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NCT06209385
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of YZJ-5053 Tablets in Participants With Advanced Solid Tumors
Phase 1 trial testing YZJ-5053 tablets in Solid Tumor in 157 participants. Currently enrolling.
1 October 2027
Quick facts
| Lead sponsor | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 157 |
| Start date | 11 August 2023 |
| Primary completion | 1 October 2027 |
| Estimated completion | 1 January 2028 |
| Sites | 4 locations across China |
Drugs / interventions tested
- YZJ-5053 tablets — full drug profile →
Conditions studied
- Solid Tumor — all drugs for Solid Tumor →
Sponsor
Shanghai Haiyan Pharmaceutical Technology Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with 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.
-
Determination of Maximum Tolerated Dose (MTD) of YZJ-5053
Time frame: 21days as a cycle
The MTD will be based on dose limiting toxicity (DLT) -
To identify a recommended Phase 2 dose (RP2D) of YZJ-5053
Time frame: 21days as a cycle
RP2D will be be based on MTD -
Number of participants with treatment-related adverse events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Time frame: 21days as a cycle
All events with a Grade 3 or above toxicity (defined by the NCI-CTCAE 5.0) will be tabulated by event and by relationship to YZJ-5053
Sponsor's own description
The goal of this study is to evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of YZJ-5053 Tablets in Participants with Advanced Solid Tumors
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06209385
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Solid Tumor
Currently open trials in the same condition.
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- NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
- NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting
Other Shanghai Haiyan Pharmaceutical Technology Co., Ltd. trials
Trials by the same sponsor.
- NCT06671444 — Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment · Phase 1 · active not recruiting
- NCT06671509 — Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment · Phase 1 · completed
- NCT06681493 — A Phase 1 Study of YZJ-4729 Tartrate Injection in Healthy Chinese Subjects · Phase 1 · completed
- NCT06680505 — Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder · Phase 2 · completed
- NCT06685341 — PK/PD Study of YZJ-1139 · 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 NCT06209385 (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 Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
- Last refreshed: 7 January 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/NCT06209385.
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