The goal of this clinical trial is to learn if drug AROG4-01 is safe in patients with solid tumors who have no available treatment alternative. Different doses will be tested in order to identify the most suitable one. Once it is identiffied, up to 20 patients will be treated with that dose, to check if thye get clinical benefit.
Participants will: receive intravenous administrations of ARG4-01 twice weekly, and visit the clinic twice every week for checkups and tests.
Male or female patients, 18 years or older, with a diagnosis (histology or citology) of advanced (unresectable or metastatic) solid tumor for which there is no curative therapy, has progressed on SOC treatment or for whom SOC is no longer an option. In part B patients will be included in different cohorts according to the histology (mesothelioma vs. non-mesothelioma).
Evaluable (part A) or measurable disease (part B) as per RECIST v1.1 (part A) or mRECIST v1.1. (part B). Progressive disease to the on or following the last line of antitumor treatment.
ECOG performance status ≤ 2.
Life expectancy ≥12 weeks.
Systemic anti-cancer therapy within 4 weeks prior to study admission.
Radiation therapy within 4 weeks prior to study entry.
Any major surgery within 4 weeks before first dose of study treatment No major surgery must be planned during the trial expected treatment. receiving study treatment. Participants with recent surgery with only local anesthesia may be included.
Non-malignant systemic disease including cerebrovascular accident, myocardial infarction in the last 6 months, unstable angina pectoris, unstable cardiac arrhythmia, New York Heart Association (NYHA) Class III or IV heart failure, coagulation abnormalities and clinically significant pulmonary compromise, .
Sequential
AROG4-01
DrugAROG4-01 will be administered as IV infusions in biweekly dosing interval. The first dosing day will be Day 1, 28 days cycle.
AROG4-01
DrugAROG4-01 will be administered as IV infusions in biweekly dosing interval. The first dosing day will be Day 1, 28 days cycle. This study is an open label, Phase 1 dose escalation trial with two expansion cohorts. The study consists of two parts: * Part A: Dose escalation in patients with advanced solid tumors. Approximately 8 to 20 patients in total will be enrolled in part A, covering up to 6 dose levels. * Part B: At the dose expansion phase, AROG4-01 two cohorts of ten patients with advanced solid tumor each will be recruited. One cohort of patients with advanced MPM (cohort 1) and a second cohort of patients with other solid tumors (cohort 2).
To evaluate the safety and tolerability of AROG4-01
To evaluate the safety and tolerability of AROG4-01 in adult patients with advanced solid tumors, including determination of the main DLT associated to AROG4-01. To assess the MTD (RP2D) defined as the highest dose at which no more than one in six patients experience a AROG4-01-related DLT. DLTs will be evaluated after the first treatment cycle.
To assess the preliminary antitumor activity of AROG4-01 monotherapy as measured by Overall Response Rate (ORR) according to standard criteria (RECIST 1.1 [18] or mRECIST v1.1
• To assess progression-free survival (PFS) in patients with mesothelioma and other advanced solid tumors.
To characterize the PK of AROG4-01.
Cmax
To characterize the PK of AROG4-01
half-life
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This trial is not recruiting at the moment. You can still explore other options:
