BridgeMD
New treatment option for CRC (Colorectal Cancer)
Official title PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07133750
What this study is testing
What is PM8002?
PM8002 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for crc (colorectal cancer).
Also referred to as BNT327, Pumitamig.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Participants must not have dMMR or MSI-H.
- No prior systemic anti-tumor therapy for metastatic colorectal cancer.
You likely can't join 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...
- Treatment with systemic glucocorticoids (prednisone \>10 mg/day or equivalent dose of other glucocorticoids) or other immunosuppressive agents within...
- 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.
See the full eligibility criteria
- 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...
- The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1. Key
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Harbin, Heilongjiang, China
- Wuhan, Hubei, China
- Changchun, Jilin, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Harbin, Heilongjiang, China; Wuhan, Hubei, China; Changchun, Jilin, China; Jinan, Shandong, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.