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Chemotherapy

MEDI5752 for Solid Cancers

Phase 1

Waitlist Available

Led By Deepa Subramaniam, MD, MSc

Research Sponsored by MedImmune LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment

Histologically or cytologically-confirmed advanced solid tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after the last patient starts treatment, whichever should occur first

Awards & highlights

Study Summary

This trial is testing a new drug, MEDI5752, against cancer. It will be given alone or with other drugs, to see if it is effective at treating cancer in adults.

Who is the study for?

Adults with advanced solid tumors who have a life expectancy of at least 12 weeks, can provide tumor material, and have adequate organ function. They must not be involved in the study's conduct or enrolled in another clinical trial. Participants need to use effective contraception and cannot have untreated brain metastases, uncontrolled illnesses, or a history of severe autoimmune disorders.Check my eligibility

What is being tested?

The trial is testing MEDI5752 alone or combined with chemotherapy drugs like carboplatin and pemetrexed or paclitaxel/nab-paclitaxel. It aims to see how well these treatments work for adults with various types of advanced solid tumors.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drug entering the body, fatigue, digestive issues such as nausea and diarrhea, blood cell count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is confirmed to be advanced and not just limited to one area.

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I am using a reliable birth control method.

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My organs and bone marrow are working well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of response through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of response through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of response through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Preliminary anti-tumor activitiy of MEDI5752 (versus pembrolizumab, where applicable) using Objective Response based on RECIST v1.1 (Dose-expansion phase)

The number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events (Dose-escalation phase)

The number of subjects experiencing abnormal laboratory evaluations (Dose-escalation phase)

+4 more

Secondary outcome measures

Neoplasms

PD-L1 Expression in subjects with advanced solid tumors

Pharmacokinetics of MEDI5752: AUC

+12 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: MEDI5752 and chemotherapyExperimental Treatment4 Interventions

MEDI5752, pemetrexed, carboplatin and paclitaxel.

Group II: Arm A: MEDI5752Experimental Treatment1 Intervention

MEDI5752

Group III: Arm C: Pembrolizumab and chemotherapyActive Control3 Interventions

pembrolizumab, pemetrexed, and carboplatin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemetrexed

2014

Completed Phase 3

~5250

Carboplatin

2014

Completed Phase 3

~6670

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

MedImmune LLCLead Sponsor

347 Previous Clinical Trials

793,508 Total Patients Enrolled

Deepa Subramaniam, MD, MScPrincipal InvestigatorAstraZeneca

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03530397 — Phase 1

Solid Tumors Research Study Groups: Arm A: MEDI5752, Arm B: MEDI5752 and chemotherapy, Arm C: Pembrolizumab and chemotherapy

Solid Tumors Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03530397 — Phase 1

Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03530397 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications do participants need to possess in order to be eligible for this trial?

"This clinical study is seeking 366 participants aged between 18 and 120 years old who have been diagnosed with advanced solid tumors. Furthermore, the trial stipulates additional conditions which potential volunteers must meet: For females of reproductive age that are sexually active, they must utilise a reliable form of contraception; males in this same situation should use condoms with spermicide. Those taking pemetrexed or carboplatin need to use birth control during their involvement as well as for an additional 6 months after it's concluded. Additionally, all subjects ought to possess at least one detectable lesion associated with their condition."

Answered by AI

What tangible results are being sought by this research project?

"This trial hopes to measure the frequency of treatment-related adverse events over a 114 day period. Secondary endpoints include determining MEDI5752's ability to generate an immune response in advanced solid tumour patients, assessing the duration of response and disease control according to RECIST v1.1 criteria and tracking any anti-drug antibodies present."

Answered by AI

Are there any ongoing recruitment opportunities for this research?

"Clinicaltrials.gov attests that this research trial is recruiting patients -- the first posting being on April 24th 2018 and its latest update occurring October 31st 2022."

Answered by AI

What conditions does MEDI5752 typically help alleviate?

"MEDI5752 has proven effective in treating malignant tumours, unresectable melanoma, and cases of microsatellite instability high."

Answered by AI

How many participants are being drawn into this investigation?

"Indeed, the clinicaltrial.gov website reveals that enrollment for this trial is currently in progress. First posted on April 24th 2018 and recently updated on October 31st 2022, 366 individuals need to be recruited from 7 different medical facilities."

Answered by AI

Has MEDI5752 been sanctioned by the FDA for therapeutic use?

"The safety of MEDI5752 is assigned a score of 1, as this is an early-stage trial and there are only limited clinical data assessing its efficacy or risk."

Answered by AI

In how many distinct venues is this investigation currently in progress?

"At the moment, this clinical trial is enrolling patients from 7 sites: Chattanooga, Detroit and Fairfax among other locales. To minimize travel needs if signing up for the study, it's best to pick a site that is closest to you."

Answered by AI

Does this trial offer access to elderly individuals over the age of 75?

"This research endeavor is seeking out participants aged 18 to 120. It must be noted that there are 391 trials available for minors and 3734 studies catering towards seniors."

Answered by AI

Has MEDI5752 been examined in other investigations?

"Currently, there are 1,596 active trials for MEDI5752 with 326 studies located in Phase 3. Shanghai is the most prominent city hosting these experiments; however, 74855 facilities worldwide have opened their doors to host clinical trials of this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors

2018. "A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03530397.

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