THE-0504 in Patients With Solid Tumors (NCT07646106) | Clinical Trial Compass
RecruitingPhase 1
THE-0504 in Patients With Solid Tumors
Italy30 participantsStarted 2024-11-13
Plain-language summary
Single-centre, open-label, dose escalation phase I clinical trial, designed to evaluate mainly the safety and tolerability of the antitumor drug THE-0504 in patients with different types of solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. written informed consent obtained;
. both gender adult (≥ 18 years) patients;
. diagnosis of solid tumor. Preferably, but non-limited, tumor types are the following: Small Cell Lung Cancer (SCLC), Colorectal Carcinoma (CRC), Pancreas Adenocarcinoma (PaAdCa), Gastric Cancer (GC) and Triple Negative Breast Cancer (TNBrCa);
. measurable metastatic disease or locally advanced unresectable tumors;
. have exhausted all EMA-approved treatment options;
. ECOG Performance Status graded as 0 or 1;
. patients able to understand the full nature and the purpose of the trial, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire trial (ability to attend all the planned trial visits according to the time limits included) based on Investigator's judgement;
. adequate liver function as assessed by following laboratory tests to be conducted within 28 days before the first dose of study treatment:
Exclusion criteria
. pregnant (as determined by a blood pregnancy test at the screening visit) or lactating women;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the maximum tolerated dose of THE-0504, what does that mean for what's currently known about its safety and whether it actually works against my specific cancer type?
2Given that the trial covers several different cancer types — including small cell lung cancer, colorectal, gastric, triple-negative breast cancer, and pancreatic adenocarcinoma — how does my particular diagnosis fit into what they're studying, and does that affect what I might experience?
3Because the primary goal here is figuring out safe dosing rather than proving the drug works, would you recommend I consider standard or established treatment options first before enrolling in a first-in-human type study like this?
4What kinds of side effects or dose-related risks are they watching for closely in this trial, and how would my health be monitored if I were to take part in dose-escalation testing?
5How intensive is the monitoring and visit schedule likely to be for a Phase 1 dose-finding study like this, and is that something that would realistically work with my current health situation and daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of Maximum Tolerated Dose (MTD)
Timeframe: From enrollment to completion of Cycle 1 (each cycle is 21 days)
2
Assessment of Recommended Phase 2 Dose (RP2D)
Timeframe: During dose escalation, at the end of cycle 1 (each cycle is 21 days)
. male patients who are willing to father children during the trial or in the 12 months after the end of IMP administration;
. additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy;
. have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but stable Grade 2 toxicities may be allowed to enrol after agreement between the Investigator and Sponsor;
. ECOG Performance Status \> 2;
. had not tolerated previously administered Top1 inhibitor treatments;
. known active CNS metastatic disease (patients with CNS metastases that are treated with radiotherapy and are stable for at least 28 days before study treatment start could be considered eligible);