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NCT06592417
To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors
Phase 1 trial testing JSKN016 injection in Advanced Malignant Solid Tumor in 140 participants. Currently enrolling.
17 May 2026
Quick facts
| Lead sponsor | Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 30 April 2024 |
| Primary completion | 17 May 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across China |
Drugs / interventions tested
- JSKN016 injection — full drug profile →
Conditions studied
- Advanced Malignant Solid Tumor — all drugs for Advanced Malignant Solid Tumor →
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd — full company profile →
Who can join
18 and older, any sex, with Advanced Malignant Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase I open, multi-center, first-in-human study evaluating JSKN016 in subjects with advanced metastatic solid tumors, divided into dose escalation and dose extension.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Technical, preclinical, and clinical developments of Fc-glycan-specific antibody-drug conjugates.
Yang Q, Liu Y. · · 2025 · cited 13× · PMID 39568595 · DOI 10.1039/d4md00637b -
Antibody-drug conjugates in breast cancer: mechanisms of resistance and future therapeutic perspectives.
Valle I, Grinda T, Antonuzzo L, Pistilli B. · · 2025 · cited 3× · PMID 41022825 · DOI 10.1038/s41523-025-00829-5 -
Overcoming resistance to antibody-drug conjugates: from mechanistic insights to cutting-edge strategies.
Zhou K, Liu X, Zhu H. · · 2025 · cited 2× · PMID 41185045 · DOI 10.1186/s13045-025-01752-9 -
Recent advances in bispecific antibody-drug conjugates for breast cancer therapy.
Ji X, Yang Y, Ma C, Huang W, et al · · 2026 · cited 1× · PMID 41579215 · DOI 10.1007/s00280-025-04863-9 -
Evolution of bispecific and multispecific antibodies in cancer therapy.
Fontana E, Grochot R, Kotecki N, Doger B, et al · · 2026 · PMID 42099877 · DOI 10.1016/j.lanepe.2026.101599 -
Prevalence of antibody drug conjugated-induced nausea and vomiting (ADCINV) in patients with cancer.
Chow R, Zhang D, Kannout S, Ma A, et al · · 2026 · PMID 42068413 · DOI 10.1007/s00520-026-10674-2
Verify or expand the search:
- PubMed search for NCT06592417
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Malignant Solid Tumor
Currently open trials in the same condition.
- NCT07293754 — An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07050641 — Phase I/II Study of SCTB39-1 in Advanced Solid Tumours · Phase 1, PHASE2 · recruiting
- NCT06718946 — Study on the Safety and Efficacy of Intravenous Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
- NCT05477849 — A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with S · Phase 1 · recruiting
- NCT04165590 — Plasmodium Immunotherapy for Advanced Malignant Solid Tumors · Phase 1, PHASE2 · recruiting
Other Jiangsu Alphamab Biopharmaceuticals Co., Ltd trials
Trials by the same sponsor.
- NCT07533123 — A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who H · Phase 3 · recruiting
- 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
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 NCT06592417 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 19 September 2024
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/NCT06592417.
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