TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer

Launched by SUZHOU TELIGENE LTD. · Sep 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two medications, TL938 and trastuzumab, to see how well they work for patients with a specific type of colorectal cancer called HER2-positive metastatic colorectal cancer. This type of cancer has spread to other parts of the body and cannot be surgically removed. The trial aims to find the best dose of these medications and to evaluate their effectiveness in treating this challenging condition.

To participate in this trial, patients need to be at least 18 years old and have HER2-positive, advanced colorectal cancer that hasn't responded to previous treatments. They should also have measurable cancer that can be tracked during the study. Participants will undergo evaluations to ensure they are healthy enough for the trial and have a good chance of benefiting from the treatment. It’s important to note that patients who have had certain prior treatments or have specific health issues may not be eligible. Those who join the trial can expect close monitoring throughout the study as researchers assess how well the medications are working.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years old and above, male or female;
• • 2. Her2-positive, RAS wild-type, unresectable or metastatic colorectal cancer and prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb). Patients whose tumors were deficient in mismatch repair (dMMR) proteins or were microsatellite instability-high (MSI-H) must also have received an ant-programmed cell death protain-1 mAb;
• • 3. At least one measurable lesion;
• • 4. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2;
• • 5. A minimum life expectancy of \>3 months;
• • 6. Adequate bone marrow reserve, hepatic, renal, and coagulation function;
• • 7. Other inclusion criteria apply for participating in the Study. -
• Exclusion Criteria:
• • 1. Prior anti-HER2 targeting therapy;
• • 2. Any systemic ant-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for nan-target lesions used to relieve symptoms within 2 weeks prior to enrollment;
• • 3. Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haIf-lives from the last dose of IP (whichever is shorter);
• • 4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment;
• • 5. Any unresolved toxicities from prior therapy greater than Grada 1, at the time of screening;
• • 6. Active central nervous system (CNS) metastases. Asymptomatic CNS metastases with no steroid use within the last 30 days prior to enrollment is eligible;
• • 7. Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low risk cancer such as low grade prostate cancer or ductal carcinoma in situ of the breast;
• • 8. Any active infection which has not been controlled at screening;
• • 9. Other exclusion criteria apply for participating in the Study. -