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A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioNTech SE

About this trial

The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the recommended dose of BNT3212 for use as monotherapy and with pumitamig (also known as BNT327 or PM8002) as combination therapy, in adults with advanced solid tumors who have exhausted other treatment options.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors that have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease; or for whom the standard therapy is considered inappropriate or intolerable.

Have at least one measurable lesion based on RECIST v1.1.

Eastern Cooperative Oncology Group performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).

Predicted life expectancy of ≥3 months.

Disqualifiers

Active infection (e.g., bacterial or fungal infections) requiring systemic treatment (e.g., severe pneumonia, bacteremia, sepsis), except oral antibiotics.

Participants with primary central nervous system (CNS) malignancies.

Active CNS metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.

Unstable pleural effusion or ascites requiring thoracentesis or paracentesis within 14 days prior to initiation of study treatment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BNT3212

    Biological/Vaccine

    Intravenous infusion

  • Pumitamig

    Biological/Vaccine

    Intravenous infusion

Treatment groups

375 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part A - BNT3212 monotherapy (dose escalation)Experimental treatment 1 intervention
Group B: Part B - BNT3212 monotherapy dose level (DL)1 (expansion cohort)Experimental treatment 1 intervention
Group C: Part B - BNT3212 monotherapy DL2 (expansion cohort)Experimental treatment 1 intervention
Group D: Part B - BNT3212 monotherapy DL3 (expansion cohort)Experimental treatment 1 intervention
Group E: Part C - BNT3212 + pumitamig combination therapy (dose escalation)Experimental treatment 2 interventions
Group F: Part D - BNT3212 DL1 + pumitamig combination therapy (expansion cohort)Experimental treatment 2 interventions
Group G: Part D - BNT3212 DL2 + pumitamig combination therapy (expansion cohort)Experimental treatment 2 interventions
Group H: Part D - BNT3212 DL3 + pumitamig combination therapy (expansion cohort)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Parts A and C - Occurrence of dose limiting toxicities (DLTs) within a participant during the DLT observation period

Per cohort.

Time frame
Up to 28 days after first dose of investigational medicinal product (IMP).
2

All parts - Percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship

Per cohort. Adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for AEs version 5.0 (NCI CTCAE v5.0).

Time frame
From the time of the first dose of IMP until 90 days after the last dose of IMP, approximately up to 31 months.
3

Parts A and C - Percentage of participants with dose interruptions or discontinuations of study treatment due to TEAEs

Per cohort.

Time frame
From the time of the first until last dose of IMP, approximately up to 31 months.
4

Parts B and D - Percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs

Per cohort.

Time frame
From the time of the first until last dose of IMP, approximately up to 31 months.

Secondary outcomes

1

All parts - PK assessment: Maximum concentration (Cmax) derived from serum/plasma concentrations

Per cohort. For BNT3212 (conjugated antibody, total antibody, and unconjugated derivative of camptothecin, topoisomerase I inhibitor \[iCPT\]) and for pumitamig if in the combination cohorts, as data permits.

Time frame
From predose to 28 days after first dose of IMP.
2

All parts - PK assessment: Area under the concentration-time curve (AUC0-t) derived from serum/plasma concentrations

Per cohort. For BNT3212 (conjugated antibody, total antibody, and unconjugated iCPT) and for pumitamig if in the combination cohorts, as data permits.

Time frame
From predose to 28 days after first dose of IMP.
3

All parts - PK assessment: Minimum concentration (Ctrough) derived from serum/plasma concentrations

Per cohort. For BNT3212 (conjugated antibody, total antibody, and unconjugated iCPT) and for pumitamig if in the combination cohorts, as data permits.

Time frame
From predose until 90 days after the last dose of IMP.
4

All parts - Anti-drug antibody (ADA) prevalence

Per cohort and by dose level, derived from serum samples. Prevalence defined as the percentage of participants who are ADA positive (either baseline or post baseline), if data permits.

Time frame
For up to 90 days from the last dose of IMP.

Other outcomes

Sponsors and contacts

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

BioNTech SE

Lead sponsor

Biotheus (Hengqin) Co., Ltd.

Collaborator

BioNTech (Shanghai) Pharmaceuticals Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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