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Clinical Trials in China / NCT07133750
Recruiting Phase 2

PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

NCT07133750 · tracked via the Priya Life Science China tracker
Sponsor
Biotheus Inc.
Phase
Phase 2
Started
2025-08-19
Last updated
2026-07-23

Condition(s) studied

CRC (Colorectal Cancer)

Investigational drug(s) / intervention(s)

PM8002Chemotherapy Regimen 1Chemotherapy Regimen 2Chemotherapy Regimen 3

PM8002: IV infusion

Chemotherapy Regimen 1: IV infusion

Chemotherapy Regimen 2: Oral administration and IV infusion

Chemotherapy Regimen 3: IV infusion

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Guangdong Provincial People's Hospital Guangzhou Guangdong Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
Hubei Cancer Hospital Wuhan Hubei Recruiting
Jilin Cancer Hospital Changchun Jilin Recruiting
Cancer Hospital of Shandong First Medical University Jinan Shandong Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Recruiting
Sichuan Cancer Hospital Chengdu Sichuan Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07133750 on ClinicalTrials.gov ↗ ← All trials in China