A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Chaperone-mediated Protein Degrader RNK05047 in Subjects With Advanced Solid Tumors (CHAMP-1)
This is a first in human, Phase 1/2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability, PK, PD and efficacy of RNK05047 when administered an intravenous (IV) infusion to subjects with advanced solid tumors, including diffuse large B-cell lymphoma (DLBCL). This is a 2-part study (dose escalation, cohort expansion) with sequential enrollment.
• 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.