PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
ConditionCRC (Colorectal Cancer)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiotheus Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- PM8002
- Chemotherapy Regimen 1
- Chemotherapy Regimen 2
Treatment groups
40 Participants
are divided into 4 treatment groupsSponsors and collaborators
Biotheus Inc.
Lead sponsor
BioNTech SE
Collaborator
Source ClinicalTrials.gov