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

A Phase 1a/1b, First-in-human, Open-label, Non-randomized, Multicenter, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Efficacy, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of IOS 1002 Administered Alone and in Combination With Pembrolizumab, a PD-1 Monoclonal Antibody in Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: ImmunOs Therapeutics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	IOS-1002	monotherapy
DRUG	IOS-1002 + KEYTRUDA® (pembrolizumab)	combination therapy

Timeline

• Start date: 2023-03-15
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-03-10
• Last updated: 2026-03-27

Locations

5 sites across 1 country: Australia