Advanced Solid Tumor MalignanciesPhase 1NCT07475559
JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors
A Phase 1 study testing JSKN016HC in people with Advanced Solid Tumor Malignancies, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor Malignancies
- What is being tested?
- JSKN016HC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Mar 2026to 1 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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:
- Myocardial infarction, unstable angina, acute or persistent myocardial ischaemia, Grade ≥3 cardiac failure (NYHA classification), symptomatic or poorly controlled severe arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, complete left or right bundle branch block, history of second- or third-degree heart block, etc.), cerebrovascular accident, transient ischaemic attack, or other severe cardiovascular or cerebrovascular disorders within 6 months before the first dose;
- Any arterial thromboembolic event or venous thromboembolic event of ≥ Grade 3 (CTCAE v5.0) within 6 months before the first dose;
- Presence of major vascular diseases that may be life-threatening or require surgery within 6 months, such as aortic aneurysm, aortic dissection, or severe internal carotid artery stenosis;
- Risk of QT interval prolongation or severe arrhythmia, including baseline QT interval corrected by Fridericia's formula (QTcF) > 470 ms, refractory hypokalaemia, long QT syndrome, etc.;
- Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
- Presence of moderate to severe pulmonary arterial hypertension;
- Uncontrolled infection, including but not limited to the following:
- Active HBV or HCV infection. HBsAg-positive patients are required to undergo HBV-DNA testing; if HBV-DNA is above the lower limit of detection of the local laboratory, they will be excluded. For HBsAg-positive patients, enrollment is permitted if HBV-DNA is below the lower limit of detection after receiving antiviral therapy, and anti-HBV therapy should be continued after subsequent treatment. HCV-Ab-positive patients are eligible for enrollment if HCV-RNA test is negative;
- Severe infection within 4 weeks before the first dose, including but not limited to comorbidities requiring hospitalisation, sepsis, or severe pneumonia; active infection requiring systemic anti-infective drug therapy within 2 weeks before the first dose;
- History of immunodeficiency, positive test for human immunodeficiency virus (HIV), or history of acquired immunodeficiency syndrome (AIDS);
- Known active tuberculosis;
- Active syphilis;
- Toxicity from prior anti-tumor therapy has not resolved to ≤ Grade 1 (CTCAE v5.0) or the level specified in the inclusion/exclusion criteria. Note: Patients with chronic, stable Grade 2 toxicity that the investigator considers related to prior anti-tumor therapy may be enrolled after discussion with the sponsor and medical monitor (defined as stable toxicity severity, CTCAE Grade ≤2, within 3 months before the first dose), such as: chemotherapy-induced neurotoxicity, alopecia, skin hyperpigmentation, fatigue, endocrine toxicity from prior immunotherapy (e.g., thyroid dysfunction, diabetes mellitus, adrenal insufficiency);
- History of prior allogeneic bone marrow or organ transplant;
- Known hypersensitivity to any component of the investigational product; history of severe allergic reactions to other antibody-based drugs;
- History of severe xerophthalmia, severe meibomian gland disease and/or blepharitis, keratopathy causing incurable or delayed healing of the subject's cornea, or maculopathy;
- Women who are pregnant and/or breastfeeding, or who plan to become pregnant during the study;
- Known history of psychiatric illness, drug abuse, alcoholism, etc., or other conditions that, in the investigator's opinion, would interfere with the safety or compliance of drug therapy in this study;
- Prior or current presence of any other disease, treatment, or abnormal laboratory test that might confound the study results, interfere with the subject's full participation in the study, or for which participation in the study might not be in the subject's best interest;
- Presence of local or systemic diseases caused by non-malignant tumor, or diseases or symptoms secondary to the tumor, which may lead to higher medical risk and/or uncertainty in survival assessment, such as tumor-related leukaemoid reaction (white blood cell count >20×109/L), cachexia, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Scientia Clinical Research Ltd
Sydney, New South Wales, 2031
Scientia Clinical Research Ltd, 0293825806, christina.teng@scientiaclinicalreseacher.com.au
Christina Teng, Scientia Clinical Research
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics, and Anti-tumor Activity of JSKN016HC in Subjects With Advanced Malignant Solid Tumors
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.
Read the detailed description
JSKN016HC is a subcutaneously injectable formulation of a bispecific ADC targeting HER3 and TROP2 (the main active ingredient is JSKN016).
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.
During dose escalation, the SMC will conduct continuous safety assessments. The safety data for each dose cohort must be reviewed and a decision must be made by the SMC before dosing of the next dose cohort can begin. For Dose Cohort 2 (5 mg/kg Q2W), Dose Cohort 4 (7 mg/kg Q2W), and Dose Cohort 6 (9 mg/kg Q2W), the SMC may decide whether to skip these dose cohorts based on a comprehensive consideration of prior safety, PK (if available), and other data.
- Conditions
- Advanced Solid Tumor Malignancies
- Being tested
- JSKN016HC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSKN016HCDrug
JSKN016HC is a subcutaneously injectable formulation of a bispecific ADC targeting HER3 and TROP2 (the main active ingredient is JSKN016).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: JSKN016HC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postdose of last participant up to 2 year
MTD and/or RP2D of JSKN016HC.
To determine MTD/RP2D of JSKN016HC.
Measured: Postdose of last participant up to 2 year
Secondary outcomes (9)
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.
Measured: From 6 weeks postdose of last participant up to 2 years
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.
Measured: Postdose of last participant up to 2 years
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
Measured: Postdose of last participant up to 2 years
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.
Measured: Postdose of last participant up to 2 years
Maximum concentration (Cmax) of JSKN016HC
JSKN016HC , total antibody (Tab) , payload of JSKN016HC
Measured: Postdose of last participant up to 2 year
Time at which Cmax is reached (Tmax)
JSKN016HC, total antibody (Tab) , payload of JSKN016HC
Measured: Postdose of last participant up to 2 year
Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)
JSKN016HC, total antibody (Tab) , payload of JSKN016HC
Measured: Postdose of last participant up to 2 year
Clinical Benefit Rate (CBR)
The proportion of participants in the study who achieve a confirmed CR, PR, or SD lasting at least 24 weeks, as assessed based on RECIST v1.1 criteria.
Measured: Postdose of last participant up to 2 years
Disease Control Rate (DCR)
The proportion of participants in the study who achieve a confirmed CR, PR, or SD as assessed based on RECIST v1.1 criteria
Measured: Postdose of last participant up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor MalignanciesStudies of the same condition, open and under way.
- More trials run by Jiangsu Alphamab Biopharmaceuticals Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475559
- Sponsor's protocol ID
- JSKN016HC-101
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics, and Anti-tumor Activity of JSKN016HC in Subjects With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07475559
- Acronym / sponsor ID
- JSKN016HC-101
- Conditions
- Advanced Solid Tumor Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
JSKN016HC is a subcutaneously injectable formulation of a bispecific ADC targeting HER3 and TROP2 (the main active ingredient is JSKN016).
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.
During dose escalation, the SMC will conduct continuous safety assessments. The safety data for each dose cohort must be reviewed and a decision must be made by the SMC before dosing of the next dose cohort can begin. For Dose Cohort 2 (5 mg/kg Q2W), Dose Cohort 4 (7 mg/kg Q2W), and Dose Cohort 6 (9 mg/kg Q2W), the SMC may decide whether to skip these dose cohorts based on a comprehensive consideration of prior safety, PK (if available), and other data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: JSKN016HCThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (45 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JSKN016HCJSKN016HC is a subcutaneously injectable formulation of a bispecific ADC targeting HER3 and TROP2 (the main active ingredient is JSKN016). | Drug | Dose Escalation |
Primary outcome
Incidence of dose-limiting toxicities (DLTs) in each dose group of JSKN016HC
Time frame: Baseline up to 28 days after the first dose
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;
Time frame: Postdose of last participant up to 2 year
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.
Time frame: Postdose of last participant up to 2 year
To determine MTD/RP2D of JSKN016HC.
9 secondary outcomes
Objective response rate (ORR)
Time frame: From 6 weeks postdose of last participant up to 2 years
Duration Of Response (DoR) of JSKN016HC
Time frame: Postdose of last participant up to 2 years
Progression-Free Survival (PFS) Following Treatment With JSKN016HC in Participants
Time frame: Postdose of last participant up to 2 years
6-month and 12-month overall survival (OS) rates
Time frame: Postdose of last participant up to 2 years
Maximum concentration (Cmax) of JSKN016HC
Time frame: Postdose of last participant up to 2 year
Time at which Cmax is reached (Tmax)
Time frame: Postdose of last participant up to 2 year
Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)
Time frame: Postdose of last participant up to 2 year
Clinical Benefit Rate (CBR)
Time frame: Postdose of last participant up to 2 years
Disease Control Rate (DCR)
Time frame: Postdose of last participant up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scientia Clinical Research Ltd
Sydney, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JSKN016HC in people with Advanced Solid Tumor Malignancies, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) in each dose group of JSKN016HC (time frame: Baseline up to 28 days after the first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.