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

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Apr 24, 2024

Keywords

ClinConnect Summary

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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 and ≤75 years old.
• • 3. ECOG performance status of 0-1.
• • 4. With a life expectancy of ≥12 weeks.
• • 5. With unresectable locally advanced or metastatic solid tumors harbouring with KRAS G12D mutation confirmed by central laboratory testing.
• • 6. Need to provided tumor tissue samples for genetic testing.
• • 7. Have at least one measurable lesion according to RECIST1.1, and the dose-escalation phase allows no measurable lesion.
• • 8. Adequate laboratory parameters during the screening period.
• Exclusion Criteria:
• • 1. Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis.
• • 2. Systemic antitumor therapy was received 4 weeks before the start of the study.
• • 3. Palliative radiotherapy was completed within 14 days before the first dose.
• • 4. Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria.
• • 5. Subjects with known or suspected interstitial pneumonia.
• • 6. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion.
• • 7. Have poorly controlled or severe cardiovascular disease.
• • 8. Subjects with active hepatitis B or active hepatitis C.
• • 9. A history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
• • 10. The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
• • 11. Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.