Advanced Solid TumorPhase 2TAYLORNCT05888857
MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.
A Phase 2 study testing MEDI5752 in people with Advanced Solid Tumor, run by Institut Bergonié at 1 site in France.
Trial summary
Multicentric, prospective, multi-indication, single-treatment arm, open-label phase II trial assessing the efficacy of MEDI5752 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- MEDI5752
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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),
- Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia of any grade (according to the NCI-CTCAE, version 5.0),
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry.
- Women and men must agree to use at least one medically highly effective method of contraception from screening, throughout the treatment period
- Voluntary signed and dated written informed consents prior to any specific study procedure,
- Patients with a social security in compliance with the French law.
Who cannot join
- 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,
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- 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,
- Cerebrovascular accident within 6 months prior to enrolment,
- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
- Active or history of autoimmune disease immune deficiency or inflammatory disorders, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, sarcoidosis syndrome, rheumatoid arthritis, hypophysitis, uveitis, inflammatory bowel disease, diverticulitis antiphospholipid antibody syndrome, Wegener granulomatosis, Graves'disease, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis,
- History of idiopathic pulmonary fibrosis, organizing pneumonia drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening CT scan.
- Evidence of the following infections: active infection including tuberculosis, HIV, active hepatitis B or C or A
- Any contraindication to biopsy for the research,
- Participation to a study involving a medical or therapeutic intervention in the last 30 days,
- Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia,
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment.
- Prior allogeneic stem cell or solid organ transplantation,
- Treatment with a live, attenuated vaccine within 30 days prior to initiation of study treatment
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic Immunosuppressive medication during study treatment,
- History of severe allergic anaphylactic reaction to chimeric or humanized antibodies or fusion proteins,
- Known hypersensitivity to Chinese hamster ovary cell products, to any component of the MEDI5752 formulation or to any human globulin therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Simone MATHOULIN-PELISSIER, MD, PhD contact
France1 site
Institut Bergonie
Bordeaux, 33076
Antoine ITALIANO, MD, PhD, a.italiano@bordeaux.unicancer.fr
About this study
Official title: A Multicentric Phase II Trial Evaluating MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.
Multicentric, prospective, multi-indication, single-treatment arm, open-label phase II trial assessing the efficacy of MEDI5752
Read the 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
- Being tested
- MEDI5752
- Keywords
- tertiary lymphoid structure, solid tumor, immunotherapy
- Medical subject headings
- Tertiary Lymphoid Structures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI5752Drug
A treatment cycle consists of 3 weeks. MEDI5752 will be administered by intravenous infusion at a fixed dose on Day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: patients with TLS+ IO-naïve solid tumors | Experimental | Participants with TLS+ IO-naïve solid tumors will be treated by MEDI5752 Receives: 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 Receives: Drug: MEDI5752 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: an expected average of 6 months
Secondary outcomes (13)
24-weeks clinical benefit rate (CBR) independently for each cohort
CBR is defined as the proportion of patients with clinical benefit at 6 months. Clinical benefit is defined as confirmed complete response, confirmed partial response or stable disease more than 24 weeks, defined as per RECIST v1.1.
Measured: 24 weeks
Best overall response (BoR) independently for each cohort
BoR is defined as the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation. The best overall response is determined once all the data for the participant is known (RECIST v1.1).
Measured: Throughout the treatment period, an expected average of 6 months
Duration of response (DoR) independently for each cohort
DoR is defined as the time from documentation of tumor response (complete response/partial response whichever is first recorded) to disease progression, according to RECIST v1.1. DoR will be assessed in responder (confirmed CR / PR) patients only.
Measured: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival (PFS), independently for each cohort
PFS is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first
Measured: 1 year
2-year progression-free survival (PFS), independently for each cohort
PFS is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first
Measured: 2 year
1-year overall survival (OS), independently for each cohort
OS is defined as the time from study treatment initiation to death (of any cause)
Measured: 1 year
2-year overall survival (OS), independently for each cohort
OS is defined as the time from study treatment initiation to death (of any cause)
Measured: 2 year
Safety profile, independently for each cohort: Common Terminology Criteria for Adverse Events version 5
Number of participants with toxicity graded using the Common Terminology Criteria for Adverse Events version 5
Measured: Throughout the treatment period, an expected average of 6 months
24-weeks clinical benefit rate (iCBR) independently for each cohort as per iRECIST
iCBR is defined as the rate of patients with iCR, iPR or immune stable disease (iSD)
Measured: 24 weeks
Duration of response (iDoR) independently for each cohort as per iRECIST
iDoR is defined as the time from the date of the first response iCR/iPR (whichever is first recorded) to the date of PD (iUPD confirmed as iCPD) as per iRECIST. iDOR is defined for subjects with iCR or iPR. If a patient has iPR (#1) followed by a iUPD (#1) which is not confirmed, then a iPR (#2) followed by a iUPD (#2) which is confirmed at the next assessment, then the iDOR is calculated from iPR1 until iUPD2
Measured: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival (iPFS), independently for each cohort as per iRECIST
- iPFS is defined as the time from study treatment initiation to the first occurrence of disease progression as per iRECIST or death (of any cause), whichever occurs first. The event date to be used for calculation of progression-free survival (iPFS) should be the first date at which progression criteria are met (ie, the date of iUPD) provided that iCPD is confirmed at the next assessment. If iUPD occurs, but is disregarded because of later iSD, iPR, or iCR, that iUPD date should not be used as the progression event date. If progression is not confirmed and there is no subsequent iSD, iPR, or iCR, then the iUPD date should still be used in the following scenarios: if the patient stops protocol treatment because they were not judged to be clinically stable, or no further response assessments are done (because of patient refusal, protocol noncompliance, or patient death); the next timepoint responses are all iUPD, and iCPD never occurs
Measured: 1 year
2-year progression-free survival (iPFS), independently for each cohort as per iRECIST
- iPFS is defined as the time from study treatment initiation to the first occurrence of disease progression as per iRECIST or death (of any cause), whichever occurs first. The event date to be used for calculation of progression-free survival (iPFS) should be the first date at which progression criteria are met (ie, the date of iUPD) provided that iCPD is confirmed at the next assessment. If iUPD occurs, but is disregarded because of later iSD, iPR, or iCR, that iUPD date should not be used as the progression event date. If progression is not confirmed and there is no subsequent iSD, iPR, or iCR, then the iUPD date should still be used in the following scenarios: if the patient stops protocol treatment because they were not judged to be clinically stable, or no further response assessments are done (because of patient refusal, protocol noncompliance, or patient death); the next timepoint responses are all iUPD, and iCPD never occurs
Measured: 2 year
iORR independently for each cohort
iORR is defined as the rate of patients with immune complete or partial responses (iCR, iPR) as per iRECIST. iCR and iPR can be assigned after iUPD (immune unconfirmed progressive disease) has been documented as per iRECIST (Seymour et al)
Measured: Throughout the treatment period, an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study startSep 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888857
- Sponsor's protocol ID
- IB2023-01
- Other IDs
- 2023-503451-94, 2023
- Acronym
- TAYLOR
- Status last verified
- Aug 2025
- First submitted
- 24 May 2023
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Phase II Trial Evaluating MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.
- ClinicalTrials.gov ID
- NCT05888857
- Acronym / sponsor ID
- TAYLOR / IB2023-01
- Conditions
- Advanced Solid Tumor
- Keywords
- tertiary lymphoid structure, solid tumor, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, AstraZeneca
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Cohort A: patients with TLS+ IO-naïve solid tumors | Experimental | Drug: MEDI5752Participants with TLS+ IO-naïve solid tumors will be treated by MEDI5752 |
| Cohort B: patients with TLS+ PD1/PDL1-experienced solid tumors | Experimental | Drug: MEDI5752Participants with TLS+ PD1/PDL1-experienced solid tumors will be treated by MEDI5752 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically confirmed solid tumor
- IO-naïve patients (cohort A) OR patients with secondary resistance to PD1/PDL1 inhibitors (cohort B),
- Patients in cohort B:
- 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,
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI5752A treatment cycle consists of 3 weeks. MEDI5752 will be administered by intravenous infusion at a fixed dose on Day 1 of each cycle | Drug | Cohort A: patients with TLS+ IO-naïve solid tumors, Cohort B: patients with TLS+ PD1/PDL1-experienced solid tumors |
Primary outcome
Assessment of the antitumor activity of MEDI5752 (independently for eah cohort)
Time frame: an expected average of 6 months
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.
13 secondary outcomes
24-weeks clinical benefit rate (CBR) independently for each cohort
Time frame: 24 weeks
Best overall response (BoR) independently for each cohort
Time frame: Throughout the treatment period, an expected average of 6 months
Duration of response (DoR) independently for each cohort
Time frame: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival (PFS), independently for each cohort
Time frame: 1 year
2-year progression-free survival (PFS), independently for each cohort
Time frame: 2 year
1-year overall survival (OS), independently for each cohort
Time frame: 1 year
2-year overall survival (OS), independently for each cohort
Time frame: 2 year
Safety profile, independently for each cohort: Common Terminology Criteria for Adverse Events version 5
Time frame: Throughout the treatment period, an expected average of 6 months
24-weeks clinical benefit rate (iCBR) independently for each cohort as per iRECIST
Time frame: 24 weeks
Duration of response (iDoR) independently for each cohort as per iRECIST
Time frame: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival (iPFS), independently for each cohort as per iRECIST
Time frame: 1 year
2-year progression-free survival (iPFS), independently for each cohort as per iRECIST
Time frame: 2 year
iORR independently for each cohort
Time frame: Throughout the treatment period, an expected average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simone MATHOULIN-PELISSIER, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI5752 in people with Advanced Solid Tumor, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine ITALIANO, MD, PhD (+33556333333, a.italiano@bordeaux.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the antitumor activity of MEDI5752 (independently for eah cohort) (time frame: an expected average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.