Phase I Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Sep 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HRS-4642 for patients with advanced solid tumors that have a specific genetic change known as the KRAS G12D mutation. The main goal of the study is to find out how safe this treatment is and to determine the highest dose that patients can tolerate without serious side effects. The trial is currently recruiting participants who are at least 18 years old, have been diagnosed with this type of cancer, and have a good performance status, meaning they can carry out daily activities without much difficulty.

If you or someone you know is considering joining this study, participants can expect to take the study drug and undergo regular check-ups to monitor their health and any side effects. It's important to note that certain conditions, like having previously received specific cancer treatments or having certain health issues, may prevent someone from participating. Overall, this trial could help researchers learn more about how to treat this challenging type of cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
• • 2. Male or female ≥ 18 years old.
• • 3. Histologically confirmed diagnosis of advanced solid tumor harbouring with KRAS G12D mutation
• • 4. ECOG performance status of 0-1.
• • 5. With a life expectancy of ≥3 months.
• • 6. Have at least one measurable lesion.
• • 7. Adequate laboratory parameters during the screening period
• Exclusion Criteria:
• • 1. Previously received KRAS G12D inhibitors
• • 2. Priot radiotherapy within 28 days for non-thoracic radiation
• • 3. Prior anti-tumor chemotherapy (\< 6 weeks if chemotherapy including nitrosoureas or mitomycin) within 4 weeks before the study drug administration
• • 4. Any unresolved AEs \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or inclusion/exclusion criteria level (The investigators determined that safe and controllable toxicity was excluded, such as alopecia and ≤ grade 2 peripheral neuropathy ).
• • 5. Central nervous system (CNS) metastases
• • 6. Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
• • 7. Known history of hypersensitivity to any components of HRS-4642.
• • 8. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.