drugset / Trial / NCT05763004

A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IOS-1002 Administered Alone and in Combination With Pembrolizumab, a PD-1 Monoclonal Antibody in Advanced Solid Tumors

NCT05763004 ↗

Non-randomizedParallel-groupOpen-labelTreatment

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 dose 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 Antibody 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 advanced 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.

Timeline

Start
2023-03-15
Primary completion
2026-05-30
Completion
2026-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject IOS-1002 Unknown — —
Subject Pembrolizumab Monoclonal antibody — —

Indications