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NCT05911984
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors
Phase 1 trial testing 9MW3811 Injection in Advanced Malignant Solid Tumor in 27 participants. Status unknown.
1 March 2024
Quick facts
| Lead sponsor | Mabwell (Shanghai) Bioscience Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 30 June 2023 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 March 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- 9MW3811 Injection — full drug profile →
Conditions studied
- Advanced Malignant Solid Tumor — all drugs for Advanced Malignant Solid Tumor →
Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Advanced Malignant Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of adverse events (AEs) as assessed by CTCAE v5.0
Time frame: up to 24 weeks
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. -
Incidence of dose-limiting toxicity (DLT) as assessed by CTCAE v5.0
Time frame: Cycle 1 Day 1 to Cycle 1 Day 21
A DLT is defined as any of the adverse drug reactions listed in the protocol that will be assessed during Cycle 1
Sponsor's own description
This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety, tolerability and preliminary efficacy of 9MW3811 in patients with advanced solid tumors.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cancer-associated fibroblasts as therapeutic targets for cancer: advances, challenges, and future prospects.
Cao Z, Quazi S, Arora S, Osellame LD, et al · · 2025 · cited 57× · PMID 39780187 · DOI 10.1186/s12929-024-01099-2 -
Interleukin-11: A pivotal player and potential therapeutic target in prostate cancer.
Zhong J, Duan X, Wei Z, Zhu W, et al · · 2026 · PMID 41969323 · DOI 10.1097/cu9.0000000000000323
Verify or expand the search:
- PubMed search for NCT05911984
- 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
- NCT06592417 — To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors · Phase 1 · recruiting
- NCT05477849 — A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with S · Phase 1 · recruiting
Other Mabwell (Shanghai) Bioscience Co., Ltd. trials
Trials by the same sponsor.
- NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07314723 — 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer · Phase 2 · recruiting
- NCT06926998 — 9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors · Phase 1, PHASE2 · not yet recruiting
- NCT06804590 — A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis · Phase 3 · recruiting
- NCT06692166 — A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Ca · Phase 3 · 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 NCT05911984 (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 Mabwell (Shanghai) Bioscience Co., Ltd.
- Last refreshed: 12 June 2023
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/NCT05911984.
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