JSKN033 / Alphamab - LARVOL DELTA

JSKN033, a first-in-class subcutaneous (SC)-injected fixed-dose combination (FDC) of biparatopic anti-HER2 ADC and PD-L1 inhibitor, in pre-treated cervical cancer (ESMO 2026) - No abstract available

ADC • Cervical Cancer • Oncology • Solid Tumor

JSKN033 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=368 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P3 trial • Cervical Cancer • Oncology • 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

Subcutaneous administration of antibody-drug conjugates: current challenges, emerging opportunities, and future perspectives. (PubMed, Antib Ther) - "Recent advances, exemplified by JSKN033, demonstrate the feasibility of high-concentration liquid co-formulation approaches for SC administration and may represent a future direction. Evidence across oncology and non-oncology programs suggests that while SC delivery is achievable, success is highly molecule dependent. Overall, transitioning ADCs from IV to SC requires case-by-case evaluation and coordinated innovation across rational molecular design, formulation, and nonclinical and clinical development to realize the full patient-centric benefits of this approach."

Journal • Review • Oncology

Alphamab Oncology Announces CDE Approval for Phase III Study of JSKN033, First-in-Class HER2 Bispecific ADC Subcutaneous Co-formulation, in Cervical Cancer (Alphamab Press Release) - "JSKN033-301 is an open-label, randomize, controlled, multicenter Phase III study designed to assess the efficacy and safety of JSKN033 versus physician choice chemotherapy in patients with recurrent or metastatic cervical cancer who have progressed on or after IO and platinum-based chemotherapy."

New P3 trial • Cervical Cancer

JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer (clinicaltrials.gov) - P2 | N=78 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

JSKN033:…Expected Milestones in 2026 (from Q2 2026) (Alphamab Press Release) - "(i) The phase II clinical study of JSKN033 in combination regimens as first‑line treatment for CC will be initiated; (ii) Registrational clinical study of JSKN033 as later‑line treatment for CC (all‑comer) will be initiated."

New trial • Cervical Cancer

Alphamab Oncology Announces IND Application for a Phase II Clinical Study of HER2 Bispecific ADC Subcutaneous Co-formulation JSKN033 as First-line Treatment of Advanced Cervical Cancer was Officially Accepted by CDE (PRNewswire-Asia) - "JSKN033-202 is an open-label, multicenter phase II clinical trial designed to evaluate the safety, efficiency and pharmacokinetics (PK)/pharmacodynamics (PD) of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, as first-line treatment for patients with advanced cervical cancer."

New P2 trial • Cervical Cancer

A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

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

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

A Phase Il Clinical Study to Evaluate the Safety,Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung Cancer (ChiCTR) - P2 | N=160 | Not yet recruiting | Sponsor: Hunan Cancer Hospital; Hunan Cancer Hospital

IO biomarker • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors (clinicaltrials.gov) - P1/2 | N=11 | Terminated | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | N=30 ➔ 11 | Trial completion date: Oct 2026 ➔ Jul 2025 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2026 ➔ Jul 2025; the decision is based on a strategic realignment of our clinical trial priorities to optimize the overall development pathway for JSKN033

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Gastrointestinal Cancer • Solid Tumor

JSKN033:…Events during the Reporting Period (PRNewswire-Asia) - "(i) The phase II clinical study of JSKN033 in HER2-mutated or HER2-expressing NSCLC has been initiated; (ii) The dose escalation phase has been completed in the phase I/II clinical study in Australia of JSKN033 for the treatment of HER2-expressing advanced or metastatic solid tumors."

Trial status • Non Small Cell Lung Cancer

JSKN033:…Expected Milestones in 2025 (PRNewswire-Asia) - "File an application with the CDE for a phase II clinical study of JSKN033 in combination with chemotherapy."

New P2 trial • Oncology

Corning Oncology Pharmaceuticals-B rose 8% against the trend; the first successful administration of JSKN033 attracted attention [Google translation] (Sohu.com) - "Alphamab Oncology announced today that the first patient has been dosed in the Phase I/II clinical study of its novel HER2 bispecific antibody-drug conjugate (ADC) and PD-L1 inhibitor, JSKN033, a high-concentration subcutaneous injection combination (study number: JSKN033-102) in China at the Affiliated Cancer Hospital of Fudan University."

Trial status • Solid Tumor

JSKN033 in Chinese Subjects with Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=430 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P1/2 trial • Oncology • Solid Tumor

IND Application for a Phase I/II Clinical Study of Anti-HER2 Bispecific ADC Subcutaneous Co-formulation JSKN033 was Approved (Alphamab Press Release) - "Alphamab Oncology...announced that a phase I/II clinical trial (Study ID: JSKN033-102) of JSKN033, a high-concentration subcutaneous co-formulation consisting of anti-HER2 bispecific antibody-drug conjugate (ADC) and PD-L1 immune checkpoint inhibitor, has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA)....JSKN033-102 is an open-label, multicenter, Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and anti-tumor activity of JSKN033 in patients with advanced metastatic malignant tumors, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D)."

New P1/2 trial • Solid Tumor

A Phase I/II Clinical Study of Anti-HER2 Bispecific ADC Subcutaneous Co-formulation JSKN033 was Included in the Pilot Program for Optimizing the Review and Approval of Clinical Trials for Innovative Drugs (Alphamab Press Release) - "Alphamab Oncology....announced that a clinical trial (Study ID: JSKN033-102) of JSKN033...meets the requirements of the 'Pilot Program for Optimizing the Review and Approval of Clinical Trials for Innovative Drugs', and has been included in the pilot project by the Shanghai Municipal Drug Administration with the consent of the Center for Drug Evaluation (CDE). The IND application will be submitted to CDE accordingly and is expected to undergo accelerated review and approval process, while expediting the initiation of the phase I/II clinical trial for advanced malignant tumors."

New P1/2 trial • Oncology

Late-Breaking Abstract! Alphamab Oncology Presented the Latest Clinical Data of Anti-HER2 bispecific ADC Subcutaneous Co-formulation JSKN033 at SITC 2024 (PRNewswire) - P1/2 | N=30 | NCT06226766 | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | "As of October 14, 2024, 11 patients were enrolled in the dose escalation phase and had received JSKN033 monotherapy across five dose levels (QW), among which 1 patient at the dose of 1.1mg/kg, 1 patient at the dose of 2.3mg/kg, 3 patients at the dose of 4.5mg/kg, 3 patients at the dose of 5.6mg/kg, and 3 patients at the dose of 6.7mg/kg. Safety: The most common Treatment-Related Adverse Events (TRAEs) were injection site reactions, all of which were grade 1 and usually resolved within 2 weeks without any treatment or with antihistamines. No dose-limited toxicity (DLT) was observed. Efficacy: Among the ten efficacy evaluable patients, three patients showed partial response (PR), while five patients demonstrated stable disease (SD), resulting in an 80% disease control rate (DCR)."

Late-breaking abstract • P1/2 data • Solid Tumor

Alphamab Oncology's JSKN033 clinical trial yields significant preliminary results [Google translation] (Eastmoney.com) - P1/2 | N=30 | NCT06226766 | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | "This study is a Phase I/II clinical trial, which mainly evaluates the safety, tolerability and preliminary efficacy of JSKN033 in patients with advanced HER2-expressing solid tumors or HER2-mutated non-small cell lung cancer. As of October 14, 2024, a total of 11 patients were enrolled and treated with different doses. The most common treatment-related adverse events were injection site reactions, all of which were grade 1 and usually resolved within two weeks....In terms of efficacy, among the 10 evaluable patients, 3 patients had partial remission (PR), 5 patients had stable disease (SD), and the disease control rate (DCR) reached 80%. JSKN033 showed anti-tumor activity at a dose of 4.5 mg/kg, and 7 patients are still receiving treatment."

P1/2 data • Lung Cancer • Oncology • Solid Tumor • HER-2

Alphamab Oncology to Present Chinese Clinical Data of JSKN003 for the Treatment of HER2-expressing Solid Tumors for the First Time at the 2024 ASCO Annual Meeting (PRNewswire-Asia) - "Alphamab Oncology...announced that data from the clinical study conducted in China (JSKN003-102) of anti-HER2 bispecific antibody-drug conjugate (ADC) JSKN003 for the treatment of HER2-expressing advanced solid tumors, will be presented for the first time at the 2024 Annual Meeting of American Society of Clinical Oncology....JSKN003-102 (NCT05744427) is a phase I (dose escalation and expansion) and phase II (cohort expansion) clinical study in Chinese patients with advanced solid tumors. Patients with histologically documented HER2-expressing (IHC≥1+) or patients with HER2-mutant cancers who failed prior systemic therapies were recruited and received JSKN003 monotherapy in phase I study."

P1 data • Solid Tumor

Alphamab Oncology Reports Full Year 2023 Financial Results and Business Highlights (PRNewswire-Asia) - "JSKN033:...The phase I dose escalation stage of the clinical trial of JSKN033 conducted in Australia is expected to be completed in 2024."

Trial status • Solid Tumor

JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastrointestinal Cancer • Oncology • Solid Tumor

Alphamab Oncology Announces the First Patient Dosed in Australia in the Clinical Study of Subcutaneous Formulation JSKN033 (PRNewswire-Asia) - "Alphamab Oncology...announced that the first patient has been dosed in Australia in the clinical study (JSKN033-101) of JSKN033, a subcutaneous formulation with HER2 bispecific antibody-conjugated drug and PD-L1 monoclonal antibody, for the treatment of HER2-expressing, advanced or metastatic solid tumors....JSKN033-101 is an open-label, muti-center, phase I/II clinical study. The study consists of dose escalation and dose expansion phases: the Phase I dose escalation stage aims to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JSKN033 in patients with advanced or metastatic HER2-expressing solid tumors..."

Trial status • Solid Tumor

JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Metastases • New P1/2 trial • Gastrointestinal Cancer • Oncology • Solid Tumor