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

Sponsor
ImmunOs Therapeutics AG
Study ID
NCT05763004
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

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

Interventions

  • IOS-1002 — DRUG
    monotherapy
  • IOS-1002 + KEYTRUDA® (pembrolizumab) — DRUG
    combination therapy

Study Details

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.

Key Dates

First listed
Mar 10, 2023
Start date
Mar 15, 2023
Status verified
Mar 2026
Primary completion
May 30, 2026
Completion
May 30, 2026

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IOS-1002 Monotherapy
  • Experimental: IOS-1002 Combination Therapy with KEYTRUDA® (pembrolizumab)

Primary Outcome Measure

To determine the incidence of treatment emergent Adverse Events (Safety and Tolerability) of various doses of IOS-1002 administered alone and/or in combination with a PD-1 mAb in subjects with advanced solid tumors [ Time Frame: From date of randomization until the date of first documented progression (end of study) or date of death from any cause, whichever came first, assessed up to 48 months ]

Related Studies