NCT06652529

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

First in Human Phase 1 Dose Escalation and Expansion Clinical Trial to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of Intravenous AROG4-01 in Patients With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Aromics Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is an open label, Phase 1 dose escalation trial with two expansion cohorts to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of AROG4-01 in patients with mesothelioma and other advanced solid tumors. This clinical trial is divided into two parts: dose escalation (part A), and dose expansion (part B). Dose escalation In the present trial, patients will be enrolled sequentially into escalating dose cohorts, and will continue receiving AROG4-01 until disease progression, unacceptable toxicity, withdrawal of consent or otherwise as specified in the investigational medicinal product (IMP) discontinuation criteria. Patients in a dose cohort will receive AROG4-01 as intravenous (IV) administrations at the same dose in a dosing interval of twice a week, four weeks (equal to one cycle) consecutively without interruption, except when necessary to manage adverse events (AEs). Six cohorts at escalating dose levels are envisaged. Dose escalation may continue beyond, until the recommended for part B dose, which will be the recommended for phase 2 dose (RP2D), can be defined based on safety, preliminary efficacy, PK and PD data, based on the recommendations of the Safety Review Committee (SRC). The RP2D is defined as the recommended for phase 2 dose, but two cohorts will be treated as part of the phase 1 expansion with that particular dose, in order to get more safety and efficacy data. Escalation to the next dose level will occur following the SRC meeting for the most recently completed cohort. In considering the appropriate dose level for the next cohort the following will be applied: * The maximum dose increment will be limited to 100% if patients of a given cohort experience one Grade ≥ 2 AE during the DLT period or if at least one patient decreases \>10% weight. * The maximum dose increment will be limited to 50% if a patient of a given cohort experiences one DLT during the DLT period. If the prior circumstances do not occur, dose escalation will continue at higher increments (not exceeding three times prior dose level), as determined by the SRC. Extension phase At the dose expansion part, two cohorts of 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). Patients will be treated with AROG4-01 at the RP2D of AROG4-01 resulting from part A.

Conditions

• Solid Tumors (Phase 1)
• Mesothelioma
• Colorectal Carcinoma
• Ovarian Cancer
• NSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

Type	Name	Description
DRUG	AROG4-01	AROG4-01 will be administered as IV infusions in biweekly dosing interval. The first dosing day will be Day 1, 28 days cycle.
DRUG	AROG4-01	AROG4-01 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).

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-10-22
• Last updated: 2024-11-07