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.
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;
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;
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);
Sequential
JSKN016HC
DrugJSKN016HC is a subcutaneously injectable formulation of a bispecific ADC targeting HER3 and TROP2 (the main active ingredient is JSKN016).
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.
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.
MTD and/or RP2D of JSKN016HC.
To determine MTD/RP2D of JSKN016HC.
Objective response rate (ORR)
Objective response rate (ORR) by investigators' review was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Duration Of Response (DoR) of JSKN016HC
DOR is defined as the time from assessment of complete response or partial response to disease progression or death in patients who achieve complete or partial response.
Progression-Free Survival (PFS) Following Treatment With JSKN016HC in Participants
PFS by investigator assessment is defined as the time from first dose of study drug to disease progression(as per RECIST v1.1) or death
6-month and 12-month overall survival (OS) rates
The 6-month and 12-month Overall Survival (OS) rate is typically estimated using the Kaplan-Meier method, which calculates the probability of survival at the 6-month time point while accounting for censored data.
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