An Explorative Study of HRS-2189 Combined With Adebrelimab and BP102 for Metastatic Colorectal Cancer

Launched by FUDAN UNIVERSITY · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment—HRS-2189 together with Adebrelimab and BP102—for people with metastatic colorectal cancer, which means the cancer has spread beyond the colon or rectum. The main goal is to see if this treatment is safe and effective in helping control the disease.

Adults aged 18 to 75 with confirmed metastatic colorectal cancer and at least one tumor that can be measured may be eligible to join, as long as they have good overall health and are willing to participate. Before starting, patients should not have had recent major surgery, active infections, serious heart problems, or other cancers in the past five years (with some exceptions). Pregnant or breastfeeding women are not eligible. Participants will receive the study drugs and be closely monitored to understand how well the treatment works and to watch for any side effects. This study is not yet recruiting, so those interested should stay in touch with their healthcare providers for updates.

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Eligibility criteria

• Inclusion Criteria:
• • 1.18-75 years; 2.Histological confirmed metastatic colorectal cancer; 3.ECOG PS 0-1; 4.At least one measurable lesion (according to RECIST1.1); 5.Patients voluntarily enroll in the study.
• Exclusion Criteria:
• • 1. The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• • 2. Symptomatic brain or meningeal metastases (except for those whose BMS disease is stable for at least 4 weeks);
• • 3. Allergy to the study drug or any of its excipients;
• 4. Prior treatments or medications received before the first study treatment as follows:
• • 1. Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is allowed).
• • 2. Use of immunosuppressive drugs within 7 days before treatment, excluding intranasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10 mg/day of prednisone or an equivalent dose of other corticosteroids);
• • 3. Administration of immunomodulatory drugs (such as thymosin, interferon, interleukin) within 3 weeks before treatment;
• • 4. Vaccination with live attenuated vaccines within 28 days before treatment;
• • 5. Other systemic anti-tumor therapies within 28 days before treatment;
• • 5. Any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence;
• • 6. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• • 7. Active infection or unexplained fever \>38.5°C within 4 weeks before the first dose or on the day of the first dose (fever due to tumor may be included in the study at the investigator's discretion)；
• • 8. Within 6 months prior to study entry, any of the following conditions: myocardial infarction, severe/unstable angina, NYHA Class 2 or higher cardiac insufficiency, or clinically significant supraventricular/ventricular arrhythmia requiring clinical intervention; poorly controlled hypertension despite medication;
• • 9. History of severe bleeding (\>30 mL per episode) within 3 months, hemoptysis (\>5 mL per episode) within 1 month, or arterial/venous thrombotic events within 6 months before the first dose;
• • 10. Inability to swallow the study drug, or presence of factors affecting drug administration and absorption such as chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) or intestinal obstruction;
• • 11. Pregnant or breastfeeding women, or subjects of reproductive potential unwilling to use effective contraception;
• • 12. Presence of other severe physical or laboratory abnormalities that may increase the risk of study participation, interfere with study results, or patients deemed unsuitable for the study by the investigator.