Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
This is an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic (PK)
and pharmacodynamic (PD) trial of BNT151 with expansion cohorts in various solid tumor
indications. The trial consists of Part 1, Part 2A and Part 2B with adaptive design elements:
The monotherapy dose escalation, (Part 1) of this clinical trial will enroll patients with
various solid tumors that are metastatic or of advanced unresectable stage for whom there is
no available standard therapy likely to confer clinical benefit, or patients who are not
candidates for such available therapy. The Part 1 of the trial also plans to implement a
dedicated biomarker cohort in BNT151 monotherapy: The Biomarker Cohort will recruit patients
at selected sites in the US only. The objective of the cohort is to observe PD activity and
drug-induced changes in the blood and tumor.
During combination dose escalation (Part 2A), patients of different specific solid tumors
(one cohort per indication) will be enrolled and treated with a combination of BNT151 and the
respective standard of care (SoC) treatment.
Part 2B is the expansion phase where a predefined number of patients in each indication
cohort will be treated with the confirmed recommended phase II dose (RP2D) of BNT151 in
combination with respective SoC.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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