity across key prognostic subgroups including those with baseline treated brain metastases, those with baseline liver metastases, and those who received multiple lines of prior systemic treatment. These results also support further development of ZG006 in SCLC with ongoing pivotal studies."

Clinical • Metastases • Monotherapy • P2 data • Trispecific • Lung Cancer • 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

A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma (clinicaltrials.gov) - P3 | N=240 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P3 trial • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor • DLL3

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

Enrollment open • Colorectal Cancer • Gastric Cancer • Oncology • Solid Tumor • HER-2 • MSI • MUC17

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 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2027 ➔ Dec 2028 | Trial primary completion date: Dec 2027 ➔ Dec 2028

Checkpoint inhibition • Enrollment open • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Markey Cancer Center treats 1st patient in US with new lung cancer therapy (Newswise) - "The first patient was treated in late October under the direction of Markey Cancer Center medical oncologist Zhonglin Hao, M.D., Ph.D....The Phase 1 trial is the first for ZG006 in the U.S., following a trial in China that showed the drug was well-tolerated among patients. The U.S. trial will enroll patients at six sites, with Markey being the first to open and treat a patient. Other sites, including Case Comprehensive Cancer Center, are preparing to open."

Trial status • Small Cell Lung Cancer

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

Enrollment open • 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 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • 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 | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Zelgen BioPharma…has reached a collaboration with an international pharmaceutical giant for the global development and commercialization of its core R&D product ZG006 (Alveltamig), with a potential total amount exceeding 1.2 billion US dollars (FUTU) - "AbbVie has obtained exclusive rights to develop and commercialize ZG006 outside the Greater China region (including mainland China, the Hong Kong Special Administrative Region, and the Macau Special Administrative Region), while Zelgen retains the rights to develop and commercialize ZG006 within the Greater China region. Under the agreement, Zelgen will receive an upfront payment of 100 million US dollars, as well as near-term milestone payments based on clinical progress and option-related payments up to 60 million US dollars."

Licensing / partnership • Solid Tumor

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

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