Brief Summary
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:
- To determine the safety and tolerability of various doses of IOS-1002 administered alone and/or in combination with KEYTRUDA® (pembrolizumab) in a single dosethe amount of medication taken escalation scheme
- To determine the safety, tolerability and efficacy of a selected dose of IOS-1002 administered every 2 weeks alone and in combination with a PD-1 Antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses
The study will be conducted in 3 parts:
- Part A (Phase 1a, monotherapy and combination therapy dose escalation): IOS-1002 alone and IOS-1002 plus PD-1 mAb in patients with advancedat a late stage, far along solid tumors
- Part B (Phase 1b, monotherapy cohort expansion): IOS-1002 alone in patients with advanced solid tumors
- Part C (Phase 1b, combination therapy cohort expansion): IOS-1002 plus PD-1 mAb in patients with advanced solid tumors.
Intervention / Treatment
- Drug: IOS-1002
- Drug: IOS-1002 + KEYTRUDA® (pembrolizumab)
Inclusion Criteria:
- Age ≥18 years old at the time of Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening (signing the informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. form [ICF]).
- Histologically or cytologically confirmed advanced solid tumor (metastatic and/or unresectable) with measurable disease per RECIST v1.1:
- Malignancy that has relapsed or is refractory to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists or for which the subjects who refuse or are ineligible for standard therapy.
- Subjects with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enrol provided the lesions have demonstrated clear progression and can be measured accurately.
- 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 1a. Subjects who experienced prior Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells 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 Monitorto check on, keep track of (eg, asymptomatic isolated Grade 3 lipase elevations without clinical or radiological features of pancreatitisinflammation of the pancreas will be permitted to enrol).
- Adequate organ function at Screening
- Willingness to provide consent to allow the acquisition of fresh tumor biopsyremoval of a section of tissue to analyse for cancer cells and/or existing formalin tissuea group of cells that work together to perform a function sample
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status 0 to 1.