Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33

• Status: Unknown status
• Trial end date: 2021-08-20
• Target enrollment: 0
• Participant gender: All

Summary

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, and to Evaluate the Safety and Preliminary Efficacy in Advanced esophagus canver and Squamous cell carcinoma of the esophageal junction patients

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haihe Biopharma Co., Ltd.; ShangHai HaiHe Pharmaceutical

Criteria

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;