Linear Clinical Research | Perth, Australia
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About
The goal of this clinical trial is to learn about IOS-1002 in patients with solid tumors.
The main questions it aims to answer are:
The study will be conducted in 3 parts:
Enrollment
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Volunteers
Inclusion criteria
Age ≥18 years old at the time of Screening (signing the informed consent form [ICF]).
Histologically or cytologically confirmed advanced solid tumor (metastatic and/or unresectable) with measurable disease per RECIST v1.1:
For combination therapy dose-escalation: subjects who have undergone treatment with any agent specifically targeting checkpoint pathway inhibition (such as PD-1, PD-L1, PDL-2, LAG-3, or CTLA-4 antibody) for at least 3 months before disease progression and must have a gap of at least 4 weeks from the last treatment before receiving study treatment on Cycle 1 Day 1
a. Subjects who experienced prior Grade 1 to 2 checkpoint therapy-related immune mediated AEs must have confirmed recovery from these events at the time of study entry, other than endocrinopathies treated with supplementation. Where applicable, these subjects must also have completed steroid tapers for treatment of these AEs by a minimum of 14 days prior to commencing treatment with study therapy. b) Eligibility of subjects with prior Grade ≥3 checkpoint therapy-related immune AEs, will be considered on a case-by-case basis after discussion with the Medical Monitor (eg, asymptomatic isolated Grade 3 lipase elevations without clinical or radiological features of pancreatitis will be permitted to enrol).
Adequate organ function at Screening
Willingness to provide consent to allow the acquisition of fresh tumor biopsy and/or existing formalin tissue sample
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
140 participants in 2 patient groups
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Central trial contact
Claudia Berger
Data sourced from clinicaltrials.gov
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