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NCT05435768: PRaG 2X
PraG With RANKL Inhibitor for the Treatment of Advanced Multiple Metastatic Solid Tumors
trial testing Denosumab in Metastatic Solid Tumor in 51 participants. Status unknown.
15 August 2024
Quick facts
| Lead sponsor | Second Affiliated Hospital of Soochow University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 51 |
| Start date | 16 August 2022 |
| Primary completion | 15 August 2024 |
| Estimated completion | 15 August 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Denosumab (DENOSUMAB) — full drug profile →
Conditions studied
- Metastatic Solid Tumor — all drugs for Metastatic Solid Tumor →
Sponsor
Second Affiliated Hospital of Soochow University
Who can join
18 and older, any sex, with Metastatic Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The PraG treatment model has synergistic effects with RANKL inhibitor therapy, and the combination of the two treatments provides a survival benefit for patients with multiple bone metastatic solid tumors who have failed first-line systemic therapy. Phase I clinical trial is planned to determine the safety of PraG treatment mode combined with RANKL inhibitor desomumab and the optimal treatment sequence and mode. Further phase II clinical trial was conducted to confirm the efficacy of PraG treatment combined with desomumab. The mechanism of combination therapy was analyzed and biomolecular markers for potential efficacy prediction were screened by detection of lymphocyte subsets, cytokines and metabolomics in peripheral blood.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy and Safety of PRaG Therapy in Elderly Patients with Advanced Malignant Tumors: A Prospective, Multicenter Clinical Study Protocol (PRaG 9.0 Study).
Zhao X, Yang M, Zhang J, Kong Y, et al · · 2025 · PMID 41308040 · DOI 10.1177/15330338251400412 -
Denosumab combined with immunotherapy, radiotherapy, and granulocyte-macrophage colony-stimulating factor for the treatment of metastatic nasopharyngeal carcinoma: A case report.
Chen WW, Kong YH, Zhang LY. · · 2025 · PMID 39995562 · DOI 10.5306/wjco.v16.i2.95642
Verify or expand the search:
- PubMed search for NCT05435768
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Metastatic Solid Tumor
Currently open trials in the same condition.
- NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
- NCT07213817 — A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of · Phase 1, PHASE2 · recruiting
- NCT07156253 — Study of SYN818 With Olaparib for the Treatment of Locally Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
- NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
- NCT06666270 — Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
Other Second Affiliated Hospital of Soochow University trials
Trials by the same sponsor.
- NCT07327411 — Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors · Phase 2 · not yet recruiting
- NCT07241897 — DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes · Phase 3 · not yet recruiting
- NCT07267234 — PRaG-1 Plus PRaG Therapy in Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0) · Phase 2 · not yet recruiting
- NCT07095790 — Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke · Phase 4 · recruiting
- NCT07002502 — Immune Modulation With PRaG-1 Treatment · Phase 2 · not yet 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 NCT05435768 (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 Second Affiliated Hospital of Soochow University
- Last refreshed: 18 August 2022
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/NCT05435768.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing