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NCT01226030
Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors
Phase 1 trial testing M2ES 7.5mg in Advanced Solid Tumors in 24 participants. Status unknown.
1 April 2011
Quick facts
| Lead sponsor | Protgen Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 September 2009 |
| Primary completion | 1 April 2011 |
| Estimated completion | 1 June 2011 |
| Sites | 1 location across China |
Drugs / interventions tested
- M2ES 7.5mg — full drug profile →
- M2ES 15mg — full drug profile →
- M2ES 30mg — full drug profile →
- M2ES 60mg — full drug profile →
Conditions studied
- Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
Sponsor
Protgen Ltd — full company profile →
Who can join
Adults 18 to 65, any sex, with Advanced Solid Tumors. 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.
-
The maximum tolerate dosage
Time frame: 4 weeks
The maxium tolerate dosage
Sponsor's own description
This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01226030
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Solid Tumors
Currently open trials in the same condition.
- NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
- NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
- NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other Protgen Ltd trials
Trials by the same sponsor.
- NCT06553456 — Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites · Phase 2, PHASE3 · completed
- NCT05858853 — Phase II/III of Recombinant Human Serum Albumin · Phase 2, PHASE3 · completed
- NCT05249374 — Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects · Phase 1 · completed
- NCT05179265 — Recombinant Human Serum Albumin in Healthy Subjects · Phase 1 · completed
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 NCT01226030 (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 Protgen Ltd
- Last refreshed: 20 October 2010
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/NCT01226030.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing