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NCT04577703
First-In-Human Phase I Trial of Ningetinib ( CT053PTSA ) in the Patients With Advanced Solid Tumors
Phase 1 trial testing CT053PTSA in Advanced Solid Tumors in 20 participants. Completed in 10 December 2015.
10 December 2015
Quick facts
| Lead sponsor | Sunshine Lake Pharma Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 8 February 2014 |
| Primary completion | 10 December 2015 |
| Estimated completion | 10 December 2015 |
| Sites | 1 location across China |
Drugs / interventions tested
- CT053PTSA — full drug profile →
Conditions studied
- Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
Sponsor
Sunshine Lake Pharma Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase I, single-arm, single-center, open-label, dose-escalation Study evaluating the safety and efficacy of CT053PTSA in patients with Advanced Solid Tumors
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Small molecule inhibitors targeting the cancers.
Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181 -
Targeting MERTK and AXL in <i>EGFR</i> Mutant Non-Small Cell Lung Cancer.
Yan D, Earp HS, DeRyckere D, Graham DK. · · 2021 · cited 27× · PMID 34830794 · DOI 10.3390/cancers13225639 -
Two-Front War on Cancer-Targeting TAM Receptors in Solid Tumour Therapy.
Mikolajczyk A, Mitula F, Popiel D, Kaminska B, et al · · 2022 · cited 13× · PMID 35626092 · DOI 10.3390/cancers14102488 -
Preclinical characterization and phase I clinical trial of CT053PTSA targets MET, AXL, and VEGFR2 in patients with advanced solid tumors.
Ma YX, Liu FR, Zhang Y, Chen Q, et al · · 2022 · cited 8× · PMID 36341335 · DOI 10.3389/fimmu.2022.1024755 -
Structure and functions of Mer, an innate immune checkpoint.
Ubil E, Zahid KR. · · 2023 · cited 5× · PMID 37936688 · DOI 10.3389/fimmu.2023.1244170
Verify or expand the search:
- PubMed search for NCT04577703
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CT053PTSA
Trials testing the same drug.
- NCT04992858 — Ningetinib in Advanced NSCLC Skipping Mutations With MET Exon 14 Skipping Mutations · Phase 2 · unknown
- NCT03876925 — A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic RCC · Phase 1, PHASE2 · terminated
- NCT03125876 — A Phase Ib Study of CT053PTSA in Relapsed / Refractory Acute Myeloid Leukemia (AML) · Phase 1 · terminated
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 Sunshine Lake Pharma Co., Ltd. trials
Trials by the same sponsor.
- NCT07341672 — A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itrac · Phase 1 · not yet recruiting
- NCT05048368 — Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function · Phase 1 · not yet recruiting
- NCT07376200 — Single-ascending Dose Study of HEC-151 Injection · Phase 1 · not yet recruiting
- NCT07082842 — Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF · Phase 3 · not yet recruiting
- NCT07211165 — Clinical Study on the Mass Balance of Clifutinib · 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 NCT04577703 (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 Sunshine Lake Pharma Co., Ltd.
- Last refreshed: 8 October 2020
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/NCT04577703.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing