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NCT07083323
A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors
Phase 1, PHASE2 trial testing HY05350 for injection in Advanced Solid Tumor in 262 participants. Currently enrolling.
31 March 2028
Quick facts
| Lead sponsor | Sichuan Huiyu Pharmaceutical Co., Ltd |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 262 |
| Start date | 22 July 2025 |
| Primary completion | 31 March 2028 |
| Estimated completion | 31 March 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- HY05350 for injection — full drug profile →
- HY05350 for injection — full drug profile →
Conditions studied
- Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
Sponsor
Sichuan Huiyu Pharmaceutical Co., Ltd — full company profile →
Who can join
Adults 18 to 75, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary clinical efficacy of HY05350 for injection in patients with MSLN-positive advanced solid tumors.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Decoding the role of mesothelin in tumor dynamics and targeted treatment innovations.
Silvestri R, Colucci E, Piccardi M, Landi S, et al · · 2025 · cited 2× · PMID 41335396 · DOI 10.1186/s43556-025-00379-z
Verify or expand the search:
- PubMed search for NCT07083323
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Solid Tumor
Currently open trials in the same condition.
- NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
- NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
- NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
- NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting
Other Sichuan Huiyu Pharmaceutical Co., Ltd trials
Trials by the same sponsor.
- NCT06977490 — Human Bioequivalence Study of Amphotericin B Liposome for Injection · NA · completed
- NCT06895993 — Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants · Phase 1 · completed
- NCT06765590 — Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer · NA · recruiting
- NCT06756490 — A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation · Phase 1 · recruiting
- NCT06712680 — A Phase I/II Study of HYP-6589 Monotherapy in Treating Advanced Solid Tumors and in Combination With Tyrosine Kinase Inh · 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 NCT07083323 (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 Sichuan Huiyu Pharmaceutical Co., Ltd
- Last refreshed: 25 November 2025
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/NCT07083323.
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