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CRC (Colorectal Cancer)Phase 2NCT07133750

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

A Phase 2 study testing PM8002, Chemotherapy Regimen 1 and Chemotherapy Regimen 2 in people with CRC (Colorectal Cancer), run by Biotheus Inc. at 11 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CRC (Colorectal Cancer)
What is being tested?
PM8002, Chemotherapy Regimen 1 and Chemotherapy Regimen 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
11 sitesChina
Study dates
19 Aug 2025to May 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xuelian Xing contact

+86 18310237570

xuelian.xing@biontech.com

11 sites in 1 country

China11 sites, 11 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Shikai Wu

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

    Changliang Yang

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

    Yongdong Jin

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ruihua Xu

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Yong Li

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Haijun Zhong

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Zhiwei Li

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Changzheng Li

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Zhiyu Chen

    Recruiting

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

    Peng Du

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Xinjun Liang

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
PM8002, Chemotherapy Regimen 1, Chemotherapy Regimen 2, Chemotherapy Regimen 3
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PM8002Drug

    Also called BNT327, Pumitamig

    IV infusion

  • Chemotherapy Regimen 1Drug

    IV infusion

  • Chemotherapy Regimen 2Drug

    Oral administration and IV infusion

  • Chemotherapy Regimen 3Drug

    IV infusion

Study groups in NCT07133750
Study groupRoleWhat they receive
Chemotherapy regimen 1 group - PM8002 Dose 1 + chemotherapy regimen 1ExperimentalSubjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression.
Receives: Drug: PM8002; Drug: Chemotherapy Regimen 1
Chemotherapy regimen 1 group - PM8002 Dose 2 + chemotherapy regimen 1ExperimentalSubjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression.
Receives: Drug: PM8002; Drug: Chemotherapy Regimen 1
Chemotherapy regimen 2 group - PM8002 Dose 1 + chemotherapy regimen 2ExperimentalSubjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression.
Receives: Drug: PM8002; Drug: Chemotherapy Regimen 2
Chemotherapy regimen 2 group - PM8002 Dose 2 + chemotherapy regimen 2ExperimentalSubjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression.
Receives: Drug: PM8002; Drug: Chemotherapy Regimen 2
Chemotherapy regimen 3 group - PM8002 Dose 1 + chemotherapy regimen 3ExperimentalSubjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 3 via intravenously (IV) Q2W until progression.
Receives: Drug: PM8002; Drug: Chemotherapy Regimen 3
Chemotherapy regimen 3 group - PM8002 Dose 2 + chemotherapy regimen 3ExperimentalSubjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 3 via intravenously (IV) Q2W until progression.
Receives: Drug: PM8002; Drug: Chemotherapy Regimen 3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 2 years

  2. 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.

    Measured: From the first dose of the investigational medicinal product (IMP) to the 30-day Safety Follow-Up Visit

Secondary outcomes (5)

  1. Duration of response (DoR)

    DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  2. Disease control rate (DCR)

    DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.

    Measured: Up to approximately 2 years

  3. Time to response (TTR)

    TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieve CR or PR (based on RECIST v1.1).

    Measured: Up to approximately 2 years

  4. Progression free survival (PFS)

    Progression free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).

    Measured: Up to approximately 2 years

  5. Overall survival (OS)

    OS is the time from the date of randomization or first dosing date to death due to any cause.

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start19 Aug 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07133750
Sponsor's protocol ID
PM8002-B018C-CRC-R
Status last verified
Jul 2026
First submitted
30 Jul 2025
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PM8002, Chemotherapy Regimen 1 and Chemotherapy Regimen 2 in people with CRC (Colorectal Cancer), run by Biotheus Inc. at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xuelian Xing (+86 18310237570, xuelian.xing@biontech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07133750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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