Clinical trial · Interventional
Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33
A Multi-center, Open-label, Single Arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.
NCT03544905CI-TRIAL-00088758completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a Multi-center, Open-label, single arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety , Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CYH33 for tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation study of CYH33
- description
- To determine the maximum tolerated dose (MTD) of CYH33
- interventionNames
- Drug: CYH33 for tablet
Primary outcomes (1)
- measure
- MTD(Max tolerance does)
- timeFrame
- 35 days
- description
- To evaluate the MTD in patients with advanced solid tumor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * main inclusion: 1. Evidence of a personally signed informed consent document; 2. Male and/or female subjects above the ages of 18 years; 3. Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a; 4. Subject may provide Tumor tissue section(at least 8 pieces) if they agree; 5. ECOG performance score 0-1; 6. Life expectancy ≥ 12 weeks; 7. At least 1 measurable target lesion on the baseline scan as per RECIST 1.1 Exclusion Criteria: * main criteria: 1. prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment; 2. Prior or concomitant other malignant tumor;
References
Publications (0)
Data not yet available
No reference posted for this study.