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

Launched by RANOK THERAPEUTICS (HANGZHOU) CO., LTD. · Aug 2, 2022

Keywords

ClinConnect Summary

The CHAMP-1 clinical trial is studying a new treatment called RNK05047 for patients with advanced solid tumors, including a type of blood cancer known as diffuse large B-cell lymphoma (DLBCL). This trial is in its early stages, known as Phase 1, which means researchers are primarily focused on understanding how safe the treatment is, how it behaves in the body, and whether it shows any signs of effectiveness. The study involves giving RNK05047 through an intravenous (IV) infusion and will take place at multiple locations.

To participate in this trial, patients must have advanced cancer that has not responded to standard treatments and have measurable disease that can be tracked. Eligible participants should be between the ages of 65 and 74, and both men and women can join. They will need to meet certain health criteria and must agree to use effective birth control if they are of childbearing potential. Participants can expect to be closely monitored for their health and any side effects during the study. This trial is currently recruiting patients, offering a potential opportunity for those with limited treatment options.

Gender

ALL

Eligibility criteria

• 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