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A modular, multi-part, multi-arm, open-label, Phase I/II Study to evaluate the safety and tolerability of GRWD5769 in patients with solid malignancies – Module 1.

ACTRN 12623000108617

Brief Summary

This study aims to assess a new cancer drug, GRWD5769, in patients with advanced cancer.

Intervention/Treatment

  • Drug: GRWD5769.

Inclusion Criteria

Module 1A, 1B & 1C

  1. Participant has cytologically or histologically confirmed locally advanced or metastatic solid malignancy for which no further standard of care (SoC) therapy is available (or no SoC therapy exists), or who have been offered and declined SoC therapy, or are intolerant of SoC therapy.
  2. Participant has measurable disease per RECIST 1.1/iRECIST.

    Module 1B specific

  3. Participant has at least one tumour lesion amenable to serial biopsies and is willing to provide consent for biopsies and has measurable disease per RECIST 1.1/iRECIST, excluding the lesion(s) identified for biopsy.

Module 1D specific
Additional selection criteria for Module 1 Part D will be described in a future protocol amendment.

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