Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141

Titre officiel

Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT141 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With CLDN18.2-positive Solid Tumours

Sommaire:

This trial is an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with CLDN18.2-positive tumours.

The trial design consists of three parts:

Part 1A is a dose escalation of BNT141 as monotherapy in patients with unresectable or metastatic Claudin 18.2 (CLDN18.2)-positive gastric cancer, gastroesophageal junction (GEJ) and esophageal cancer of the adenocarcinoma subtype, colorectal cancer, pancreatic cancer, biliary tract cancers, and mucinous ovarian cancer, for which there is no available standard therapy likely to confer clinical benefit, or the patient is not a candidate for such available therapy. The dose of BNT141 will be escalated until the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of BNT141 as monotherapy are defined.

Part 1B is a dose escalation of BNT141 in combination with nab-paclitaxel and gemcitabine in patients with advanced unresectable or metastatic CLDN18.2-positive pancreatic adenocarcinoma or cholangiocarcinoma who are eligible for treatment with nab-paclitaxel and gemcitabine. Part 1B intends to define the MTD and/or RP2D of the combination.

Part 2 with adaptive design elements will be added at a later stage.

Description de l'essai

Primary Outcome:

  • Occurrence of treatment-emergent adverse events (TEAEs) within a patient including Grade ≥ 3, serious, fatal TEAE by relationship
  • Occurrence of dose reductions and discontinuation of BNT141 due to TEAEs throughout the study and up to 60 days after last subject last treatment
  • Occurrence of dose-limiting toxicities (DLTs) within a patient during the DLT evaluation period
Secondary Outcome:
  • BNT141 pharmacokinetic: Area under the concentration time curve from 0 to infinity (AUC0-inf)
  • BNT141 pharmacokinetic: Area under the concentration time curve from 0 to time (AUC0-t)
  • BNT141 pharmacokinetic: Clearance (CL)
  • BNT141 pharmacokinetic: Volume of distribution (VD)
  • BNT141 pharmacokinetic: Maximum concentration of the drug (Cmax)
  • BNT141 pharmacokinetic: Time to maximum concentration (Tmax)
  • BNT141 pharmacokinetic: Concentration prior to next dose (Ctrough)
  • BNT141 pharmacokinetic: Minimum drug concentration observed after administration (Cmin)
  • BNT141 pharmacokinetic: Elimination half-life (t half)
  • BNT141 - Objective response rate (ORR)
  • BNT141 - Disease control rate (DCR)
  • BNT141 - Duration of response (DOR)
  • BNT141 - Anti-drug antibodies [ADAs] response

Voir cet essai sur ClinicalTrials.gov

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