MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.

NCT05888857 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: IB2023-012023-503451-94
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor

Keywords

tertiary lymphoid structure; solid tumor; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Assessment of the antitumor activity of MEDI5752 (independently for eah cohort)

  Antitumor activity will be assessed in terms of objective response rate within 24 weeks based on RECIST v1.1, independently for each cohort, and based on centralized radiological review. Objective response under treatment is defined as patients with confirmed complete response or confirmed partial response, as per RECIST v1.1, observed during treatment with the investigational product. Objective response rate is defined as the proportion of patients alive with objective response based on RECIST v1.1. Objective response is recorded from study treatment initiation until the end of treatment.

  an expected average of 6 months

Secondary Outcomes (13)

• 24-weeks clinical benefit rate (CBR) independently for each cohort

  24 weeks

• Best overall response (BoR) independently for each cohort

  Throughout the treatment period, an expected average of 6 months

• Duration of response (DoR) independently for each cohort

  Throughout the treatment period, an expected average of 6 months

• 1-year progression-free survival (PFS), independently for each cohort

  1 year

• 2-year progression-free survival (PFS), independently for each cohort

  2 year

Study Arms (2)

Cohort A: patients with TLS+ IO-naïve solid tumors

EXPERIMENTAL

Participants with TLS+ IO-naïve solid tumors will be treated by MEDI5752

Drug: MEDI5752

Cohort B: patients with TLS+ PD1/PDL1-experienced solid tumors

EXPERIMENTAL

Participants with TLS+ PD1/PDL1-experienced solid tumors will be treated by MEDI5752

Drug: MEDI5752

Interventions

MEDI5752 DRUG

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

Cohort A: patients with TLS+ IO-naïve solid tumors; Cohort B: patients with TLS+ PD1/PDL1-experienced solid tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed solid tumor
• IO-naïve patients (cohort A) OR patients with secondary resistance to PD1/PDL1 inhibitors (cohort B),
• Patients in cohort B:
• have to be diagnosed previously treated with PD-L1/PD-1 inhibitors (investigational or approved),
• must have experienced initial clinical benefit (stable disease or better) from checkpoint inhibitor therapy for at least 4 months in which there was at least one interval scan prior to 4 months demonstrating no progression of disease.
• Presence of mature tertiary lymphoid structures (TLS) by IHC as described in protocol section 3.2.4. Except if presence of TLS has been already confirmed by Biopathological platform at Bergonié Institute, presence of TLS should be confirmed by central review based on FFPE tumor tissue sample,
• Advanced unresectable or metastatic solid disease,
• Measurable disease according to RECIST v1.1
• At least one tumor site that can be biopsied for research purpose,
• Age ≥ 18 years,
• Body weight \> 35 kg,
• ECOG ≤ 1,
• Life expectancy \> 3 months,
• Adequate hematological, renal, metabolic, hepatic and cardiac functions:
• Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment. Note that no more than three lines of systemic treatment for metastatic disease are allowed and that patients with oncogenic addiction must have progressed on prior approved regimens),

You may not qualify if:

• Any anticancer treatment within 21 days or 5 half-lives (whichever is shorter) prior to start of study treatment,
• Whole brain radiotherapy within 14 days prior to start of study treatment,
• Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
• Stereotactic radiosurgery within 7 days prior to start of study treatment,
• Major surgery within 4 weeks prior to start of study treatment or still recovering from prior surgery
• Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,
• History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
• Prior or concurrent malignant disease
• Any prior Grade ≥ 3 imAE while receiving immunotherapy or any unresolved imAE \> Grade 1
• For subjects who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 : Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy, must not have experienced a ≥ grade 3 imAE or an immune-related neurologic or ocular AE of any grade while receiving prior immunotherapy, must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, must not have experienced recurrence of an AE if rechallenged, and must not currently require maintenance doses of \> 10 mg prednisone or equivalent per day
• Symptomatic or actively progressing central nervous system metastases.
• History of leptomeningeal disease or cord compression
• Uncontrolled or symptomatic hypercalcemia
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiomyopathy of any etiology, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, history of myocardial infarction within the past 12 months, cardiac arrhythmia, ILD, serious chronic gastrointestinal conditions associated with diarrhea,

Sponsors & Collaborators

• Institut Bergonié: lead
• National Cancer Institute, France: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Institut Bergonie

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Tertiary Lymphoid Structures

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Antoine ITALIANO, MD, PhD

CONTACT

+33556333333; a.italiano@bordeaux.unicancer.fr

Simone MATHOULIN-PELISSIER, MD, PhD

CONTACT

s.mathoulin@bordeaux.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 independent single-arm, multicenter, phase II trials, based on a two-stage three-outcome design as described in Sargent et al. Cohort A : patients with TLS+ IO-naïve solid tumor (miscellaneous) Cohort B: patients with TLS+ PD1/PDL1-experienced solid tumor (miscellaneous)

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

FR (1)