opamtistomig (LBL-024) / Leads Biolabs - LARVOL DELTA

A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)] (clinicaltrials.gov) - P2 | N=172 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Solid Tumor

A Phase Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2028 ➔ Dec 2028

Enrollment open • Platinum resistant • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor

LBL-024 DOSED FIRST PATIENT IN PHASE II TRIAL OF FIRST-LINE TREATMENT FOR HEPATOCELLULAR CARCINOMA (HKEXnews) - "The open-label, multi-center Phase II clinical study...is being conducted across multiple hospitals in China. The trial aims to evaluate the efficacy and safety of Opamtistomig in combination regimens for the first-line treatment of patients with hepatocellular carcinoma."

Trial status • Hepatocellular Cancer

LBL-024 DOSED FIRST PATIENT IN PHASE II TRIAL OF FIRST-LINE TREATMENT FOR BILIARY TRACT CANCER (HKEXnews) - "The open-label, multi-center Phase II clinical study...is being conducted across multiple hospitals in China. The trial aims to evaluate the efficacy and safety of Opamtistomig in combination regimens for the first-line treatment of patients with advanced biliary tract cancer."

Trial status • Biliary Tract Cancer

A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)] (clinicaltrials.gov) - P2 | N=172 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

New P2 trial • Hepatocellular Cancer • Solid Tumor

A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Melanoma • Oncology • Solid Tumor

LBL-024: ORR data from P2 trial (NCT06157827) 1L EP-NEC in H2 2025 (Leads Biolabs) - H1 2025 Results: ORR data from P2 trial for 1L SCLC in Q4 2025/Q1 2026 and OS data in mid-2026

P2 data • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer

LBL-024: Regulatory submission in China for 3L+ extra-pulmonary neuroendocrine carcinoma in Q3 2026 (Leads Biolabs) - H1 2025 Results: Approval in China for 3L+ extra-pulmonary neuroendocrine carcinoma in mid-2027; Regulatory submissions in China for 1L extra-pulmonary neuroendocrine carcinoma and 1L SCLC in combination with chemotherapy in 2029; Regulatory submission in China for NSCLC and other solid tumors in 2030

China approval • China filing • Neuroendocrine Carcinoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

LBL-024: ORR data from P1b/2 trial (NCT05170958) for 3L + EP-NEC in H1 2026 and OS data in H2 2026 (Leads Biolabs) - H1 2025 Results: ORR data for 2L + EP-NEC in H2 2026 and OS data in H2 2026

P1/2 data • Neuroendocrine Carcinoma • Oncology

LBL-024: “LBL-024 – Monotherapy phase I/II- efficacy results in EP-NEC (2/3)”; Extra pulmonary neuroendocrine carcinoma (Leads Biolabs) - H1 2025 Results: “LBL-024 in combination with chemotherapy – Ph Ib/II 1L EP-NEC”

P1/2 data • Neuroendocrine Carcinoma • Oncology

Nanjing Leads Biolabs…announced the first patient has been successfully dosed in a Phase 1b/II clinical trial (NCT07099430) evaluating Opamtistomig…as monotherapy or in combination with other agents for the ‌first-line treatment of advanced melanoma‌‌ (PRNewswire)

Trial status • Melanoma

LBL-024: “LBL-024 in combination with chemotherapy – Phase II 1L SCLC”; Small cell lung cancer (Leads Biolabs) - H1 2025 Results: “As of June 5, 2025, among 52 evaluable patients, ORR of 86.5% (45/52) and DCR of 96.2% (50/52) were observed in the 1L SCLC cohort in the Phase II trial”

P2 data • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer

A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=200 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

Monotherapy • New P1/2 trial • Melanoma • Oncology • Solid Tumor

Leads Biolabs Announces Completion of Patient Enrollment in Pivotal Trial of Opamtistomig Monotherapy for Extrapulmonary Neuroendocrine Carcinoma (PRNewswire) - "Nanjing Leads Biolabs...announced the successful completion of patient enrollment in the ongoing single-arm, pivotal registrational clinical trial (CTR20213023) for Opamtistomig (LBL-024), a novel PD-L1/4-1BB bispecific antibody."

Enrollment closed • Neuroendocrine Carcinoma

A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)] (clinicaltrials.gov) - P2 | N=210 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase Ib/Ⅱ Trial of LBL-024 in Combination With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=110 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

New P1/2 trial • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Assessment of efficacy of LBL-024, a novel and uniquely designed bispecific antibody against PD-L1 and 4-1BB, combined with etoposide/platinum-based chemotherapy in treatment-naive advanced extrapulmonary neuroendocrine carcinoma (EP-NEC): A multicenter phase Ib/II trial. (ASCO 2025) - P1/2 | "Here we report the safety and efficacy of LBL-024 combined with etoposide and cisplatin or carboplatin (EP/EC) as first line treatment in patients with advanced NEC. LBL-024 combined with chemotherapy was well-tolerated. The extremely improved response observed in EP-NECs is significantly higher than the historic reports (about 30%~55%). Data including ER analysis of this ongoing study will be updated by a follow-up submission to ASCO."

Clinical • Metastases • P1/2 data • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • PD-L1

Breakthrough Clinical Data for LBL-024 in First-Line Treatment of Advanced EP-NEC Unveiled at 2025 ASCO Oral Session (PRNewswire) - P1b/2 | N=178 | NCT06157827 | Sponsor: Nanjing Leads Biolabs Co.,Ltd | "In 52 efficacy-evaluable patients, the overall response rate (ORR) across all dose levels was 75.0% and the disease control rate (DCR) was 92.3%, significantly outperforming historical ORR data (30%-55%) with chemotherapy alone. The 15 mg/kg in dose optimization demonstrated the strongest anti-tumor activity, achieving an ORR of 83.3% and a DCR of 100%. 57.7% (30/52) of the patients experienced >50% tumor shrinkage. As of April 15th, 2025, with a median follow-up of 8.2 months, progression-free survival (PFS) data remains immature, but trends indicate promising durability across all the dose groups. In the phase Ib dose escalation stage, no dose-limiting toxicities (DLTs) were observed."

P1/2 data • Neuroendocrine Tumor

2025 ASCO: Encouraging Clinical Data from Leads Biolabs' Innovative Bispecific Antibody LBL-024 against PD-L1 and 4-1BB Selected for Oral Presentation (Leads Biolabs Press Release) - "Nanjing Leads Biolabs Co., Ltd...announced that two of its innovative oncology assets, LBL-024 and LBL-007, have been selected for oral and poster presentations, respectively, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago from May 30 to June 3. The selection highlights the strong clinical potential and innovation of Leads Biolabs’ immuno-oncology pipeline."

Clinical data • Nasopharyngeal Carcinoma • Neuroendocrine Tumor

A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)] (clinicaltrials.gov) - P2 | N=210 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

FDA Granted Orphan Drug Designation of LBL-024, An Anti-PD-L1/4-1BB Bispecific Antibody Developed by Leads Biolabs, for Treatment of Neuroendocrine Cancer (PRNewswire) - "Nanjing Leads Biolabs...announced that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by the company with global intellectual property rights for the treatment of neuroendocrine cancer, has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). This marks another significant milestone following the Breakthrough Therapy Designation granted to LBL-024 by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) in China...These policy supports for obtaining Orphan Drug qualification will greatly expedite the commercialization of LBL-024, potentially changing the treatment landscape for patients with advanced neuroendocrine cancer who currently have few therapeutic options."

Orphan drug • Neuroendocrine Tumor

The CDE has Granted Breakthrough Therapy Designation to LBL-024, a Bispecific Antibody that Targets PD-L1 and 4-1BB, Developed by Leads Biolabs, for the Treatment of Extrapulmonary Neuroendocrine Carcinoma. (PRNewswire) - "Nanjing Leads Biolabs Co., Ltd...announced that Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation to LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by Leads Biolabs with global intellectual property rights, for the treatment of the patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) who have progressed after receiving two or more lines of chemotherapy. The Breakthrough Therapy Designation awarded to LBL-024 stems from its remarkable clinical efficacy and safety profile in patients with advanced EP-NEC who failed in second-line and above chemotherapy."

Breakthrough therapy • Neuroendocrine Tumor • Oncology • Solid Tumor

Phase I/II clinical study of LBL-024, a bispecific antibody targeting PD-L1 and 4-1BB, in patients with advanced malignancies and neuroendocrine cancer (CSCO 2024) - "Study group: [Organizing Committee]"

Clinical • Metastases • P1/2 data • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Two studies were presented at the CSCO conference! Weilizhibo’s innovative drug clinical research has made another major achievement [Google translation] (bydrug.pharmcube.com) - P1/2a | N=396 | NCT05170958 | Sponsor: Nanjing Leads Biolabs Co.,Ltd | "The LBL-024 Phase I/II clinical study (NCT05170958) was led by Professor Shen Lin from Beijing Cancer Hospital and conducted in 24 centers across the country to evaluate the safety and efficacy of LBL-024 monotherapy in patients with advanced malignant tumors. The research data released this time showed....In a Phase I/II study, the objective response rate (ORR) of 45 patients with extrapulmonary neuroendocrine carcinoma (EP-NEC) was 33.3%, more than double the existing treatment....LBL-024 showed significant anti-tumor effects and good safety in EP-NEC patients. The observed ORR was significantly higher than the historical data of immunotherapy monotherapy and FOLFIRI chemotherapy, which will support its pivotal research in EP-NEC indications."

P1/2 data • Neuroendocrine Tumor

Weilizhibo's PD-L1/4-1BB dual antibody is planned to be included in the breakthrough therapy category for this rare lung cancer [Google translation] (Sohu.com) - "On September 25, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that LBL-024 for injection, which was applied by Wellizbo, is planned to be included in the breakthrough therapy category. The indication is monotherapy for patients with advanced extrapulmonary neuroendocrine carcinoma who have progressed after two or more lines of chemotherapy."

Breakthrough therapy • Neuroendocrine Tumor