RecruitingPhase 1ACTRN12623000956606

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

Sponsor

Antido Therapeutics (Australia) Pty Ltd

Enrollment

33 participants

Start Date

Nov 15, 2023

Study Type

Interventional

Conditions

Locally Advanced Solid Tumours

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. Who is it for? You may be eligible for this study if you are aged 18 years or older and you have been diagnosed with a solid cancer, including but not limited to: non-small cell lung carcinoma, small cell lung carcinoma, triple-negative breast carcinoma, malignant melanoma, gastric carcinoma/gastroesophageal junction carcinoma/oesophageal cancer, colorectal carcinoma, pancreatic ductal adenocarcinoma, epithelial ovarian carcinoma (fallopian, ovarian, primary peritoneal carcinoma), endometrial carcinoma, thyroid carcinoma (non- medullary) or moderate-high grade astrocytoma (brain cancer). Study details This study will be conducted across two parts. In the first sub-study (Part 1), participants who choose to enrol in this study will be allocated to the next available dosing cohort. The first cohort will be asked to take a daily oral capsule of 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 of 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), participants who choose to enrol in this study 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 a careful assessment of the safety and tolerability of each dose. All participants will have their vital signs (heart rate, blood pressure, temperature, etc) 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. It is hoped this research will determine the maximum dose of AT-0174 that can be administered safely without causing severe reactions. Once the safest maximum dose of AT-0174 has been determined, a larger trial investigating the efficacy of AT-0174 as a treatment for a greater number of cancer patients may proceed.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This early-phase clinical trial is testing a new experimental cancer drug called AT-0174 for the first time in people. AT-0174 is designed to target a specific molecular pathway involved in cancer cell growth. The main goal of this study is to find out what dose is safe, how the drug behaves in the body, and whether it shows any early signs of effectiveness against advanced solid tumours that have not responded to standard treatments. The study is conducted in two parts with increasing doses tested in small groups of patients to carefully monitor for side effects. Participants take AT-0174 as a daily oral capsule, with the schedule varying by cohort. Regular blood tests, urine tests, and cancer imaging scans (CT, MRI, or PET) are performed throughout. Participants may continue as long as their doctor believes they are benefiting. You may be eligible if you are 18 or older with an advanced solid cancer (including lung, breast, melanoma, bowel, ovarian, endometrial, pancreatic, or brain cancer) that has stopped responding to standard therapy. You must have a good functional status and a life expectancy of at least 3 months. People with active brain metastases, very recent surgery or radiation, or those on corticosteroids are generally not eligible. The study is sponsored by Antido Therapeutics.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Treatment cycles will be 28 days in duration and may continue as long as the participant agrees and is tolerating treatment, and if there is potential clinical benefit as determined by the Investigator. Each cohort will be assessed for dose-limiting toxicities during the first 28 days before enrolment commences in the next cohort. Separate participants will be enrolled into each cohort but may escalate to the next dosing duration or level if it is found to be safe and at Investigator's discretion. Treatment adherence will be assessed using daily dosing diaries and the return of unused capsules after each cycle. In Part 1, AT-0174 will be administered orally, once daily at a dose of 50 mg once daily for 7 days followed by a 21-day safety observation or follow-up period (Cohort 1). The duration of AT-0174 (50 mg) treatment will then be prolonged to 14 consecutive days (Cohort 2) and then 28 consecutive days (Cohort 3) in each 28-day cycle. In Part 2, AT-0174 will be administered once daily as an oral capsule for 28 consecutive days of each 28-day cycle. The dose level will be escalated across up to 3 cohorts in Part 2, with the exact dose in each cohort to be selected based on the safety and tolerability of AT-0174 in previous cohorts. Enrolment into Part 2 will commence following the safety review of Cohort 3 data.

Locations(5)

Sunshine Coast University Private Hospital - Birtinya

NSW,QLD,SA,VIC, Australia

Southside Cancer Care Centre - Miranda

NSW,QLD,SA,VIC, Australia

Ballarat Health Services (Base Hospital) - Ballarat Central

NSW,QLD,SA,VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

NSW,QLD,SA,VIC, Australia

Cancer Research SA - Adelaide

NSW,QLD,SA,VIC, Australia

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ACTRN12623000956606