A Phase I Study to Evaluate the Safety, Tolerability, Pharmacology, and Preliminary Efficacy of AT-0174 in Subjects with Advanced Solid Malignancies

ACTRN 12623000956606

Brief Summary

This study will be conducted in two parts to assess the safety of AT-0174, how the treatment interacts within the body and to determine the maximum safe dose that may be administered to patients with advanced solid cancers.

Intervention / Treatment

  • AT-0174

Inclusion Criteria

  1. Able to understand, sign, and commit to informed consent and to all study procedures
  2. Histological/cytological evidence of one of the following unresectable locally advanced or metastatic solid cancers:
    a. Non-small cell lung carcinoma
    b. Small cell lung carcinoma
    c. Triple-negative breast carcinoma
    d. Malignant melanoma
    e. Gastric carcinoma/gastroesophageal junction carcinoma/esophageal adenocarcinoma
    f. Squamous cell carcinoma of the esophagus
    g. Colorectal carcinoma
    h. Pancreatic ductal adenocarcinoma
    i. Epithelial ovarian carcinoma (fallopian, ovarian, primary peritoneal carcinoma)
    j. Endometrial carcinoma
    k. Thyroid carcinoma (non-medullary)
    l. Moderate-high grade astrocytoma (oligodendroglioma, astrocytoma, or anaplastic astrocytoma [Grade 2 or 3] and glioblastoma multiforme [Grade 4])
    m. Other cancers based on the Investigator’s discretion with Sponsor Medical Monitor’s approval.
  3. Locally advanced unresectable or metastatic disease that is refractory to standard therapy, or for whom no standard therapy exists, and where standard therapy is contraindicated or has been declined by the patient
  4. Measurable or evaluable disease per RECIST v1.1, or Grades 2-4 astrocytoma as per RANO-HGG or RANO-LGG criteria, that was not in a prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy
  5. Eastern Cooperative Oncology (ECOG) performance status less than or equal to 1
  6. Life expectancy greater than or equal to 3 months
  7. Adhere to contraception requirements where applicable

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