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PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

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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

NCT07133750•Biotheus Inc.

View on ClinicalTrials.gov

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.

Detailed Description

A multicenter, randomized, open-label study design is used, with a planned enrollment of 40 participants, 30 in the PM8002 (BNT327)+ chemotherapy regimen 1 group and 10 in the PM8002 (BNT327)+ chemotherapy regimen 2 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

August 1, 2025

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2029

Last Updated

August 21, 2025

Enrollment

ESTIMATED participants

Conditions

CRC (Colorectal Cancer)

Interventions

PM8002

DRUG

Chemotherapy Regimen 1

DRUG

Chemotherapy Regimen 2

DRUG

Contacts

Xuelian Xing

CONTACT

+86 18310237570 xing.xl@biotheus.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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