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โ† Trials
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PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

RecruitingPhase 2Ages 18 Years - anyAllBiotheus Inc.
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In plain words

What the trial is, and whether it could suit you

PM8002 (BNT327) is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II trial to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in first line MSS or MSI-L/pMMR metastatic colorectal cancer.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 1. Signed informed consent form before any trial-related processes. 2. Age โ‰ฅ 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 โ‰ค 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.
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What it tests

  • PM8002
  • Chemotherapy Regimen 1
  • Chemotherapy Regimen 2
  • Chemotherapy Regimen 3
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Where

11 sites
Peking University First Hospital
Beijing, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Hubei Cancer Hospital
Wuhan, China
Jilin Cancer Hospital
Changchun, China
Cancer Hospital of Shandong First Medical University
Jinan, China
Fudan University Shanghai Cancer Center
Shanghai, China

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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