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

Sponsor
Aromics Therapeutics
Study ID
NCT06652529
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Oct 22, 2024
Start date
Jan 31, 2025
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation
    Four dose levels will be tested. If there are no safety concerns, dose escalation may continue with up to two additional dose levels

Primary Outcome Measure

To evaluate the safety and tolerability of AROG4-01 [ Time Frame: 12 months ]

Central Contacts

Find similar trials

Nationwide
Colorectal cancer trialsOvarian cancer trialsOncology trialsGI oncology trialsGynecologic oncology trialsWomen's health trials

Related Studies