Phase 1 Dose Escalation and Expansion to Evaluate AROG4-01 in Patients With Advanced Solid Tumors

Launched by AROMICS THERAPEUTICS · Oct 19, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new drug called AROG4-01 to see if it is safe and effective for patients with advanced solid tumors, such as mesothelioma, colorectal cancer, ovarian cancer, and advanced non-small cell lung cancer. The main goal is to find the right dose of the drug that helps patients who have run out of other treatment options. Participants will receive the drug through an intravenous (IV) infusion twice a week and will visit the clinic twice a week for checkups and tests. Once the best dose is determined, up to 20 patients will continue receiving that dose to see if they benefit from the treatment.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of an advanced solid tumor that cannot be treated with surgery or other standard therapies. They should also have measurable disease, meaning doctors can track how the tumor is responding to the treatment. Other important criteria include having a good performance status (meaning they are able to carry out daily activities) and no major health issues that could interfere with the study. This trial is currently not recruiting participants yet, so interested individuals will need to wait for further updates.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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).
• • 2. 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.
• • 3. ECOG performance status ≤ 2.
• • 4. Life expectancy ≥12 weeks.
• • 5. Hematology and clinical chemistry laboratory parameters within acceptable ranges.
• 6. Adequate organ function as defined below:
• • Hemoglobin ≥9 g/dL
• • Neutrophil count ≥1.000x10/mcL
• • Platelets ≥100.000/mcL
• • Total bilirubin ≤1,5 x Upper Limit of Normal (ULN) (unless Gilbert's Disease)
• • AST (SGOT)/ALT (SGPT) ≤ 2,5 x institutional ULN (or ≤ 5X ULN in the presence of liver metastases)
• • Creatinine ≤1.5 mg/dL and creatinine CL ≥40 mL/min (calculated using the Cockcroft-Gault formula)
• 7. Adequate coagulation profile as defined below:
• • INR≤ 1,5
• • aPTT ≤ 1,5 x ULN
• • Serum or urine negative pregnancy test for women with childbearing potential.
• • 8. No previous antitumor treatment (radiation therapy, systemic treatment, or surgery) in the previous 28 days and current adverse events from them ≤ grade 1.
• Exclusion Criteria:
• • 1. Systemic anti-cancer therapy within 4 weeks prior to study admission.
• • 2. Radiation therapy within 4 weeks prior to study entry.
• • 3. 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.
• • 4. 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, .
• • 5. Left ventricular ejection fraction below institutional normal limits.
• • 6. Patients with symptomatic central nervous system (CNS) primary tumor or metastases (including leptomeningeal carcinomatosis). Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the investigator.
• • 7. Breast feeding, pregnancy or not willing to adopt safe contraceptive measures by the patient or the patient's partner, to become pregnant during treatment or within 6 months after the end of treatment.
• • 8. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except HbsAc after vaccination) or hepatitis C infection.
• • 9. Any other diseases or medical condition that may interfere with the planned treatment, compliance, or place the patient at risk if participating in the study, at investigator criteria.