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RecruitingLast updated: 20 February 2024

This study will assess the safety of a new drug (called AT-0174), how it interacts within the body, and will determine the maximum safe dose that may be administered to people with advanced solid cancersA Phase I Study to Evaluate the Safety, Tolerability, Pharmacology, and Preliminary Efficacy of AT-0174 in Subjects with Advanced Solid Malignancies

Clinical summary

Summary

This study will be conducted across two parts. It is recruiting people with advanced or metastatic solid cancers, including but not limited to:

  • non-small cell lung cancer
  • small cell lung cancer
  • triple-negative breast cancer
  • melanoma
  • stomach, gastro-oesophageal junction or oesophageal cancer
  • squamous cell cancer of the opesophagus
  • colorectal cancer
  • pancreas cancer
  • epithelial ovarian cancer (fallopian, ovarian, primary peritoneal cancer)
  • endometrial cancer
  • thyroid cancer (non-medullary)
  • moderate-high grade astrocytoma and glioblastoma multiforme

The researchers may decide to recruit people with other solid cancers, speak to your clinician or a recruiting trial unit for more information. 

In the first sub-study (Part 1), eligible participants will be allocated to the next available dosing cohort. The first cohort will be asked to take a daily oral capsule of the study drug (called AT-0174) for 7 days, followed by 3 weeks of no treatment. The second cohort will be asked to take a daily oral capsule of AT-0174 for 14 days, followed by 2 weeks of no treatment. The third cohort will be asked to take a daily oral capsule of AT-0174 for 28 days with no breaks.

In the second sub-study (Part 2), eligible participants will be allocated to the next available dosing cohort. This sub-study will ask all participants to take a daily oral capsule of AT-0174 for 28 days with no breaks. The dose of AT-0174 may increase in amount or frequency (e.g. twice per day) with each successive cohort in Part 2, based on careful assessment of the safety and tolerability of each dose.

All participants will have their vital signs checked and will provide blood and urine samples for testing. In addition, participants will have their cancer assessed using CT, MRI or CT/PET scans during the study. Participants may continue taking AT-0174 for as long as they and their doctor agree.

Conditions

This trial is treating patients with advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Antido Therapeutics (Australia) Pty Ltd,George Clinical Pty Ltd

Scientific Title

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

Eligibility

Inclusion

- Able to understand, sign, and commit to informed consent and to all study procedures
- 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.
- 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
- 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
- Eastern Cooperative Oncology (ECOG) performance status less than or equal to 1
- Life expectancy greater than or equal to 3 months
- Adhere to contraception requirements where applicable

Exclusion

- Prior radiotherapy within two weeks of treatment
- Treatment with anticancer therapies including cytotoxic chemotherapy, monoclonal antibodies (mAbs), and/or small molecule tyrosine kinase inhibitors within 14 days prior to study therapy administration, or 5 half-lives, whichever is shorter (42 days for prior nitrosourea or mitomycin-C)
- Major surgery within 28 days of the Screening visit
- Therapeutic radiopharmaceuticals within 8 weeks of treatment
- Systemic treatment with either corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the planned first dose of study drug
- Clinically significant gastrointestinal disorder that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
- Evidence or history of uncontrolled, clinically significant haematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation neurologic, dermatologic, autoimmune, or allergic disease
- Additional active malignancy that is progressing or has required active treatment within the past 3 years
- Known active CNS metastases and/or carcinomatous meningitis

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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