NCT05888857

MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.

A Multicentric Phase II Trial Evaluating MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicentric, prospective, multi-indication, single-treatment arm, open-label phase II trial assessing the efficacy of MEDI5752

Detailed description

Multicentric, prospective, multi-indication, single-treatment arm, open-label phase II trial assessing the efficacy of MEDI5752. Patients with mature tertiary lymphoid structures advanced solid tumors will be included in two independent cohorts: * Cohort A: patients with TLS+ IO-naïve solid tumor (miscellaneous) * Cohort B: patients with TLS+ PD1/PDL1-experienced solid tumor (miscellaneous) Each cohort will rely on a two-stage three-outcome design as described in Sargent et al.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	MEDI5752	A treatment cycle consists of 3 weeks. MEDI5752 will be administered by intravenous infusion at a fixed dose on Day 1 of each cycle

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-03-01
• Completion: 2028-09-01
• First posted: 2023-06-05
• Last updated: 2025-08-13

Locations

1 site across 1 country: France