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

NCT07133750 | Not Yet Recruiting Phase 2

• 1 other identifier: PM8002-B018C-CRC-R
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

CRC (Colorectal Cancer)

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 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

Study Arms (4)

Chemotherapy regimen 1 group - PM8002 Dose 1 + chemotherapy regimen 1

EXPERIMENTAL

Subjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression.

Drug: PM8002; Drug: Chemotherapy Regimen 1

Chemotherapy regimen 1 group - PM8002 Dose 2 + chemotherapy regimen 1

EXPERIMENTAL

Subjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression.

Drug: PM8002; Drug: Chemotherapy Regimen 1

Chemotherapy regimen 2 group - PM8002 Dose 1 + chemotherapy regimen 2

EXPERIMENTAL

Subjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression.

Drug: PM8002; Drug: Chemotherapy Regimen 2

Chemotherapy regimen 2 group - PM8002 Dose 2 + chemotherapy regimen 2

EXPERIMENTAL

Subjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression.

Drug: PM8002; Drug: Chemotherapy Regimen 2

Interventions

PM8002 DRUG

IV infusion

Also known as: BNT327

Chemotherapy regimen 1 group - PM8002 Dose 1 + chemotherapy regimen 1; Chemotherapy regimen 1 group - PM8002 Dose 2 + chemotherapy regimen 1; Chemotherapy regimen 2 group - PM8002 Dose 1 + chemotherapy regimen 2; Chemotherapy regimen 2 group - PM8002 Dose 2 + chemotherapy regimen 2

Chemotherapy Regimen 1 DRUG

IV infusion

Chemotherapy regimen 1 group - PM8002 Dose 1 + chemotherapy regimen 1; Chemotherapy regimen 1 group - PM8002 Dose 2 + chemotherapy regimen 1

Chemotherapy Regimen 2 DRUG

Oral administration and IV infusion

Chemotherapy regimen 2 group - PM8002 Dose 1 + chemotherapy regimen 2; Chemotherapy regimen 2 group - PM8002 Dose 2 + chemotherapy regimen 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Biotheus Inc.: lead
• BioNTech SE: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ruihua Xu, PhD, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuelian Xing

CONTACT

+86 18310237570; xing.xl@biotheus.com

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 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)