Study on RNK05047 for Patients with Advanced Solid Tumors or Diffuse Large B-cell Lymphoma (CHAMP-1)

Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05487170

Provider View

This clinical trial is testing a new drug, RNK05047, to see if it is safe and effective for treating advanced solid tumors and diffuse large B-cell lymphoma. The study is divided into two parts to determine the best dose and to further explore its effects on different types of tumors.

Patient Parameters

Program Overview

This study is the first time RNK05047 is being tested in humans. It aims to find out if the drug is safe and how well it works for people with advanced solid tumors, including diffuse large B-cell lymphoma (DLBCL). The study is conducted in two parts: the first part focuses on finding the right dose, and the second part expands to include more patients to see how the drug works on different tumor types.

Description

In the first part of the study, participants will receive RNK05047 through an IV once a week for three weeks, followed by a week off. This cycle will help determine the safest and most effective dose. Initially, three participants will receive a starting dose of 0.75 mg/kg.

Once the best dose is identified, the second part of the study will begin. This phase will include more participants, divided into groups based on their type of cancer. Each group will have about 15 participants, and the study will look at how the drug affects different types of tumors. The expansion phase will be informed by the results from the first part and other scientific data.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic solid tumor.
  • Have tried all available standard treatments for advanced disease without success.
  • Have a tumor that can be measured.
  • Provide a sufficient tumor sample for analysis.
  • Be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a body mass index (BMI) of 18 or higher.
  • Have adequate liver, kidney, blood, and clotting function based on tests.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for four months after.
  • Men and women of childbearing potential must agree to use effective contraception during the study and for four months after the last dose.
  • Be able to understand the study requirements and provide written informed consent.

Exclusion Criteria

  • Currently receiving other cancer treatments, such as chemotherapy or radiation, unless enough time has passed since the last treatment.
  • Have side effects from previous cancer treatments that have not resolved to a mild level, except for mild hair loss.
  • Have active cancer spread to the brain or spinal fluid.
  • Have significant nerve damage.
  • Have active infections like HIV, HTLV-1, hepatitis B, or C.
  • Are pregnant or breastfeeding.
  • Have a history of another cancer unless it was treated with the intent to cure.

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