JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors

Starting soon · Phase 1

Conditions studied: Advanced Solid Tumor Malignancies

In brief

This is a Phase I, open-label, multicenter, first-in-human study to evaluate the safety, tolerability, PK/pharmacodynamic (PD) characteristics, and anti-tumor activity of JSKN016HC in subjects with advanced malignant solid tumors.

Key facts

Study ID

NCT07475559

Run by

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

People needed

42

Starts

2026-03-01

Expected to finish

2028-07-01

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are able to understand the informed consent form (ICF), voluntarily participate, and sign the ICF;
• Patients who are ≥18 years of age on the day of signing the informed consent form, male or female;
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1;
• Life expectancy ≥ 3 months;
• At least one non-cranial measurable lesion at baseline according to RECIST 1.1 criteria. Target lesions must not have received prior local therapy (e.g., radiotherapy), or there must be evidence of disease progression in the lesion after local therapy;
• Patients with histologically and/or cytologically confirmed advanced unresectable or metastatic epithelial-derived malignant tumors who have failed prior standard of care (disease progression, intolerance, or inaccessibility of standard of case);
• Adequate organ function (results from within 7 days before the first dose are required for the following laboratory tests; echocardiogram results from within 28 days before the first dose are acceptable):
• Bone marrow function (no whole blood or blood component transfusions within 14 days before the first dose; no use of haematopoietic growth factors within 7 days before the first dose): Absolute neutrophil count ≥1.5×109/L; haemoglobin ≥90 g/L; platelet count ≥100×109/L;
• Liver function (based on the normal values of each clinical study site): Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3×ULN (≤ 5×ULN for subjects with metastases to liver); albumin ≥ 28 g/L;
• Renal function: Blood creatinine ≤ 1.5 ×ULN, or creatinine clearance (Ccr) ≥ 60 mL/min as calculated by the Cockcroft-Gault formula; urine protein ≤ 1+ or 24-hour (h) quantitative urine protein < 1.0 g;
• Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
• Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% (by echocardiogram);
• Female patients of childbearing potential or male patients with partners of childbearing potential must agree to use highly effective contraception from the time of signing the ICF until 24 weeks after the last dose. Female patients of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose;
• Patients who are able and willing to comply with the visits, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.

You may not qualify if…

• Presence of metastasis to brainstem, metastasis to meninges, metastasis to spinal cord or compression, or a history of carcinomatous meningitis; presence of active brain metastasis. Note: a. For patients with brain metastasis previously treated with local therapy (e.g., surgery, radiotherapy): patients who are clinically stable for at least 4 weeks before the first dose (imaging examination shows stable lesions, no new neurological symptoms, no evidence of new or enlarging pre-existing brain metastasis), and have not required corticosteroids or anticonvulsants for at least 2 weeks are eligible for enrollment; b. For patients with brain metastasis not previously treated with local therapy: patients with no neurological symptoms related to brain metastasis, not requiring corticosteroid treatment, no significant oedema around brain metastasis, and with all brain metastases < 1.5 cm are eligible for enrollment;
• Imaging during the screening period shows the tumor invades or compresses the surrounding vital organs (e.g., heart and pericardium, trachea, oesophagus, superior vena cava, etc.) or risk of developing oesophageal-tracheal fistula or oesophageal-pleural fistula;
• Insufficient washout period for prior therapies before the first dose:
• Receipt of any investigational drug within 28 days before dosing;
• Receipt of other anti-tumor therapy within 28 days before dosing or within 5 half-lives of a prior anti-tumor drug (whichever is shorter, but at least 14 days is required);
• Receipt of Chinese herbal medicines or proprietary Chinese medicines with a clear anti-tumor indication within 14 days before dosing;
• Receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 14 days before the first dose;
• Requirement for continuous treatment with glucocorticoids (> 10 mg/day prednisone, or equivalent dose of other glucocorticoids) or immunosuppressants for 7 days within 14 days before the first dose; excluding inhaled or topical steroids, or physiological replacement doses of steroids for adrenal insufficiency; short-term (≤7 days) use of glucocorticoids for prophylaxis (e.g., for contrast media allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity due to allergen exposure) is permitted;
• Receipt of local palliative therapy within 14 days before dosing;
• Major surgery within 28 days before dosing (e.g., major abdominal or thoracic surgery; minor procedures such as diagnostic aspiration, infusion device implantation, or biliary stent placement are not included), or anticipation of requiring major surgery during the study;
• Receipt of a live vaccine within 30 days before the first dose, or planned receipt of a live vaccine during the study;
• Prior treatment with an ADC containing a topoisomerase I inhibitor (e.g., DS-8201, HER3-DXd, DS-1062, etc);
• Concurrent other malignant tumor within 5 years before dosing, excluding cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, and in situ prostate/cervical/breast cancer/ papillary thyroid carcinoma, etc;
• Presence or history of the following lung disorders that cause severe impairment of respiratory function:
• Active or severe structural lung disorder: including pulmonary embolism diagnosed within 6 months before the first dose, uncontrolled severe asthma (e.g., requiring continuous systemic steroid therapy or frequent acute exacerbations), severe chronic obstructive pulmonary disease, or severe restrictive pulmonary disease (e.g., severe pulmonary fibrosis, deformity thorax), etc.;
• Systemic diseases with pulmonary involvement: autoimmune diseases, connective tissue diseases, or inflammatory diseases (e.g., rheumatoid arthritis, sicca syndrome, sarcoidosis, etc.) causing significant impairment of respiratory function;
• Pulmonary resection: prior pneumonectomy;
• Current interstitial lung disease (ILD) or non-infectious pneumonia (e.g., idiopathic pulmonary fibrosis, radiation pneumonitis, etc.) requiring systemic glucocorticoid or other immunosuppressant therapy;
• Clinically significant gastrointestinal abnormalities, including but not limited to:
• Intestinal obstruction or signs and symptoms of intestinal obstruction within 6 months before the first dose, but screening is permissible if surgery has been performed and the obstruction is completely resolved (patients who have previously received an intestinal stent that has not been removed by the screening period are not allowed to enroll);
• History of gastrointestinal perforation, intestinal fistula, intra-abdominal abscess, and non-gastrointestinal fistula (e.g., oesophageal-tracheal fistula) within 6 months before the first dose;
• Gastrointestinal haemorrhage of ≥ Grade 3 (CTCAE v5.0) within 6 months before the first dose, or gastrointestinal haemorrhage within 1 month (including melaena, haematochezia, etc.; patients confirmed to have haemorrhoidal haemorrhage or only presenting with faecal occult blood positive are eligible for enrollment);
• Active autoimmune disease requiring systemic treatment within the past two years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants). Note: Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment;
• Presence of serous cavity effusion (e.g., pleural effusion, pericardial effusion, ascites) that is clinically symptomatic or requires repeated drainage(>1 time/week), or has required drainage within 14 days before the first dose;
• Presence of any of the following cardiovascular or cerebrovascular disorders or risk factors:

Where it is running

• Scientia Clinical Research Ltd — Sydney, New South Wales, Australia

Full record on ClinicalTrials.gov

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