Study on RNK08954 for Patients with Advanced Solid Tumors with KRAS G12D Mutation

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

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06667544

Provider View

This clinical trial is testing a new drug, RNK08954, to find the best dose and see if it can help treat advanced solid tumors with a specific KRAS G12D mutation. The study will evaluate the safety and effectiveness of the drug in patients who have already tried standard treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment, RNK08954, for patients with advanced solid tumors that have a specific genetic mutation called KRAS G12D. The trial is divided into two parts: the first part will determine the safest and most effective dose, while the second part will test this dose in different types of cancer, including colorectal and pancreatic cancer. Participants will take the drug orally and be monitored for safety and how well the treatment works.

Description

In the first phase of the study, participants will take RNK08954 by mouth every day. The initial part will involve a small number of patients to find the right dose. Once the best dose is identified, more patients will join to test the drug in different types of cancer, such as colorectal and pancreatic cancer. In the second phase, the study will compare two different doses to find the most effective one.

Participants will need to have a specific mutation in their cancer, known as KRAS G12D, and must have tried other standard treatments before joining the study. The study will involve regular health checks and tests to monitor the drug's effects and ensure safety.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced cancer with a KRAS G12D mutation confirmed by genetic testing.
  • Have tried standard treatments for their cancer type or are unlikely to benefit from them.
  • Have at least one tumor that can be measured by scans.
  • Provide a tumor sample for testing.
  • Be in good overall health with a performance status of 0 or 1.
  • Be able to take oral medication and keep a daily record of taking the drug.
  • Have adequate blood counts and organ function based on specific lab tests.
  • Have a life expectancy of more than 12 weeks.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men and women must agree to use contraception during the study and for six months after.
  • Understand and agree to the study requirements and provide written consent.

Exclusion Criteria

  • Currently receiving other cancer treatments within a certain timeframe before starting the study.
  • Significant decline in health status before starting the study.
  • Active or untreated brain metastases.
  • Unresolved side effects from previous cancer treatments.
  • Prior radiation to the only measurable tumor unless it has progressed.
  • Conditions affecting the ability to take oral medication, such as severe digestive issues.
  • Recent significant heart problems or long QT syndrome.
  • Use of certain medications that may interact with RNK08954.
  • Pregnant or breastfeeding women.
  • Untreated HIV or active infections requiring treatment.
  • Known hepatitis B or C infections unless under control.
  • Allergies to the study drug components.
  • Other serious medical conditions that may interfere with the study.
  • Previous treatment with KRAS G12D or Pan KRAS inhibitors.

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