Last reviewed · How we verify
NCT07533123
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
Phase 3 trial testing JSKN016 Injection in Triple Negative Breast Cancer in 364 participants. Currently enrolling.
17 March 2029
Quick facts
| Lead sponsor | Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 364 |
| Start date | 17 March 2026 |
| Primary completion | 17 March 2029 |
| Estimated completion | 17 March 2030 |
| Sites | 1 location across China |
Drugs / interventions tested
- JSKN016 Injection — full drug profile →
- Eribulin Mcsilate Injection
- Vinorelbine Tartrate Injection
- Capecitabine Tablets — full drug profile →
- Gemcitabine Hydrochloride for Injection — full drug profile →
- Sacituzumab Govitecan for Injection
Conditions studied
- Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd — full company profile →
Who can join
Adults 18 to 75, any sex, with Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary Endpoint of this Study: To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee \[BIRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST v1.1\]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC). To compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07533123
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Triple Negative Breast Cancer
Currently open trials in the same condition.
- NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
- NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
- NCT07281976 — A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer · Phase 1, PHASE2 · recruiting
- NCT06225505 — Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE) · NA · recruiting
- NCT07318805 — A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
Other Jiangsu Alphamab Biopharmaceuticals Co., Ltd trials
Trials by the same sponsor.
- NCT07391644 — A Study of JSKN027 in Patients With Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07475559 — JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors · Phase 1 · not yet recruiting
- NCT07283198 — A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients Wit · Phase 2 · not yet recruiting
- NCT07292402 — JSKN022 in Subjects With Advanced Malignant Solid Tumors · Phase 1 · recruiting
- NCT06942234 — Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07533123 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07533123.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing