Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC

Launched by SHANGHAI HENLIUS BIOTECH · Feb 13, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a new treatment for patients with metastatic colorectal cancer (mCRC), which is cancer that has spread beyond the colon or rectum. The study is testing two different approaches: one group will receive a combination of two experimental medications (HLX07 and HLX10) along with a chemotherapy regimen called mFOLFOX6, while the other group will receive HLX07 alone. The goal is to see how well these treatments work and to evaluate any side effects they may cause.

To participate in this trial, you must be between 18 and 75 years old, have good organ function, and have been diagnosed with mCRC that has been confirmed through testing. You should also have a certain type of tumor genetics (specifically, no mutations in the KRAS, NRAS, or BRAF genes). If you have certain conditions, like HIV or a severe infection, or if you have had other cancers in the past two years (with some exceptions), you may not be eligible. While the trial is not yet recruiting participants, those who do join can expect to undergo regular check-ups and monitoring to assess how well the treatments are working and to ensure their safety throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age\>=18Y and ≤75Y
• • Good Organ Function
• • Expected survival time ≥ 3 months
• • mCRC that have been diagnosed histologically
• • KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue
• • ECOG score 0-1;
• Exclusion Criteria:
• • HIV infection
• • Active clinical severe infection;
• • A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.