Last reviewed · How we verify
NCT05609019
Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SYHX2005 in Patients With Advanced Solid Tumors
Phase 1 trial testing SYHX2005 in Advanced Solid Tumors in 139 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | CSPC Ouyi Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 139 |
| Start date | 1 December 2022 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 December 2025 |
Drugs / interventions tested
- SYHX2005 — full drug profile →
Conditions studied
- Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
Sponsor
CSPC Ouyi Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 70, 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.
-
Maximum Tolerated Dose(MTD)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Maximum tolerated dose -
Overall Response Rate (ORR) in stage 2
Time frame: up to approximately 2 years
Overall Response Rate
Sponsor's own description
This is a first-in-human study with the SYHX2005 tablet primarily designed to evaluate the safety and tolerability of SYHX2005 at increasing doses in patients with advanced solid tumors and for whom no standard of care exists. The study will be conducted in two parts: Stage1 dose-escalation and Stage2 dose-expansion. In Stage1, patient enrolment will be proceeded according to a "Accelerated Titration + BOIN" design in order to identify the maximum-tolerated dose (MTD) or recommended dose. In Stage2, preliminary efficacy response will be assessed in patients with advanced solid tumors in use of the recommended dose.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05609019
- 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 CSPC Ouyi Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07519109 — Study Evaluating the Safety, Efficacy and Pharmacokinetics of SYH9089 Injection in Patients Undergoing Abdominal Surgery · Phase 1 · not yet recruiting
- NCT07026968 — A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets · Phase 3 · active not recruiting
- NCT06943950 — A Phase III Study of SYHX1901 Tablets in the Treatment of Moderate to Severe Plaque Psoriasis · Phase 3 · not yet recruiting
- NCT06562894 — Study to Evaluate Safety and Efficacy of SYHX1901 Tablets in Severe Alopecia Areata Patients · Phase 2 · not yet recruiting
- NCT06958692 — A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder · Phase 3 · recruiting
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 NCT05609019 (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 CSPC Ouyi Pharmaceutical Co., Ltd.
- Last refreshed: 4 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/NCT05609019.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing