JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors

NCT07475559 | Not Yet Recruiting Phase 1

• 1 other identifier: JSKN016HC-101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (3)

• Incidence of dose-limiting toxicities (DLTs) in each dose group of JSKN016HC

  DLTs are defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

  Baseline up to 28 days after the first dose

• Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc., during treatment with JSKN016HC;

  Clinically significant changes in physical examination findings, vital sign measurements, standard clinical laboratory parameters, 12-lead electrocardiogram (ECG) parameters, ECHO cardiography or multiple-gated acquisition (MUGA) scan findings will be recorded as AEs.

  Postdose of last participant up to 2 year

• MTD and/or RP2D of JSKN016HC.

  To determine MTD/RP2D of JSKN016HC.

  Postdose of last participant up to 2 year

Secondary Outcomes (9)

• Objective response rate (ORR)

  From 6 weeks postdose of last participant up to 2 years

• Duration Of Response (DoR) of JSKN016HC

  Postdose of last participant up to 2 years

• Progression-Free Survival (PFS) Following Treatment With JSKN016HC in Participants

  Postdose of last participant up to 2 years

• 6-month and 12-month overall survival (OS) rates

  Postdose of last participant up to 2 years

• Maximum concentration (Cmax) of JSKN016HC

  Postdose of last participant up to 2 year

Study Arms (1)

Dose Escalation

EXPERIMENTAL

This study will use i3+3 design for dose escalation, with a total of 4-7 dose cohorts designed. The starting dose is 4 mg/kg, Q2W. The dose cohorts and observation periods are defined in the Dose Escalation Table. During the study, necessary adjustments to the escalation dose and dosing interval may be made based on the obtained safety, PK, and other results.

Drug: JSKN016HC

Interventions

JSKN016HC DRUG

JSKN016HC is a subcutaneously injectable formulation of a bispecific ADC targeting HER3 and TROP2 (the main active ingredient is JSKN016).

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.;

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

Scientia Clinical Research Ltd

Sydney, New South Wales, 2031, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)