Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
* main inclusion:
- Evidence of a personally signed informed consent document;
- Male and/or female subjects above the ages of 18 years;
- Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a;
- Subject may provide Tumor tissue section(at least 8 pieces) if they agree;
- ECOG performance score 0-1;
- Life expectancy ≥ 12 weeks;
- At least 1 measurable target lesion on the baseline scan as per RECIST 1.1
EXCLUSION CRITERIA
Exclusion Criteria:
* main criteria:
- prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment;
- Prior or concomitant other malignant tumor;
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Advanced Solid Tumors
Age
18+
Phase
PHASE1
Participants Needed
100
Est. Completion Date
Mar 31, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Haihe Biopharma Co., Ltd.
ClinicalTrials.gov NCT Identifier
NCT03544905
Study Number
CYH33-101
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