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

ConditionCRC (Colorectal Cancer)
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PM8002

    Drug

    IV infusion

  • Chemotherapy Regimen 1

    Drug

    IV infusion

  • Chemotherapy Regimen 2

    Drug

    Oral administration and IV infusion

  • Chemotherapy Regimen 3

    Drug

    IV infusion

Treatment groups

100 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Chemotherapy regimen 1 group - PM8002 Dose 1 + chemotherapy regimen 1Experimental treatment 2 interventions
Group B: Chemotherapy regimen 1 group - PM8002 Dose 2 + chemotherapy regimen 1Experimental treatment 2 interventions
Group C: Chemotherapy regimen 2 group - PM8002 Dose 1 + chemotherapy regimen 2Experimental treatment 2 interventions
Group D: Chemotherapy regimen 2 group - PM8002 Dose 2 + chemotherapy regimen 2Experimental treatment 2 interventions
Group E: Chemotherapy regimen 3 group - PM8002 Dose 1 + chemotherapy regimen 3Experimental treatment 2 interventions
Group F: Chemotherapy regimen 3 group - PM8002 Dose 2 + chemotherapy regimen 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

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

Secondary outcomes

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.

Time frame
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.

Time frame
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).

Time frame
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).

Time frame
Up to approximately 2 years

Other outcomes

1

Pharmacokinetic (PK) parameters: maximum concentration

Maximum plasma concentration \[Cmax\] derived from serum concentrations of PM8002(BNT327) after study drug administration.

Time frame
Up to 30 days after last treatment
2

Pharmacokinetic (PK) parameters: minimum concentration

Minimum plasma concentration \[Cmin\] derived from serum concentrations of PM8002(BNT327) after study drug administration.

Time frame
Up to 30 days after last treatment
3

Anti-drug antibody (ADA)

the incidence of ADA to PM8002

Time frame
Up to 30 days after last treatment
4

PD-L1 expression, CD8+ TIL, gene mutations

PD-L1 expression in tumor and immune cells determined by IHC (immunohistochemistry), rate of CD8+ TIL determined by IHC, gene mutation type (including KRAS/NRAS/BRAF mutation)

Time frame
Up to approximately 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biotheus Inc.

Lead sponsor

BioNTech SE

Collaborator

Source ClinicalTrials.gov
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