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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2029-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer

NCT07079631

Metastatic Colorectal Cancer

RECRUITING PHASE1/PHASE2

Exploring Sintilimab + Bevacizumab + Decitabine for Advanced pMMR/MSS Colorectal Cancer (After 2+ Prior Therapies）

NCT07007767

Colorectal Cancer Metastatic

NOT_YET_RECRUITING PHASE2

Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC

NCT07003022

Colo-rectal Cancer MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers

RECRUITING PHASE2

MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer

NCT03531632

Colorectal Cancer Metastatic

COMPLETED PHASE1/PHASE2

Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment

NCT02226289

Neoplasm Colorectal Cancer Metastatic Neoplasm

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

CRC (Colorectal Cancer)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Oral administration and IV infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PM8002

IV infusion

Intervention Type DRUG

Chemotherapy Regimen 1

IV infusion

Intervention Type DRUG

Chemotherapy Regimen 2

Oral administration and IV infusion

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BNT327

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No