Study on TJ102 for Treating Advanced Ovarian Cancer and Other Solid Tumors

Inclusion Criteria

• Have advanced or metastatic high-grade serous ovarian cancer, including cancer of the ovaries, fallopian tubes, or primary peritoneal cancer, that cannot be cured with surgery or radiotherapy and has worsened after the last treatment.
• Must have previously received a platinum-based chemotherapy regimen. If the cancer worsened during or within 6 months after the last platinum treatment, it is considered platinum-resistant. Patients with platinum-sensitive cancer may join Phase 1 if they have had at least two prior platinum treatments.
• Have received between one and four previous treatments for advanced or metastatic cancer and have not responded to, cannot tolerate, or are not eligible for standard treatments available locally. Previous treatment with certain drugs like mirvetuximab soravtansine or bevacizumab is allowed but not required.
• Have at least one tumor that can be measured by scans.
• Be 18 years or older.
• Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a life expectancy of at least 12 weeks.
• Have adequate organ function and meet specific lab test criteria within 7 days before the first dose.

Exclusion Criteria

• Have an allergy to any part of TJ102 or a history of severe allergic reactions to similar drugs.
• Have received more than two previous antibody-drug conjugate (ADC) treatments for advanced or metastatic cancer.
• Have been treated with certain ADCs containing specific drugs like eribulin.
• Have received certain chemotherapy or other cancer treatments too close to the start of the study.
• Have taken strong or moderate CYP3A4 inhibitors too close to the start of the study.
• Are currently in another clinical trial or have taken an investigational drug too close to the start of the study.
• Have not recovered from side effects of previous cancer treatments to a mild level.
• Have a history of lung disease that required steroids or current lung issues that cannot be ruled out by imaging.
• Have severe eye conditions that may increase the risk of eye damage.
• Have significant nerve damage or a history of severe nerve damage.
• Have uncontrolled or serious heart disease.
• Have active hepatitis B or C or HIV, unless the infection is controlled.
• Have had a severe infection requiring hospitalization or antibiotics too close to the start of the study.
• Have active cancer spread to the brain or spinal cord unless treated and stable.
• Have had another cancer within the last 3 years, except for certain non-threatening cancers.
• Are pregnant, breastfeeding, or planning to become pregnant.
• Have other factors that may affect participation in the study, such as other health conditions or unwillingness to follow study procedures.