NCT07133750 PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
| NCT ID | NCT07133750 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Biotheus Inc. |
| Condition | CRC (Colorectal Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-08-19 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-08-19 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Ruihua Xu, PhD, MD
PRINCIPAL INVESTIGATOR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT07133750 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CRC (Colorectal Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07133750 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07133750 currently recruiting?
Yes, NCT07133750 is actively recruiting participants. Contact the research team at xuelian.xing@biontech.com for enrollment information.
Where is the NCT07133750 trial being conducted?
This trial is being conducted at Beijing, China, Guangzhou, China, Guangzhou, China, Harbin, China and 7 additional locations.
Who is sponsoring the NCT07133750 clinical trial?
NCT07133750 is sponsored by Biotheus Inc.. The principal investigator is Ruihua Xu, PhD, MD at Sun Yat-Sen University Cancer Center. The trial plans to enroll 100 participants.
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