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A Phase I, Open-label, Multicenter, First in Human Study to Evaluate the Safety and Tolerability of HH3806 in Patients with Advanced Malignancies

ACTRN 12622001339741

Brief Summary

This is a first in human study of a new potential treatment drug HH3806 for patients with relapsed/refractory NHL or advanced solid tumors. This study aims to determine the maximum safest dose of HH3806 that may be administered to cancer patients as a single therapy. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and to determine maximum safest dose of HH3806 that will be administered orally as a single therapy in adult patients with advanced malignancies.

Intervention/Treatment

  • Drug: HH3806.

Inclusion Criteria

  1. Male and female patients 18years of age or older.
  2. Provide informed consent voluntarily prior to initiation of any study-related procedures.
  3. Tumor type criteria: Histologically or cytologically confirmed diagnosis of one of the following advanced malignancy:
    • Solid tumors that meet the following criteria:
      • Measurable disease by RECIST v1.1 in at least 1 site with the exception of Castration-Resistant Prostate Cancer (CRPC), who may be enrolled with objective evidence of disease as per certain criteria; disease progression with the last line of therapy and at least one prior standard of care regimens, or for which there is no approved therapy, or for which standard therapy is unsuitable or refused. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. Patients without treatment options available known to provide clinical benefit are also eligible
    • Relapsed/refractory NHL must have received at least 2 prior systemic therapies and there is no standard salvage regimen available.
  4. Life expectancy greater than or equal to 3 months.
  5. ECOG performance status less than or equal to 1.
  6. Patient must have adequate organ function measured within 28 days of screening.

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