Brief Summary
A Multicenter, Open-Label, Phase I Dosethe amount of medication taken Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the Combination of YH003, YH001 and Pembrolizumab in Subjects with Advancedat a late stage, far along Solid Tumors.
Intervention / Treatment
- Drug: YH003
- Drug: YH001
- Drug: Pembrolizumab
Inclusion Criteria
- 1. Subjects must have the ability to understand and willingness to sign a written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. document.
- 2. Subjects must have histologically advanced or cytologically confirmed solid tumor.
- 3. Subjects have progressed on after treatment with at least one standard therapy, or intolerant of the standard therapy, or no standard therapy accessible to the patients due to any reason
- 4. Subject must have at least 1 unidimensional measurable disease by RECIST 1.1(Eisenhauer et al., 2009).
- 5. Subjects must be age 18 years or older.
- 6. Subjects must have an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1.
- 7. Life expectancy ≥3 months based on investigator’s judgement.
- 8. Subjects must meet the following laboratory values at the screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening
- 9. Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test within 7 days of the first dose of study drugs.
- 10. Women of reproductive potential who are sexually active with a non-sterilized male must consistently use highly effective contraception/birth control between signing of the informed consent and 120 days after the last administration of the study drugs.