JSKN016 / Alphamab - LARVOL DELTA

Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

JSKN016:…Expected Milestones in 2025 (PRNewswire-Asia) - "(i) Initiate patient enrollment in the clinical trial of JSKN016 in combination with IO and chemotherapy as first-line treatment for wild-type NSCLC; (ii) File an application with the CDE for one to two pivotal clinical studies of JSKN016; (iii) File an application with the CDE for BTD for one to two indications of JSKN016; (iv) Release HER2-negative BC related clinical data."

New trial • Non-US regulatory • P1/2 data • Trial status • HER2 Negative Breast Cancer • Non Small Cell Lung Cancer

JSKN016:…Events during the Reporting Period (PRNewswire-Asia) - "Enrollment has been completed in the cohort expansion clinical study of JSKN016 monotherapy in HER2-negative BC....The phase II clinical study of JSKN016 monotherapy in multiple cohorts of...NSCLC to evaluate efficacy, safety, and dose optimization is currently being conducted. Enrollment has been completed for both the cohorts of second-line and third-line treatment for EGFR-mutant patients."

Enrollment status • HER2 Negative Breast Cancer • Non Small Cell Lung Cancer

First-in-human study of JSKN016, a bispecific anti-TROP2/HER3 antibody drug conjugate (ADC): Antitumor activity in patients (pts) with metastatic triple-negative breast cancer (mTNBC) and safety results. (ASCO 2025) - P1 | "JSKN016 demonstrated an excellent antitumor activity in heavily pretreated TNBC, with a manageable and predictable safety profile. Efficacy Findings"

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Dermatitis • Dermatology • Immunology • Interstitial Lung Disease • Mucositis • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • Triple Negative Breast Cancer • ERBB3

Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=180 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

Alphamab Oncology Reports Full Year 2024 Financial Results and Business Highlights (GlobeNewswire) - "In March 2025, IND application for JSKN016 combined with chemotherapy/immunotherapy /tyrosine kinase inhibitors (TKI) as first-line and later-line treatment of multiple subgroups of non-small cell lung cancer (NSCLC) was approved by CDE; In March 2025, IND application for JSKN016 combined with chemotherapy/immunotherapy as first-line and later-line treatment of multiple subgroups of non-HER2-positive BC was approved by CDE."

New trial • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer

Evaluation of JSKN016 Combination Therapy in Subjects with NSCLC (clinicaltrials.gov) - P1 | N=288 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

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

Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study (clinicaltrials.gov) - P2 | N=220 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

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

To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Metastases • New P1 trial • Oncology • Solid Tumor

Alphamab-B (09966): Phase I clinical trial of JSKN016 for the treatment of advanced malignant solid tumors completed the administration of the first patient [Google translation] (Sina Corp) - "Alphamab-B...announced that JSKN016...Phase I clinical trial in China successfully completed the administration of the first patient. The clinical trial is an open-label, multi-center, first-in-human, dose-escalation and dose-expansion Phase I clinical trial. The clinical trial aims to evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK) and immune plausibility of JSKN016 in patients with advanced malignant solid tumors, and to determine the maximum efficacy of JSKN016 in patients with advanced malignant solid tumors. tolerated dose (MTD) and/or recommended phase II dose (RP2D). This clinical trial plans to enroll a total of approximately 80 to 140 patients."

Trial status • Oncology • Solid Tumor

Alphamab Oncology Announced Innovative Bispecific Antibody Coupling Drug JSKN016 Clinical Study Accepted by CDE (Alphamab Press Release) - "Alphamab Oncology...announced an application for clinical trial of JSKN016, a new generation of bispecific antibody ADC drug, was officially accepted by CDE and will carry out clinical research on the treatment of advanced malignant solid tumors....This is the first global clinical study of JSKN016 to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of JSKN016 in Chinese subjects with advanced malignant solid tumors."

New trial • Oncology • Solid Tumor