PM8002 (BNT327) with chemotherapy in metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of PM8002 (BNT327), a bispecific antibody targeting PD-L1 and VEGF, when given with different chemotherapy regimens in adults with newly diagnosed, unresectable metastatic colorectal cancer. Participants are first assigned to a chemotherapy regimen, then randomized to two dose levels of PM8002 plus chemotherapy. The trial plans to enroll about 100 patients across three sites in China. Key outcomes will include response rate, progression-free survival, and safety signals to determine whether the combination warrants further study. Eligibility requires confirmed metastatic CRC, non-MSI-H/dMMR status, no prior systemic therapy for metastatic disease, measurable disease, and good performance status.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Signed informed consent form before any trial-related processes.
2. Age ≥ 18 years male or female.
3. Histologically or cytologically confirmed metastatic colorectal cancer (stage IV, UICC/AJCC staging system) that is not suitable for or cannot be radically resected surgically.
4. Participants must not have dMMR or MSI-H.
5. No prior systemic anti-tumor therapy for metastatic colorectal cancer.
6. have adequate organ function.
7. The investigator confirms at least one measurable lesion according to RECIST v1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed.
8. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.

Key Exclusion Criteria:

1. Received the following treatments or medications prior to starting study treatment:

   1. Received palliative local therapy, non-specific immunomodulatory therapy, or chineses herbal therapy with an anti-tumor indication within 14 days prior to study treatment.
   2. Treatment with systemic glucocorticoids (prednisone \>10 mg/day or equivalent dose of other glucocorticoids) or other immunosuppressive agents within 14 days prior to initiation of study treatment. Note: treatment with local, intraocular, intra-articular, intranasal, and inhaled glucocorticosteroids and short-term prophylactic use of glucocorticoids (e.g., to prevent allergy to contrast agent) are allowed.
2. Have a major coagulation disorder or other evidence of significant bleeding risk.
3. Adverse effects of prior antitumor therapy have not returned to a CTCAE 5.0 grade rating of ≤ grade 1
4. Have a serious non-healing wound, ulcer, or bone fracture.
5. History of abdominal fistula, gastrointestinal perforation, or abdominal abscess, history of gastrointestinal obstruction, or clinical signs of gastrointestinal obstruction within 6 months prior to initiation of study treatment.
6. Severe uncontrollable intra-abdominal inflammation that requires clinical intervention, in the judgment of the investigator.
7. Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• Hubei Cancer Hospital
  Wuhan, Hubei, China Recruiting
• Jilin Cancer Hospital
  Changchun, Jilin, China Recruiting

Study contacts

• Principal investigator: Ruihua Xu, PhD, MD — Sun Yat-Sen University Cancer Center
• Study coordinator: Xuelian Xing
• Email: xuelian.xing@biontech.com
• Phone: +86 18310237570

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.