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NCT04434326
The Absorption, Metabolism and Excretion of [14C]CM082 in Human
Phase 1 trial testing [14]CM082 suspension in Advanced Solid Tumor in 4 participants. Completed in 22 October 2021.
22 October 2021
Quick facts
| Lead sponsor | AnewPharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 5 July 2021 |
| Primary completion | 22 October 2021 |
| Estimated completion | 22 October 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- [14]CM082 suspension — full drug profile →
Conditions studied
- Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
Sponsor
AnewPharma — full company profile →
Who can join
Adults 18 to 50, male only, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of \[14C\] CM082 in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the completion date of plasma, urine and feces sampling on the 3rd day post-dose and onwards. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 4-6 subjects will be adjusted according to the pilot study
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04434326
- 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 AnewPharma trials
Trials by the same sponsor.
- NCT04328506 — Bioequivalency Study of CM082 Tablet in Healthy Volunteers · Phase 1 · completed
- NCT04126668 — A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers · Phase 1 · completed
- NCT04222842 — CM082 in Patients With Myopic Choroidal Neovascularization (CNV) · Phase 1 · suspended
- NCT03904719 — CM082 and JS001 in Patients With Advanced Small-cell Lung Cancer (SCLC) · Phase 2 · unknown
- NCT03710863 — Safety and Tolerability of Oral CM082 in Patients With wAMD · Phase 2 · unknown
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 NCT04434326 (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 AnewPharma
- Last refreshed: 14 November 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/NCT04434326.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing