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
A Phase I/II, First-in-human, Open-label, Dose Escalation and Indication Expansion Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors
Sponsor: BioNTech SE + Biotheus (Hengqin) Co., Ltd., BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Parts A and C - Occurrence of dose limiting toxicities (DLTs) within a participant during the DLT observation period
Time frame: Up to 28 days after first dose of investigational medicinal product (IMP).
All parts - Percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship
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.
Parts A and C - Percentage of participants with dose interruptions or discontinuations of study treatment due to TEAEs
Time frame: From the time of the first until last dose of IMP, approximately up to 31 months.
Parts B and D - Percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs
Time frame: From the time of the first until last dose of IMP, approximately up to 31 months.
Secondary Endpoints
All parts - PK assessment: Maximum concentration (Cmax) derived from serum/plasma concentrations
All parts - PK assessment: Area under the concentration-time curve (AUC0-t) derived from serum/plasma concentrations
All parts - PK assessment: Minimum concentration (Ctrough) derived from serum/plasma concentrations
Eligibility Criteria
Key Inclusion Criteria: * 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. * Left ventricular ejection fraction ≥50% by either echocardiography or multigated acquisition scan within 28 days prior to first dose of study treatment. * Adequate liver, renal, hematological, and coagulation function. * Recovery to Grade 0-1 (or baseline) from adverse reactions relate…
Read full criteria on CT.gov →✦ Analyst Commentary
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