PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PM8002, Chemotherapy Regimen 1, Chemotherapy Regimen 2, Chemotherapy Regimen 3.
- Who it may be relevant to
- Registry conditions: CRC (Colorectal Cancer). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
A multicenter, randomized, open-label study design is used, with a planned enrollment of 100 participants, 40 in the PM8002 (BNT327)+ chemotherapy regimen 1 group, 30 in the PM8002 (BNT327)+ chemotherapy regimen 2 group and 30 in the PM8002 (BNT327)+ chemotherapy regimen 3 group. The investigators make the decision on which chemotherapy regimen to be used in the participants. After combined chemotherapy regimen is confirmed, participants will be randomized to one of two dose levels of PM8002(BNT327) plus chemotherapy.
Interventions
- Drug PM8002
IV infusion - Drug Chemotherapy Regimen 1
IV infusion - Drug Chemotherapy Regimen 2
Oral administration and IV infusion - Drug Chemotherapy Regimen 3
IV infusion
Primary outcome measures
- Objective response rate (ORR) [Time frame: 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） [Time frame: From the first dose of the investigational medicinal product (IMP) to the 30-day Safety Follow-Up Visit]
Secondary outcome measures (5)
- Duration of response (DoR) [Time frame: Up to approximately 2 years]
- Disease control rate (DCR) [Time frame: Up to approximately 2 years]
- Time to response (TTR) [Time frame: Up to approximately 2 years]
- Progression free survival (PFS) [Time frame: Up to approximately 2 years]
- Overall survival (OS) [Time frame: Up to approximately 5 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 11 centers
- Peking University First Hospital — Beijing
- Sun Yat-sen University Cancer Center — Guangzhou
- Guangdong Provincial People's Hospital — Guangzhou
- Harbin Medical University Cancer Hospital — Harbin
- Hubei Cancer Hospital — Wuhan
- Jilin Cancer Hospital — Changchun
- Cancer Hospital of Shandong First Medical University — Jinan
- Fudan University Shanghai Cancer Center — Shanghai
- … and 3 more centers
Identifiers
NCT: NCT07133750 · PM8002-B018C-CRC-R