JSKN016 TROP2/HER3 Bispecific ADC
JSKN016-101 (NCT06592417) is a Phase I study in China testing JSKN016, a first-in-class antibody-drug conjugate that targets both TROP2 and HER3, in adults with advanced or metastatic solid tumors. It studies the right dose, safety, and early anti-tumor activity of the drug given on its own. CancerFax helps patients and families understand whether this trial may be relevant and coordinate review with the trial centers.
About This Clinical Trial
Many people with advanced or metastatic solid tumors reach a point where standard chemotherapy, targeted therapy, or immunotherapy stops working or is no longer tolerated. This is common in heavily pre-treated breast cancer, lung cancer, and several other epithelial cancers, where remaining options can be limited and the disease may keep progressing. Trials of newer drug classes are one way these patients look for additional possibilities, always under specialist supervision.
JSKN016-101 (NCT06592417) is a first-in-human, open-label, multicenter Phase I study being conducted in China by Alphamab Oncology. It is testing JSKN016, a first-in-class antibody-drug conjugate (ADC) that targets two proteins at once, TROP2 and HER3, given as a single agent (monotherapy). The study has a dose-escalation part, which works out a safe and effective dose range, and a dose-expansion part, which studies that dose in specific tumor types.
TROP2 and HER3 are both frequently over-expressed on common solid tumors, including many breast and lung cancers, and higher levels are often linked with poorer outcomes. By binding either target, JSKN016 is designed to deliver a topoisomerase I inhibitor payload directly into tumor cells. Its homogeneous drug-to-antibody ratio of 4, produced through site-specific glycan conjugation, is intended to keep the drug stable and reduce off-target exposure. Early Phase I data reported encouraging activity and a manageable safety profile in heavily pre-treated patients, and HER2-negative breast cancer results from this study were presented at ASCO 2026.
Important distinction: NCT06592417 refers to the intravenous (IV) JSKN016 Phase I study (JSKN016-101). A separate subcutaneous formulation, JSKN016SC (study code JSKN016SC-102), is a newer and distinct program whose IND was accepted by China's NMPA/CDE in April 2026. Promotional posts sometimes mix the two. CancerFax confirms which specific study a patient is being matched to before any coordination.
The study is evaluating the safe dose, tolerability, pharmacokinetics, and early anti-tumor activity of JSKN016 monotherapy in advanced solid tumors, and identifying a recommended dose for later studies.
Trial at a Glance
A quick summary of the key facts about this trial. This is a snapshot only, not a confirmation that any individual patient is eligible.
Final eligibility is determined only by the trial investigators after reviewing complete medical records.
Treatment Being Studied
JSKN016 is an antibody-drug conjugate, or ADC. Think of it as a targeting antibody linked to a cancer-killing drug. The antibody part recognises tumor cells, and the linked drug is released to damage them, ideally with less effect on healthy tissue.
What makes JSKN016 unusual is that it targets two proteins at the same time, TROP2 and HER3, rather than one. Both are commonly found on solid tumors such as breast and lung cancers. In this Phase I study, JSKN016 is given on its own (monotherapy) by intravenous infusion.
How the therapy works (in simple terms)
JSKN016 attaches to TROP2 and/or HER3 on the surface of tumor cells. Once attached, the cell pulls the drug inside, where a topoisomerase I inhibitor payload is released to damage the cancer cell's DNA and trigger cell death. Some of the payload can also affect nearby tumor cells (a 'bystander' effect). The drug is built with a fixed drug-to-antibody ratio of 4 and site-specific conjugation, which is designed to keep it stable in the bloodstream and limit off-target exposure.
Review of diagnosis, imaging, prior treatments, organ function, and any required biomarker testing to confirm the patient fits the protocol.
In dose-escalation, patients are assigned to a dose level being tested. In dose-expansion, patients receive the dose selected from earlier cohorts.
JSKN016 is given as an IV infusion in cycles defined by the protocol, on a repeating schedule.
Close monitoring of blood counts, organ function, lung symptoms, and side effects between and during cycles.
Scans at set intervals to measure how the tumor is responding and to guide whether treatment continues.
Continued follow-up for safety and outcomes after treatment, as defined by the study.
JSKN016 is not an approved treatment. It is being studied in a Phase I trial, and its benefits and full safety profile are still being established.
Who This Trial May Be For
This trial may be relevant for certain adults with advanced solid tumors that have progressed after standard treatment. The points below describe the general profile only. Actual eligibility is decided by the trial team after reviewing complete records.
Adults with histologically confirmed advanced or metastatic solid tumors, such as heavily pre-treated breast cancer (including HER2-negative and triple-negative) and other epithelial cancers.
Disease that has progressed after, or could not tolerate, standard therapy. Promotional materials have also referenced EGFR-mutant NSCLC (2nd line and beyond) and other tumors such as kidney, thymic, liver, and pancreatic cancer; CancerFax verifies which cohorts are open before matching.
TROP2 and/or HER3 expression may be relevant for certain expansion cohorts. Existing IHC results help, and additional testing may be requested by the trial center.
Patients well enough for active treatment, typically with good day-to-day functioning and acceptable organ and bone marrow function.
Complete records must be reviewed by the trial investigators. Decisions are not made from a website listing or a summary alone.
The trial runs at multiple sites in China. International patients should be prepared for travel, translated records, visas, and a stay near the treating center.
Eligibility Criteria
The criteria below are a simplified, illustrative guide based on the trial type and public information. Meeting some of these points does not mean a patient is eligible. The full protocol has its own detailed inclusion and exclusion list, and only the trial center can confirm participation.
check_circleInclusion Criteria — May Be Eligible
- ✓Adults aged 18 years or older
- ✓Histologically or cytologically confirmed advanced or metastatic solid tumor
- ✓Disease progression after, or intolerance to, available standard therapy
- ✓Measurable or evaluable disease per protocol criteria
- ✓Adequate hematologic, hepatic, renal, cardiac, and pulmonary function
- ✓Acceptable performance status (e.g. ECOG 0–1) per protocol
- ✓TROP2 and/or HER3 status as required for specific expansion cohorts
- ✓Signed informed consent
cancelExclusion Criteria — May Not Be Eligible
- ×Active or prior interstitial lung disease / pneumonitis, or significant lung disease (typical exclusion for this ADC class)
- ×Active, uncontrolled infection
- ×Severe or unstable organ dysfunction
- ×Active, untreated central nervous system metastases
- ×Significant uncontrolled cardiac disease
- ×Pregnancy or breastfeeding
- ×Other conditions the investigator considers unsafe for trial participation
Criteria here are illustrative. The trial protocol has its own detailed list. CancerFax can help organize records for review, but only the trial center can confirm participation.
Medical Records and Tests Needed for Review
Good, complete records make review faster and more accurate. CancerFax helps families gather and organize these documents before sharing them with a trial center.
How the Trial Process May Work
Joining an early-phase ADC trial usually involves several steps before any treatment begins. The overview below shows the typical path.
CancerFax organizes the medical records and shares them with the relevant trial center for a first look.
The trial team reviews whether the patient may broadly fit the open cohorts and what additional information is needed.
Confirmatory tests at the trial center, which may include imaging, blood work, and biomarker testing.
The patient receives a full explanation of the study, risks, and rights, and signs consent before any trial treatment.
JSKN016 is given by intravenous infusion in cycles, with safety monitoring throughout.
Regular response scans and safety checks, with ongoing follow-up as defined by the protocol.
Potential Benefits
Clinical trials can offer access to therapies that are not yet widely available, along with close specialist monitoring. They are not a guaranteed treatment, and the points below should be weighed honestly with the treating team.
JSKN016 is a novel TROP2/HER3 bispecific ADC not available outside of clinical studies.
Patients are managed at experienced oncology centers in China that run early-phase trials.
Trial protocols usually involve more frequent labs, scans, and safety checks than routine care.
TROP2 and HER3 testing may help match patients to the most relevant cohort.
Participation helps build the evidence base for a new class of dual-targeted ADCs.
A structured protocol sets out dosing, monitoring, and follow-up steps clearly.
This is an early-phase study. It may or may not directly benefit any individual patient, and realistic expectations are essential.
Risks and Side Effects
Every trial carries risks specific to the therapy being studied. JSKN016 is an antibody-drug conjugate with a topoisomerase I inhibitor payload, so its risk profile is expected to reflect that drug class. The specific safety profile of JSKN016 is still being characterized.
ADCs with deruxtecan-type payloads can cause interstitial lung disease or pneumonitis, which can be serious. New cough, breathlessness, or fever must be reported promptly. Incidence specific to JSKN016 is still being studied.
Reduced neutrophils, red cells, or platelets are common with this drug class and can raise the risk of infection, fatigue, or bleeding. Regular blood tests are required.
Common with ADCs of this type and usually managed with supportive medication.
Fatigue, alopecia, and decreased appetite are frequently seen with this class of treatment.
Reactions can occur during or after an IV infusion and are monitored closely by the trial team.
Because JSKN016 is investigational, not all risks, including long-term effects, are yet known.
Travel and time burden, no guaranteed benefit, and the possibility of trial discontinuation should all be weighed carefully with the family and treating team.
Trial Location and Hospital Information
JSKN016-101 is running at multiple sites in China. Public materials list Professor Herui Yao of Sun Yat-sen Memorial Hospital, Sun Yat-sen University (Guangzhou) as principal investigator for the breast cancer cohort. Major Chinese cancer centers are typical participating sites. Patients must be evaluated at a participating trial center, and the open sites for a given cohort should be confirmed before any travel.
International patients typically need translated medical records, a remote case review by the trial center, a valid visa, accommodation near the hospital, and on-the-ground coordination. CancerFax helps organize records, communicate with the centers, and support travel and translation logistics.
Costs, Trial Coverage, and Patient Expenses
Costs vary by trial, sponsor, site, and whether the patient is local or international. Some items may be covered by the study, while travel, accommodation, and supportive care are usually the patient's responsibility. Only the trial center can confirm coverage in writing.
CancerFax helps families understand the expected cost categories and what may be covered. Final confirmation must come from the trial center in writing.
Standard Treatment vs Clinical Trial
Standard treatment and trial participation each have trade-offs. The table below outlines the general differences to help patients and families discuss options with their oncologist.
How CancerFax Helps Patients Explore This Trial
CancerFax is a specialist cancer-access and patient-navigation platform. For complex options like early-phase ADC trials in China, we help families get organized, communicate clearly with trial centers, and understand each step, without overpromising.
We organize and structure diagnosis, pathology, biomarker, imaging, and treatment records for clear review.
We help check how the trial's criteria may apply and identify gaps in testing or documentation.
We communicate with the relevant trial centers in China and relay their questions and requirements.
We support visa guidance, travel planning, accommodation near the hospital, and admission coordination.
We help families understand this trial in context, including approved options and other relevant studies.
We stay alongside the family from first review through follow-up, with translation support throughout.
CancerFax does not guarantee trial enrollment, treatment response, or outcome. Our role is to help patients access accurate information and appropriate pathways.
Questions to Ask Before Considering This Trial
These questions can help patients and families have a clearer, more informed discussion with their oncologist and the trial team.
Frequently Asked Questions
Want to Know Whether This Trial May Be Relevant?
Share the medical reports and CancerFax will help review the case, organize documents, and coordinate with the relevant trial centers in China.
The information on this page is for educational and patient-navigation purposes only. It does not replace medical advice, diagnosis, or treatment from a qualified physician. Clinical trial eligibility, enrollment, treatment decisions, and costs are determined only by the trial investigators, hospital, sponsor, and applicable regulations. CancerFax helps patients and families understand options and coordinate case review where appropriate, but does not guarantee trial acceptance, treatment response, or clinical outcome. All clinical decisions must be made in consultation with a qualified, licensed physician with access to the patient's complete medical information.
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© CancerFax · Specialist cancer access and patient-navigation platform. CancerFax is not a medical institution, hospital, or clinical trial sponsor. Trial details may change; always confirm current eligibility, status, and costs directly with the trial center.