A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors
Trial Parameters
Brief Summary
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination with Pembrolizumab in Subjects with Locally Advanced/Metastatic Solid Tumors
Eligibility Criteria
Inclusion Criteria: 1. Male or female subjects age ≥ 18 years at the time of informed consent. 2. Subjects with histologically or cytologically diagnosed unresectable locally advanced, or metastatic solid tumors, mainly but not limited to CRC, TNBC, melanoma, OC, and who have progressed despite all standard therapy or are intolerant of all standard therapy, or for whom no effective standard therapy exists 3. Subjects must have at least 1 evaluable lesion as defined by response evaluation criteria in solid tumors (RECIST) v1.1. 4. ECOG PS of 0\~2. 5. Life expectancy ≥ 3 months. 6. Subjects have sufficient baseline organ function and laboratory data. 7. Woman of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment. 8. Female subjects of childbearing potential or male subjects with a partner of childbearing potential must agree to use effective contraception at the time of informed consent and continuing through the study until 6 months after t