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NCT04093466
A Phase 1, Multicenter, Open-label, Dose Escalation/expansion Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of CX1003 (Kanitinib) in the Patients with Relapsed Advanced or Metastatic Solid Tumors
Phase 1 trial testing CX1003 in Advanced Solid Tumor in 126 participants. Currently enrolling.
1 October 2025
Quick facts
| Lead sponsor | Beijing Konruns Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 126 |
| Start date | 27 April 2020 |
| Primary completion | 1 October 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- CX1003 — full drug profile →
Conditions studied
- Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
Sponsor
Beijing Konruns Pharmaceutical Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Advanced 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 dose-limiting toxicities (DLTs) by NCI CTCAE 5.0: Dose Escalation Stage
Time frame: First 5 weeks after initial administration of CX1003
Occurrence of any of the following toxicities was considered DLT if judged by the Investigator to be possibly, probably, or definitely related to the administration of CX1003: * Any Grade 3 or higher non-hematologic toxicity (including persisting nausea, vomiting, diarrhea, and electrolyte imbalances despite optimal medical management); * Grade 4 neutropenia for \>5 consecutive days; * Grade 3 or -
Maximum tolerated dose (MTD): Dose Escalation Stage
Time frame: First 5 weeks after initial administration of CX1003
The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients.
Sponsor's own description
CX1003 is a novel multi-target tyrosine kinase inhibitor that is designed to primarily inhibit vascular endothelial growth factor receptor 2 (VEGFR2) and hepatocyte growth factor receptor (HGFR/MET). This study aimed to evaluate the safety, pharmacokinetics, and antitumor activity of CX1003 in patients with refractory advanced or metastatic solid tumors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04093466
- 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 Beijing Konruns Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT06564272 — A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma · Phase 2 · recruiting
- NCT06194734 — A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer · Phase 3 · recruiting
- NCT05265338 — A Food Effect Study of KC1036 in Healthy Subjects · NA · completed
- NCT05260385 — To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors · Phase 1, PHASE2 · recruiting
- NCT05460546 — The Effect of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease · Phase 2 · 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 NCT04093466 (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 Beijing Konruns Pharmaceutical Co., Ltd.
- Last refreshed: 15 October 2024
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/NCT04093466.
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