A Safety and Pharmacokinetic Phase I/Ib Study of AMC303 in Patients With Solid Tumours

  • STATUS
    Not Recruiting
  • participants needed
    55
  • sponsor
    amcure GmbH
Updated on 16 May 2021
Institut Catal d'Oncologia, Hospital Duran i Reynals (0.0 mi away) Contact

Summary

This is a two part Phase I/Ib, open-label, non-randomized and multi-center, dose escalation study with a 3+3 design (Part 1) and an expansion cohort at the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) (Part 2). If MTD is not reached in Part 1, RP2D will be determined after completion of Part 1 considering safety and tolerability, also beyond the dose limiting toxicity (DLT) period, pharmacokinetic (PK) and pharmacodynamic (PD) results.

Details
Condition Malignant Solid Tumor
Treatment AMC303
Clinical Study IdentifierNCT03009214
Sponsoramcure GmbH
Last Modified on16 May 2021

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