ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer

Korábbi kezelés

• Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of stable hypothyroidism treated with hormone replacement therapy, alopecia or neurotoxicity.
• Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug.
• Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 months prior to the first dose of HS-20093
• Serious arteriovenous thrombosis events occurred within 3 months before the first dose.
• Severe infections occurred within 4 weeks before the first dose.
• Patients who have received continuous steroid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation
• Previous history of serious neurological or mental disorders, including epilepsy, dementia or severe depression and any other status that may interfere in assessment.
• Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
  • Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093

Más betegség

• History of other primary malignancies.
• Severe, uncontrolled or active cardiovascular diseases.
• Severe or poorly controlled hypertension.
• The presence of active infectious diseases has been known before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.
• Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
• Other moderate or severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.
• History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.
• Hypersensitivity to any ingredient of HS-20093.
• Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments

Laborértékek

• Treatment with any of the following:
  • Previous or current treatment with B7-H3 targeted therapy or ADCs with topoisomerase I inhibitors as the payload
  • Any cytotoxic chemotherapy, investigational agents and small molecule targeted therapy within 14 days prior to the first scheduled dose of HS-20093
  • Prior treatment with macromolecule anti-tumor therapy or other anticancer drugs within 28 days prior to the first scheduled dose of HS-20093
  • Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093
  • Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion
  • Major surgery within 4 weeks of the first dose of HS-20093
  • Spinal cord compression or brain metastases.
  • Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.
  • Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.

Egyéb

• Inadequate bone marrow reserve or organ dysfunction
• Evidence of cardiovascular risk.
• Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator

• At least age of 18 years at screening.
• Histologically or cytologically confirmed, locally advanced or metastatic colorectal cancer.
  • Dose escalation part will enroll advanced metastatic colorectal cancer patients who have progressed on or intolerant to standard therapies.
  • Dose expansion part will enroll advanced metastatic colorectal cancer patients who have not received prior treatment for advanced/metastatic colorectal cancer.
• At least one measurable lesion according to RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
• Life expectancy >= 12 weeks.
• Men or women should be using adequate contraceptive measures throughout the study.
• Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
• Signed and dated Informed Consent Form.