anbenitamab repodatecan (JSKN003) / Alphamab, CSPC Pharma - LARVOL DELTA

Recent advances in bispecific antibody-drug conjugates for breast cancer therapy. (PubMed, Cancer Chemother Pharmacol) - "BsADCs are a transformative therapeutic modality for breast cancer. Their ability to enhance tumor selectivity, overcome heterogeneity, and target resistant pathways positions them as key players in the future oncology landscape, with ongoing trials poised to define their clinical role."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD63 • EGFR • ERBB3 • HER-2

JSKN003-102: Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=725 | Active, not recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Trial primary completion date: Dec 2025 ➔ Jul 2026

Trial primary completion date • Oncology • Solid Tumor

Biparatopic anti-HER2 antibody drug conjugate (ADC) JSKN003 in the treatment of primary platinum-refractory ovarian cancer (OC) (ESMO 2025) - P1/2 | "The median age was 52.0 years, 33.3% had ≥ 3 prior lines of systemic therapy, 81.0% and 28.6% had previously received bevacizumab and PARP inhibitors, respectively, 28.6% were categorized as HER2-expressing (IHC: 1+/2+/3+), with 19.0%, 4.8% and 4.8% in 1+, 2+ and 3+ subgroups, respectively; 52.4% as HER2-no-expressing (IHC: 0), and 19.0% were unevaluable. No interstitial lung disease was observed. Conclusions JSKN003 demonstrated promising efficacy and tolerability in primary platinum-refractory OC, a patient population with limited treatment options."

Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • HER-2

JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan (clinicaltrials.gov) - P3 | N=123 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P3 trial • Colorectal Cancer • Oncology • Solid Tumor • HER-2 • MSI

Safety and efficacy of JSKN003 in patients with advanced/metastatic solid tumors: A first-in-human, dose-escalation, multicenter, open-label, phase I study. (ASCO 2024) - P1 | "JSKN003 was well tolerated with encouraging preliminary antitumor activity in heavily pretreated pts with advanced/metastatic solid tumors, especially in pts with HER2 expressed tumors. As of the cut-off date, no DLT was observed, MTD has not been reached yet."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • HER-2

Evaluation of the safety, pharmacokinetics, and efficacy of JSKN003 in patients with advanced solid tumors: A phase I/II clinical study. (ASCO 2024) - P1/2 | "MTD of JSKN003 was not reached yet. And safety of JSKN003 was extremely excellent with encouraging preliminary antitumor activity in heavily pretreated pts with advanced solid tumors."

Clinical • Metastases • P1/2 data • PK/PD data • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Lung Cancer • Neutropenia • Oncology • Ovarian Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor

JSKN033, an innovative subcutaneous-injected fixed-dose combination (FDC) of biparatopic anti-HER2 antibody drug conjugate (ADC) and PD-L1 inhibitor in advanced solid tumor (SITC 2024) - P1/2 | "Subcutaneous (SC) delivery offers a safer alternative, with comparable efficacy to intravenous delivery, as demonstrated by treatments like amivantamab. JSKN033 is a FDC for SC injection, utilizing innovative technology, comprising JSKN003, a biparatopic HER2-directed ADC, and KN035, a NMPA-approved PD-L1 inhibitor...These results encourage further clinical development of JSKN033. Additionally, the formulation technology may be applicable to other ADC therapies.View this table:View inline View popup Download powerpoint Abstract 1496 Table 1"

IO biomarker • Late-breaking abstract • Metastases • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Salivary Gland Cancer • Solid Tumor

Alphamab Oncology Announces Biparatopic HER2-targeting ADC JSKN003 Was Granted Breakthrough Therapy Designation by the FDA for the Treatment of PROC (PRNewswire) - "The grant of BTD for JSKN003 is based on the pooled analysis of the phase I clinical study in Australia (JSKN003-101, NCT05494918) and the phase I/II clinical study in China (JSKN003-102, NCT05744427)."

Breakthrough therapy • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

Adverse events induced by the subcutaneous HER2-targeted antibody-drug conjugate JSKN033 in a male patient with breast cancer: A case report. (PubMed, Oncol Lett) - "JSKN033 is a fixed-dose combination of JSKN003 [a biparatopic HER2-directed antibody-drug conjugate (ADC)] and envafolimab (a programmed death-ligand 1 inhibitor)...The present report highlights the case of a male patient with breast cancer with HER2 2+ expression who experienced disease progression after multiline therapy, including modified radical mastectomy, adjuvant chemotherapy, adjuvant radiotherapy and trastuzumab emtansine. Following enrollment in the JSKN033 clinical trial, the patient developed systemic and localized adverse reactions after treatment, including fatigue, diarrhea and injection-site reactions, such as pruritus, pain, skin indentation and induration. The present case report discusses potential etiologies of these adverse events and issues to consider during subcutaneous administration of HER2-directed ADCs, and provides supplementary clinical data to potentially advance the understanding of their adverse event profiles, mechanisms, prevention and..."

Adverse events • Journal • Breast Cancer • Dermatology • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Pruritus • Solid Tumor

Clinical Study on Pathological Remission and Safety of JSKN003 Combined with KN046 New Adjuvant Therapy for muscle-invasive bladder cancer (ChiCTR) - P=N/A | N=20 | Recruiting | Sponsor: harbin medical university cancer hospital; harbin medical university cancer hospital

New trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Phase III study of JSKN003, a biparatopic anti-HER2 antibody-drug conjugate (ADC), versus physician's choice of chemotherapy in platinum-resistant ovarian cancer (PROC) (ESMO 2025) - P3 | "Enrolled patients receive either JSKN003 6.3 mg/kg, Q3W or physician's choice of chemotherapy (paclitaxel 80 mg/m 2 , QW; liposomal doxorubicin 40 mg/m 2 , Q4W; or topotecan 4 mg/m 2 Day 1, 8, 15, Q4W, or 1.25 mg/m 2 Day 1-5, Q3W). Other secondary endpoints include overall response, duration of response, disease control rate, CA-125 response by GCIG criteria, adverse events, patient-reported quality of life, pharmacokinetics, and immunogenicity. This study is currently open for enrollment."

P3 data • Platinum resistant • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor • HER-2 • MUC16

Title: Biparatopic anti-HER2 antibody drug conjugate (ADC) JSKN003 in the treatment of primary platinum-refractory ovarian cancer (OC) (Alphamab Press Release) - "As of June 13, 2025, a total of 26 patients with primary platinum-refractory OC were enrolled....As of June 13, 2025, 25 patients were efficacy evaluable. The overall response rate (ORR) was 32.0%, the disease control rate (DCR) was 72.0%, the median progression-free survival (PFS) was 4.1 months, and the 9-month overall survival (OS) rate was 65.4%. Efficacy was observed across different HER2 expression subgroups."

P1/2 data • Ovarian Cancer

Title: Phase III study of JSKN003, a biparatopic anti-HER2 antibody-drug conjugate (ADC), versus physician’s choice of chemotherapy in platinum-resistant ovarian cancer (PROC): JSKN003-306 (Alphamab Press Release) - "JSKN003-306 (NCT06751485) is randomized, open-label, parallel-controlled, multi-center Phase III clinical study, enrolling patients with recurrent platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer, irrespective of HER2 expression....The JSKN003-306 study plans to enroll 556 patients across 80 sites in China. The first patient was successfully dosed in February 2025, and the study is currently in the patient enrollment phase."

Platinum resistant • Trial status • Ovarian Cancer

Alphamab Oncology Announces Biparatopic HER2-targeting ADC JSKN003 Was Granted Fast Track Designation by FDA for the Treatment of PROC (PRNewswire) - "The grant of FTD is based on the promising clinical data of JSKN003. The Company has presented a pooled analysis of the phase I clinical study in Australia (JSKN003-101, NCT05494918) and the phase I/II clinical study in China (JSKN003-102, NCT05744427) at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO)."

Fast track • Platinum resistant • Ovarian Cancer

Title: Efficacy and Safety of JSKN003, a Biparatopic anti-HER2 Antibody Drug Conjugate (ADC), in Patients with HER2-positive Metastatic Colorectal Cancer (mCRC) (Alphamab Press Release) - "As of June 30, 2025, a total of 33 patients with HER2-positive mCRC were enrolled....32 patients were efficacy evaluable. The ORR was 68.8%, the DCR was 96.9%. Additionally, among 31 BRAF V600E wild-type patients, the ORR was 71.0%, the DCR was 100%, and median duration of response (DoR) was 9.89 months (95%CI, 5.78 to NE), the median PFS achieved 11.04 months (95%CI, 6.9 to 14.03), with a 9-month PFS rate of 66.6%."

P1/2 data • Colorectal Cancer

Alphamab Oncology…has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a Phase III clinical study (Study ID: JSKN003-005) for the treatment of HER2-positive advanced colorectal cancer (CRC) (Alphamab Press Release) - "JSKN003-005 is a randomized, open-label, controlled, multicenter Phase III clinical study designed to evaluate the efficacy and safety of JSKN003 versus investigator's choice of regimen (regorafenib/fruquintinib/trifluridine tipiracil) in HER2-positive advanced CRC patients who have failed prior oxaliplatin, fluorouracil, and irinotecan therapy."

New P3 trial • Colorectal Cancer

Efficacy and safety of JSKN003: A biparatopic anti-HER2 antibody conjugate (ADC), in patients with HER2-positive metastatic colorectal cancer (mCRC) (ESMO 2025) - P1/2 | "Most pts were heavily pretreated (42.4% had ≥3 lines of prior treatment; 78.8% received irinotecan; 33.3% received anti-HER2 therapy; 18.2% received IO therapy). Interstitial lung disease (ILD) was observed in 3 (7.5%; n=2 G1; n=1 G2) pts. Conclusions JSKN003 demonstrated promising efficacy in pretreated HER2-positive mCRC pts, with a manageable safety profile."

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Biparatopic HER2-targeting ADC JSKN003 Was Granted Another Breakthrough Therapy Designation for HER2-Positive Advanced Colorectal Cancer (Alphamab Press Release) - "As of June 30, 2025, a total of 33 patients with HER2-positive advanced metastatic CRC, were enrolled and received JSKN003 monotherapy in a phase I (dose escalation and expansion) and phase II (cohort expansion) clinical study in China (JSKN003-102, NCT05744427), with 42.4% of these patients having previously received 3 or more prior lines of antitumor therapy."

Breakthrough therapy • Colorectal Cancer

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

JSKN003-102: Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=725 | Active, not recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2024 ➔ Dec 2025

Enrollment closed • Trial primary completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

JSKN003-302: JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting | Trial primary completion date: Apr 2025 ➔ Apr 2026

Enrollment open • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

JSKN003-101: First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors (clinicaltrials.gov) - P1 | N=62 | Completed | Sponsor: Alphamab (Australia) Co Pty Ltd. | Recruiting ➔ Completed | N=45 ➔ 62 | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Oct 2024 ➔ Apr 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Solid Tumor • HER-2

JSKN003:…Events after the Reporting Period (PRNewswire-Asia) - "In July 2025, two latest research results of JSKN003 for the treatment of primary platinum-refractory ovarian cancer (OC) and HER2-positive metastatic colorectal cancer (mCRC), along with the study design of the phase III study of JSKN003 versus physician's choice of chemotherapy in PROC, were accepted by the 2025 ESMO Congress and will be presented during the Congress in October."

Clinical data • Clinical protocol • Platinum resistant • Colorectal Cancer • Ovarian Cancer

JSKN003:…Expected Milestones in 2025 (PRNewswire-Asia) - "(i) Enrollment of all patients will be completed in the phase III clinical trial of JSKN003 versus trastuzumab emtansine (T-DM1) as second-line or above treatment for HER2-positive advanced BC; (ii) File an application with the CDE for one pivotal clinical study of JSKN003; (iii) File an application with the CDE for BTD for one indication of JSKN003."

Enrollment status • New trial • Non-US regulatory • HER2 Positive Breast Cancer

JSKN003 RECEIVED THE U.S. FDA APPROVAL TO INITIATE A PHASE II CLINICAL STUDY IN THE TREATMENT OF PROC NOT RESTRICTED BY HER2 EXPRESSION (HKEXnews) - "The board (the ‘Board’) of directors (the ‘Directors’) of the Company is pleased to announce that JSKN003 has received approval from the United States (‘U.S.’) Food and Drug Administration (‘FDA’) to initiate a phase II clinical study in the U.S. (study number: JSKN003-202). JSKN003-202 is a randomized, open-label, multi-center phase II clinical study of JSKN003 in the treatment of patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer (collectively referred to as platinum-resistant ovarian cancer, ‘PROC’) that not restricted by human epidermal growth factor receptor 2 (‘HER2’) expression. This clinical trial aims to evaluate the safety and efficacy and determine the recommended phase III dose."

IND • New P2 trial • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer