NCT05756907

Who might be able to join this trial:

• You are 18 years of age or older at the time of signing the consent form.
• For the first part of the trial: You have a solid tumor cancer that has spread or cannot be removed with surgery, you have already tried the standard treatments available, and your doctor does not believe any remaining standard options would offer a reasonable benefit.
• For the second part of the trial (and certain groups in Part 1): You have platinum-resistant ovarian cancer — meaning your ovarian, fallopian tube, or abdominal lining cancer came back within 6 months of finishing a platinum-based chemotherapy. Your cancer must show signs of returning through measurable tumors on a scan, or through elevated CA125 blood levels along with fluid buildup or abnormal imaging findings.
• You are generally well enough to carry out light activity and care for yourself (this is measured on a standard scale used by doctors — confirm with trial site).
• Your liver, kidneys, blood cells, and other organs are working well enough, without needing growth factor support (confirm with trial site).
• If you could become pregnant, you must have a negative pregnancy test at the start of the trial and agree to use 2 highly effective forms of birth control during the study and for 30 days after your last dose.
• If you are not able to become pregnant — for example, due to a hysterectomy, removal of both ovaries, tubal ligation, or being past menopause for at least 1 year — you do not need to use contraception.
• If you are male, you and your female partner must use highly effective contraception if she could become pregnant, and you must not donate sperm during the study or for 90 days after your last dose.
• You are willing and able to sign the consent form and follow the study requirements.

Who may not be able to join:

• You have a known allergy to any ingredient in the study drug, or you have had a severe allergic or anaphylactic reaction in the past.
• You were hospitalized in the last 28 days for a bowel blockage, a serious cancer complication, or you had major surgery (planned non-urgent surgery is allowed if you have fully recovered).
• You have HIV-1 or HIV-2, or a history of Kaposi sarcoma or Multicentric Castleman Disease.
• You currently have an active liver disease, including active hepatitis A, B, or C. However, if you had hepatitis C and the virus is no longer detectable after treatment, or if you had hepatitis B and a specific blood test shows no virus present, you may still be eligible (confirm with trial site).
• You are currently pregnant or breastfeeding.
• You received a live or live-attenuated vaccine (such as certain flu or shingles vaccines) within 30 days before starting the study drug.
• You have had an active infection requiring prescription antibiotics, antiviral, or antifungal medication — including COVID-19 — within 14 days before starting the study drug.
• You have had a non-infectious illness that has not cleared up at least 14 days before starting the study.
• You have a history of, or are known or suspected to have, an autoimmune disease. Some exceptions apply — for example, vitiligo, Type 1 diabetes, childhood eczema that has resolved, or a thyroid condition that is currently well-controlled may be allowed (confirm with trial site).
• You have active cancer that has spread to the brain or the lining around the brain. If brain tumors were previously treated and have been stable for at least 4 weeks with no signs of growth, you may still be eligible (confirm with trial site).
• You still have significant side effects from previous cancer treatments that have not returned to normal or near-normal levels, with some exceptions such as hair loss, nerve damage, or a treated thyroid condition.
• You have received another experimental treatment within 21 days — or within 5 half-lives of that drug, whichever is shorter — before starting this study.
• You have received immunotherapy or checkpoint inhibitor treatment within the last 3 months or 5 half-lives of that drug, whichever is shorter.
• You have been taking steroid tablets or injections at a dose greater than 10 mg per day of prednisone (or equivalent) within the last 10 days. Steroid creams, nasal sprays