Study on the Safety and Effectiveness of NC410 and Pembrolizumab for Advanced Solid Tumors

Inclusion Criteria

• Be 18 years or older.
• Have a confirmed diagnosis of advanced solid tumors that cannot be surgically removed or have spread, including colorectal, gastric, esophageal, ovarian, and head and neck cancers.
• For Phase 1b: Must have experienced disease progression after at least one standard treatment or have stopped treatment due to intolerance or refusal.
• For Phase 2: Must have tumors that did not respond to previous anti-PD1/L1 treatments or have not been treated with these immunotherapies before.
• Male participants must agree to use contraception and not donate sperm during the study and for 120 days after the last dose.
• Female participants must not be pregnant or breastfeeding and agree to use contraception if of childbearing potential.
• Have measurable disease as determined by medical imaging.
• Be able to provide a tumor tissue sample for analysis.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have a life expectancy of at least 12 weeks.
• Have adequate organ function as determined by specific medical tests.

Exclusion Criteria

• Women who are pregnant or breastfeeding.
• Have had severe allergic reactions to pembrolizumab, NC410, or similar drugs.
• Have received certain cancer treatments or vaccines within a specified time before the study.
• Have a history of organ transplant or certain immune system disorders.
• Have active infections or other serious medical conditions that could interfere with the study.
• Have known active HIV, Hepatitis B, or Hepatitis C infections.
• Have a history of severe lung disease or pneumonitis.
• Have active brain metastases unless stable and not requiring steroids.
• Have any condition or disorder that could affect participation in the study.