A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)

Korábbi kezelés

• Concurrent anticancer therapy: Radiotherapy, chemotherapy, biological therapy, or other anticancer investigational agents NOTE: at least 5 half-lives must have been ensued for any prior systemic cancer therapy agent before subject received the study drug on Day 1
• Unresolved toxicities from prior anticancer therapy, defined as not having resolved according to CTCAE version 5.0 Grade ≤ 1, excluding Grade 1 alopecia

Más betegség

• Known active infection with HIV, HTLV-1, hepatitis B or C
• History of another malignancy unless the subject has been treated with curative intent for this malignancy

Egyéb

• Presence or suspicion of active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis
• Peripheral neurotoxicity ≥ Grade 2 according to CTCAE v5.0
• Women who are pregnant or breastfeeding

• Pathologically documented locally advanced or metastatic solid tumor
• Refractory or intolerant to all available standard-of-care therapies for advanced disease
• Measurable disease
• Archived tumor tissue collected
• ECOG Performance Status of 0 or 1
• BMI ≥ 18 kg/m2
• Adequate liver, renal, hematologic, and coagulation parameters
• Negative serum pregnancy test (for women of childbearing potential) at Screening and a negative urine or serum pregnancy test on Day 1 prior to the first infusion
• Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 4 months after the last dose of study treatment.
• Must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.