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

In Part 1, enrolled subjects will receive IV RNK05047 once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week). The dose-escalation phase will follow a standard 3+3 design, with 3 subjects enrolled into the first dosing cohort to receive RNK05047 at the starting dose of 0.75 mg/kg.

In Part 2, once RP2D has been established, additional subjects (3 to 5 cohorts of approximately 15 subjects per cohort) will be enrolled in the cohort-expansion phase of the study. Tumor types for these cohorts will be determined based on data from the dose-escalation phase of the study and emerging results from preclinical studies or other scientific data. These dose expansion cohorts in all groups may be done concurrently.

Inclusion criteria

• 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.

Exclusion criteria

• 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
• Presence or suspicion of active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis
• Peripheral neurotoxicity ≥ Grade 2 according to CTCAE v5.0
• Known active infection with HIV, HTLV-1, hepatitis B or C
• Women who are pregnant or breastfeeding
• History of another malignancy unless the subject has been treated with curative intent for this malignancy