A phase I/II trial of IOMX-0675 a fully human monoclonal antibody selectively inhibiting LILRB1/2 alone or in combination with pembrolizumab in patients with previously treated advanced/metastatic solid tumors (LIMNOS)

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517449-14-00

Enrollment

110

Registered

2025-04-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced/metastatic solid tumors

Brief summary

Identification of a RP2D and combination dose of IOMX-0675 based on the comparative integration of this information across dose levels:, • Incidence of DLTs attributable to IOMX-0675 and pembrolizumab, where applicable, at each dose level and identification of a maximum tolerated dose (MTD)., • Type, incidence, and severity of treatment related AEs according to the NCI CTCAE version 5.0 at each dose level., • Calculation of at least the following parameters: Cmax, tmax, AUClast, t½ from concentration time information., • Maximum receptor occupancy, Dose selection will be further supported by:, • Observed clinical activity (see secondary endpoints), • Biomarker activity

Detailed description

Overall response rate (ORR), Duration of Response (DoR), Progression free survival (PFS)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Identification of a RP2D and combination dose of IOMX-0675 based on the comparative integration of this information across dose levels:, • Incidence of DLTs attributable to IOMX-0675 and pembrolizumab, where applicable, at each dose level and identification of a maximum tolerated dose (MTD)., • Type, incidence, and severity of treatment related AEs according to the NCI CTCAE version 5.0 at each dose level., • Calculation of at least the following parameters: Cmax, tmax, AUClast, t½ from concentration time information., • Maximum receptor occupancy, Dose selection will be further supported by:, • Observed clinical activity (see secondary endpoints), • Biomarker activity	—

Measure

Time frame

—

Secondary

Measure	Time frame
Overall response rate (ORR), Duration of Response (DoR), Progression free survival (PFS)	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026