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NCT03792958
Phase I Study of CM082 Tablets in the Treatment of Advanced Malignant Solid Tumors: Safety, Tolerance and Pharmacokinetics
Phase 1 trial testing CM082 in Advanced Malignant Solid Tumors in 19 participants. Status unknown.
1 June 2023
Quick facts
| Lead sponsor | AnewPharma |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 26 February 2019 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 June 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- CM082 — full drug profile →
Conditions studied
- Advanced Malignant Solid Tumors — all drugs for Advanced Malignant Solid Tumors →
Sponsor
AnewPharma — full company profile →
Who can join
18 and older, any sex, with Advanced Malignant 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.
-
Maximum tolerable dose (MTD) or dose to absorb saturation
Time frame: From the first dose to the 28th day of administration -
Dose-Limiting Toxicity
Time frame: From the first dose to the 28th day of administration
Characteristics of dose-limiting toxicity (DLT), evaluation criteria: National Cancer Institute (NCI) CTC classification (version 4.03) -
Pharmacokinetic parameters
Time frame: From the first dose to the 28th day of administration
Peak concentration -
Pharmacokinetic parameters
Time frame: From the first dose to the 28th day of administration
Area under the time curve of blood concentration from 0 h to the last time of blood collection -
Pharmacokinetic parameters
Time frame: From the first dose to the 28th day of administration
0 to Infinite Area under Blood Drug Concentration Curve -
Pharmacokinetic parameters
Time frame: From the first dose to the 28th day of administration
Peak time
Sponsor's own description
This is a Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Oral Dosing of CM082 tablets in Chinese Patients With Advanced Malignant Solid Tumors
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Tumour-associated macrophages: versatile players in the tumour microenvironment.
Ji ZZ, Chan MK, Chan AS, Leung KT, et al · · 2023 · cited 18× · PMID 37965573 · DOI 10.3389/fcell.2023.1261749
Verify or expand the search:
- PubMed search for NCT03792958
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CM082
Trials testing the same drug.
- NCT04222842 — CM082 in Patients With Myopic Choroidal Neovascularization (CNV) · Phase 1 · suspended
- NCT03710863 — Safety and Tolerability of Oral CM082 in Patients With wAMD · Phase 2 · unknown
Other recruiting trials for Advanced Malignant Solid Tumors
Currently open trials in the same condition.
- NCT07292402 — JSKN022 in Subjects With Advanced Malignant Solid Tumors · Phase 1 · recruiting
- NCT06717750 — A Study of CSCJC3456 in Patients With Advanced Malignant Tumors · Phase 1 · recruiting
- NCT06728189 — A Clinical Research About CD70-targeted CAR-NKT Cells Therapy in Subjects with Advanced Malignant Solid Tumors · Phase 1 · recruiting
- NCT06499350 — A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06571422 — Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors · Phase 1 · recruiting
Other AnewPharma trials
Trials by the same sponsor.
- NCT04434326 — The Absorption, Metabolism and Excretion of [14C]CM082 in Human · Phase 1 · completed
- 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
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 NCT03792958 (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 AnewPharma
- Last refreshed: 10 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/NCT03792958.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing