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

Phase 1

Recruiting

• Conditions: ocally Advanced Solid Tumours; Locally Advanced Solid Tumours; Cancer - Any cancer

• Registration Number: ACTRN12623000956606
• Lead Sponsor: Antido Therapeutics (Australia) Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-04
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

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 Criteria

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified