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

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

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

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

JSKN003 FOR THE TREATMENT OF GC/GEJ WAS GRANTED ODD BY THE U.S. FDA (HKEXnews) - "The board (the 'Board') of directors (the 'Directors') of the Company is pleased to announce that JSKN003 has been granted Orphan Drug Designation ('ODD') by the U.S. Food and Drug Administration (the 'FDA') for the treatment of gastric cancer and gastroesophageal junction cancer ('GC/GEJ')."

Orphan drug • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

A biparatopic HER2-targeting ADC constructed via site-specific glycan conjugation exhibits superior stability, safety, and efficacy. (PubMed, RSC Chem Biol) - "JSKN003 retained its cytotoxic activity against trastuzumab-resistant cells, attributed to efficient payload delivery and blockade of downstream HER2 signaling pathways, demonstrating the potential to overcome clinical trastuzumab resistance. JSKN003 demonstrated excellent antitumor activity and a favorable safety profile in clinical trials, highlighting its potential as a promising therapeutic option for patients with HER2-positive tumors. These findings suggest that JSKN003 could be a valuable therapeutic strategy with excellent efficacy and safety for HER2-expressing tumors in the clinical setting."

Journal • Oncology • HER-2

JSKN003, a biparatopic anti-HER2 antibody drug conjugate (ADC), in the treatment of platinum-resistant ovarian cancer (PROC): Updated findings from two clinical trials. (ASCO 2025) - P1, P1/2, P3 | "Median age was 59.0 years, 65.2% had ≥ 3 prior lines of systemic therapy, 80.4% and 63.0% had previously received bevacizumab and PARP inhibitor, 39.1% were classified as HER2-expressing (IHC: 1+/2+/3+), with 21.7%, 10.9% and 6.5% in 1+, 2+ and 3+, respectively; 45.7% as HER2-no-expressing (IHC: 0), and 15.2% had no tissue samples for assessment. The maturer updated efficacy data reveal that JSKN003 provided substantial improvement in ORR, as well as benefit in PFS and OS in heavily treated PROC, irrespective of HER2 expression. The well tolerated toxicity with long-term observation was consistent with prior experience. A confirmatory trial (NCT06751485) is ongoing in all comers at any HER2 expression level to further support JSKN003 as a treatment option in this population."

Clinical • Platinum resistant • Interstitial Lung Disease • Oncology • Ovarian Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

A pooled analysis of JSKN003, a biparatopic anti-HER2 antibody conjugate (ADC), in patients with advanced HER2-overexpressing (IHC 3+) gastrointestinal tumors. (ASCO 2025) - P1, P1/2 | "Most pts were heavily pretreated (37.5% had ≥3 lines of prior treatment; 45.0% received irinotecan; 67.5% received anti-HER2 therapy; 42.5% received IO therapy). JSKN003 demonstrated promising efficacy in heavily pretreated pts with advanced HER2-overexpressing gastrointestinal tumors, with a manageable and predictable safety profile."

Metastases • Retrospective data • Anemia • Colorectal Cancer • Esophageal Cancer • Fatigue • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Interstitial Lung Disease • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • BRAF

JSKN003, a biparatopic HER2-targeting ADC, in heavily pretreated HER2-positive breast cancer: A pooled analysis of early-phase studies. (ASCO 2025) - P1, P1/2 | "JSKN003 demonstrated promising efficacy and manageable safety in heavily pretreated HER2-positive breast cancer, including T-DXd-experienced patients. The biparatopic HER2 antibody design likely enhanced its binding efficiency and contributed to the observed clinical benefit. These findings support the planned Phase 3 trial to further evaluate its therapeutic potential."

Retrospective data • Anemia • Breast Cancer • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Neutropenia • Oncology • Ovarian Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

Alphamab Oncology Presented Multiple Clinical Data of Anti-HER2 Biparatopic ADC JSKN003 at the 2025 ASCO Annual Meeting (Yahoo Finance) - "Pooled results have demonstrated that JSKN003 monotherapy has promising efficacy signals in patients with PROC, and the efficacy was observed across patients with (IHC 1+/2+/3+) or without (IHC 0) HER2 expression, with or without prior bevacizumab and prior PARP inhibitor....With a median follow-up time of 9.3 months, 46 patients were efficacy evaluable. 42 patients (91.3%) exhibited tumor shrinkage. The objective response rate (ORR) was 63.0%, the median progression-free survival (PFS) was 7.7 months, and the 9-month overall survival (OS) rate was 89.9%. Efficacy was observed across different HER2-expression subgroups."

Platinum resistant • Retrospective data • Ovarian Cancer

JSKN003 Combined Treatment of HER2-positive Gastric Cancer (clinicaltrials.gov) - P2 | N=153 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P2 trial • Gastric Cancer • Oncology • Solid Tumor