Study on SLC-3010 Alone and with Gemcitabine for Advanced Solid Tumors

Inclusion Criteria

• Have a confirmed diagnosis of a solid tumor that cannot be surgically removed, has spread, or has come back.
• For Part 1: Have any solid tumor that has not responded to standard treatments, or for which no standard treatment is available, or if the patient chooses not to undergo standard treatment.
• For Part 2: Have received at least one prior standard treatment for recurrent or metastatic cancer, and no other life-prolonging treatments are available or suitable.
• Have at least one tumor that can be measured by scans.
• Be 18 years or older.
• Be able to provide written consent and follow study procedures.
• Have a life expectancy of at least 3 months.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have adequate organ function based on specific medical tests.
• Have resolved any significant side effects from previous treatments to a mild level.
• Agree to use effective birth control methods during the study and for a specified period after the last dose of the study drug.
• Women of childbearing potential must have a negative pregnancy test before starting the study.

Exclusion Criteria

• Have another active cancer, except for certain skin cancers or other cancers that have been treated and not returned in the past 2 years.
• Have untreated or unstable brain metastases, unless treated and stable for at least 4 weeks.
• Have an immune deficiency or are taking immune-suppressing medications.
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Have had severe immune-related side effects from previous treatments.
• Have active infections like HIV or hepatitis B or C, unless under control.
• Have significant heart disease or recent heart attack.
• Have serious lung conditions or need oxygen support.
• Have received other cancer treatments recently.
• Are participating in another clinical trial or have recently completed one.
• Have had major surgery or radiation therapy recently.
• Have received live vaccines recently.
• Have a known allergy to the study drug or its components.
• Have any condition that could pose a risk or interfere with the study.
• Have psychiatric or substance abuse issues that could affect participation.
• Are pregnant or breastfeeding.