# JSKN016

Source: https://onco.cc/drugs/jskn016/  
OnCo record `jskn016` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

JSKN016 is an experimental drug that targets two proteins on cancer cells and carries chemotherapy. It has reached phase 3 testing; earlier response findings do not prove comparative benefit.

## Summary

JSKN016 targets TROP2 and HER3. SABCS 2025 abstract PS1-09-05 reports an uncontrolled phase I breast cohort at the September 5, 2025 cutoff: 82 enrolled patients, including 50 with TNBC and 32 with HR-positive/HER2-negative disease. Among 47 efficacy-evaluable TNBC patients, ORR was 57.4% by investigators and 63.8% by independent review. Median follow-up was 5.0 months. Grade 3 neutropenia occurred in 4.9% of the breast cohort; no interstitial lung disease was reported in that abstract. NCT07533123 separately registers phase 3 testing in previously treated TNBC. Its highest registered phase is not the evidence level of the phase I response estimate.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-10-06
- Tags: pipeline; ctgov-ingest
- Modality: ADC
- Mechanism: Bispecific anti-TROP2/HER3 antibody-drug conjugate with a cleavable linker and a TOP1 inhibitor payload.
- Payload: TOP1 inhibitor, DAR 4

## Sources

- Publisher abstract: https://doi.org/10.1158/1557-3265.sabcs25-ps1-09-05
- Publisher abstract: https://doi.org/10.1200/jco.2025.43.16_suppl.e13138
- ClinicalTrials.gov NCT06592417: https://clinicaltrials.gov/study/NCT06592417
- ClinicalTrials.gov NCT07533123: https://clinicaltrials.gov/study/NCT07533123

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Bispecific ADC](https://onco.cc/technologies/bispecific-adc/)
- targets: [HER3](https://onco.cc/targets/her3/), [TROP2](https://onco.cc/targets/trop2/)
- companies: [Alphamab Oncology](https://onco.cc/companies/alphamab/)
- trials: [A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care](https://onco.cc/trials/nct07533123/), [Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study](https://onco.cc/trials/nct06775483/), [Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer](https://onco.cc/trials/nct06942234/), [To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors](https://onco.cc/trials/nct06592417/)

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