PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
A Phase II, Multicenter, Open Label, Parallel Cohort Clinical Trial to Evaluate the Efficacy and Safety of PM8002 (BNT327) in Combination With Chemotherapy in First Line MSS or MSI-L/pMMR Metastatic Colorectal Cancer
1 other identifier
interventional
100
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2025
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2025
CompletedStudy Start
First participant enrolled
August 19, 2025
CompletedFirst Posted
Study publicly available on registry
August 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
July 23, 2026
July 1, 2026
1.7 years
July 30, 2025
July 22, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Objective response rate (ORR)
Objective response rate is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Up to approximately 2 years
Occurrence and severity of TEAE (treatment emergent adverse event), TRAE（treatment related adverse event）, TESAE (treatment emergent serious adverse event）, TRSAE (treatment related serious adverse event）
AEs are graded according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 in the combination treatment regimen.
From the first dose of the investigational medicinal product (IMP) to the 30-day Safety Follow-Up Visit
Secondary Outcomes (5)
Duration of response (DoR)
Up to approximately 2 years
Disease control rate (DCR)
Up to approximately 2 years
Time to response (TTR)
Up to approximately 2 years
Progression free survival (PFS)
Up to approximately 2 years
Overall survival (OS)
Up to approximately 5 years
Other Outcomes (4)
Pharmacokinetic (PK) parameters: maximum concentration
Up to 30 days after last treatment
Pharmacokinetic (PK) parameters: minimum concentration
Up to 30 days after last treatment
Anti-drug antibody (ADA)
Up to 30 days after last treatment
- +1 more other outcomes
Study Arms (6)
Chemotherapy regimen 1 group - PM8002 Dose 1 + chemotherapy regimen 1
EXPERIMENTALSubjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression.
Chemotherapy regimen 1 group - PM8002 Dose 2 + chemotherapy regimen 1
EXPERIMENTALSubjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression.
Chemotherapy regimen 2 group - PM8002 Dose 1 + chemotherapy regimen 2
EXPERIMENTALSubjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression.
Chemotherapy regimen 2 group - PM8002 Dose 2 + chemotherapy regimen 2
EXPERIMENTALSubjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression.
Chemotherapy regimen 3 group - PM8002 Dose 1 + chemotherapy regimen 3
EXPERIMENTALSubjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 3 via intravenously (IV) Q2W until progression.
Chemotherapy regimen 3 group - PM8002 Dose 2 + chemotherapy regimen 3
EXPERIMENTALSubjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 3 via intravenously (IV) Q2W until progression.
Interventions
IV infusion
IV infusion
Oral administration and IV infusion
IV infusion
Eligibility Criteria
You may qualify if:
- Signed informed consent form before any trial-related processes.
- Age ≥ 18 years male or female.
- Histologically or cytologically confirmed metastatic colorectal cancer (stage IV, UICC/AJCC staging system) that is not suitable for or cannot be radically resected surgically.
- Participants must not have dMMR or MSI-H.
- No prior systemic anti-tumor therapy for metastatic colorectal cancer.
- have adequate organ function.
- 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.
- The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.
You may not qualify if:
- Received the following treatments or medications prior to starting study treatment:
- Received palliative local therapy, non-specific immunomodulatory therapy, or chineses herbal therapy with an anti-tumor indication within 14 days prior to study treatment.
- 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.
- Have a major coagulation disorder or other evidence of significant bleeding risk.
- Adverse effects of prior antitumor therapy have not returned to a CTCAE 5.0 grade rating of ≤ grade 1
- Have a serious non-healing wound, ulcer, or bone fracture.
- 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.
- Severe uncontrollable intra-abdominal inflammation that requires clinical intervention, in the judgment of the investigator.
- Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotheus Inc.lead
- BioNTech SEcollaborator
Study Sites (11)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruihua Xu, PhD, MD
Sun Yat-Sen University Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2025
First Posted
August 21, 2025
Study Start
August 19, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2030
Last Updated
July 23, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share