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Monoclonal Antibodies

MEDI5395 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by MedImmune LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of medi5395 through 14.4 months (corresponding to maximum observed duration)
Awards & highlights

Study Summary

This trial will test the effectiveness and safety of MEDI5395 in combination with durvalumab for the treatment of solid tumors.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of medi5395 through 14.4 months (corresponding to maximum observed duration)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of medi5395 through 14.4 months (corresponding to maximum observed duration) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Maximum Reduction From Baseline in Global Longitudinal Strain (GLS) Values
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs
+7 more
Secondary outcome measures
Duration of Response (DoR) per RECIST v1.1
Number of Participants With Positive Neutralizing Antibodies (nAbs) to MEDI5395
Overall Survival (OS)
+8 more

Side effects data

From 2022 Phase 3 trial • 867 Patients • NCT03084471
26%
Asthenia
20%
Anaemia
20%
Constipation
17%
Decreased appetite
16%
Diarrhoea
15%
Nausea
13%
Pruritus
10%
Urinary tract infection
10%
Cough
10%
Fatigue
9%
Vomiting
9%
Dyspnoea
9%
Back pain
9%
Oedema peripheral
9%
Pyrexia
7%
Haematuria
7%
Abdominal pain
7%
Arthralgia
7%
Hypothyroidism
6%
Blood creatinine increased
5%
Weight decreased
2%
Sepsis
1%
Pneumonia
1%
Tumour hyperprogression
1%
General physical health deterioration
1%
Death
1%
Acute kidney injury
1%
Pyelonephritis
1%
Device related infection
1%
Urosepsis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab

Trial Design

8Treatment groups
Experimental Treatment
Group I: Cohort 4A: MEDI5395 Dose Level 4 + Sequential DurvalumabExperimental Treatment2 Interventions
Participants will receive IV infusions of MEDI5395 Dose Level 2 on Day 1 and Dose Level 4 on Days 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
Group II: Cohort 3B: MEDI5395 Dose Level 3 + Concurrent DurvalumabExperimental Treatment2 Interventions
Participants will receive IV infusions of MEDI5395 Dose Level 3 on Days 1, 4, 8, 10, 12, and 15 and durvalumab Q4W, starting from the same day as third dose of MEDI5395, for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
Group III: Cohort 3A: MEDI5395 Dose Level 3 + Sequential DurvalumabExperimental Treatment2 Interventions
Participants will receive IV infusions of MEDI5395 Dose Level 3 on Days 1, 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
Group IV: Cohort 3A Backfill: MEDI5395 Dose Level 3 + Sequential DurvalumabExperimental Treatment2 Interventions
Participants will receive IV infusions of MEDI5395 Dose Level 2 on Day 1 and Dose Level 3 on Days 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
Group V: Cohort 2B: MEDI5395 Dose Level 2 + Concurrent DurvalumabExperimental Treatment2 Interventions
Participants will receive IV infusions of MEDI5395 Dose Level 2 on Days 1, 4, 8, 10, 12, and 15 and durvalumab Q4W, starting from the same day as third dose of MEDI5395, for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
Group VI: Cohort 2A: MEDI5395 Dose Level 2 + Sequential DurvalumabExperimental Treatment2 Interventions
Participants will receive IV infusions of MEDI5395 Dose Level 2 on Days 1, 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
Group VII: Cohort 1B: MEDI5395 Dose Level 1 + Concurrent DurvalumabExperimental Treatment2 Interventions
Participants will receive IV infusions of MEDI5395 Dose Level 1 on Days 1, 4, 8, 10, 12, and 15 and durvalumab Q4W, starting from the same day as third dose of MEDI5395, for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
Group VIII: Cohort 1A: MEDI5395 Dose Level 1 + Sequential DurvalumabExperimental Treatment2 Interventions
Participants will receive IV infusions of MEDI5395 Dose Level 1 on Days 1, 4, 8, 10, 12, and 15 followed by durvalumab every 4 weeks (Q4W) starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI5395
2019
Completed Phase 1
~40
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

MedImmune LLCLead Sponsor
347 Previous Clinical Trials
793,870 Total Patients Enrolled
Medimmune LLCStudy DirectorMedImmune LLC
3 Previous Clinical Trials
203 Total Patients Enrolled

Frequently Asked Questions

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

Is eligibility for this trial limited to individuals over 20 years old?

"To participate in this trial, individuals must be between 18 and 101 years of age. An additional 308 trials exist for minors while 2649 studies are open to those over the pensionable age."

Answered by AI

Are there multiple locations offering this clinical trial within Canada?

"Currently, 8 medical centres are welcoming participants into this trial. In addition to La Jolla, Providence and Pittsburgh, there are 5 other sites located around the country. To minimize any potential disruption related to travel costs or inconvenience , it is recommended that you select a clinic in close proximity to your location of residence."

Answered by AI

Has MEDI5395 been validated by the FDA?

"MEDI5395 is still in its early stages of clinical trials and so has a score of 1. Limited data exists that confirms both safety as well as efficacy for this drug."

Answered by AI

How many individuals are receiving therapy in this medical trial?

"At this time, the trial is not actively searching for participants. Initially posted on October 24th 2019 and last updated August 12th 2022, there are currently 2503 studies accepting patients with solid tumors or advanced stages of such cancers as well as 333 specifically studying MEDI5395."

Answered by AI

What ailments can MEDI5395 be utilized to address?

"MEDI5395 is used to manage stage iii non-small cell lung cancer and metastatic urothelial carcinoma in cases that are not amenable to surgery. Additionally, this medication has been approved for the treatment of certain advanced directives."

Answered by AI

Are any volunteers being sought to participate in this trial?

"The clinicaltrials.gov page confirms that, as of 8/12/2022, this research endeavour is not actively recruiting participants - the original post date was 10/24/2019. Fortunately, there are 2836 other studies currently in need of volunteers."

Answered by AI

What prior studies have been conducted using MEDI5395?

"Currently, 333 clinical trials are running related to MEDI5395 of which 52 are at the Phase 3 stage. Majorly based in Cordoba, Texas; 12961 sites offer this treatment experimentally."

Answered by AI

Is it possible to partake in this experiment?

"The current trial is recruiting 39 people with advanced solid tumours, aged between 18 and 101. Eligible applicants must agree to take any necessary steps to prevent the transmission of Newcastle Disease Virus (NDV) from birds or humans; have an ECOG performance status ranging from 0-1; possess histological documentation of their advanced solid tumor; have already gone through one line of treatment for metastatic or recurrent tumors in the past; feature at least 1 measurable lesion in addition to a non-target/non-lymph node that can be biopsied without risk as judged by the investigator. If a suitable non-target lesion"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of MEDI5395 in Combination With Durvalumab in Participants With Select Advanced Solid Tumors
2019. "A Study of MEDI5395 in Combination With Durvalumab in Participants With Select Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03889275.
~7 spots leftby Apr 2025
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