Study Summary
This trial will test a new drug, MEDI5752, in combination with Lenvatinib or Axitinib, to see if it is effective in treating advanced renal cell carcinoma.
Eligible Conditions
- Kidney Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
7 Primary · 11 Secondary · Reporting Duration: Informed Consent 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
Day 1
Immunogencity of MEDI572: Incidence of ADAs against MEDI5752
Day 1
Pharmacokinetics of MEDI5752: AUC
Pharmacokinetics of MEDI5752: Clearance
Pharmacokinetics of MEDI5752: Cmax
Pharmacokinetics of MEDI5752: Cmin
Pharmacokinetics of MEDI5752: t 1/2
Month 30
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Best Overall Response (BOR) according to RECIST v1.1.
Preliminary antitumor activity of MEDI5752 combined with Lenvatinib (or Axitinib) by Objective response rate per RECIST version (v) 1.1.
Informed Consent through 90 post treatment date.
Number of subjects experiencing abnormal laboratory evaluations.
Informed Consent 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
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Disease Control Rate (DCR).
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Duration of Response (DOR) according to RECIST v1.1.
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Time to Response (TTR) according to RECIST v1.1.
Informed consent through 90-Day Post Last Dose
Number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events.
Number of subjects experiencing changes in vital signs reported as Adverse Events.
Informed consent through 90-Day Post Last Dose.
Number of subjects experiencing adverse events (AEs) leading to discontinuation.
Number of subjects experiencing adverse events (AEs)/serious adverse events (SAEs)
Day 21
Number of Participants With Dose Limiting Toxicities (DLT) of MEDI5752 and Lenvatinib (or Axitinib) during the Dose Exploration period.
Month 48
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the progression free survival (PFS) according to RECIST v1.1.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Dose Expansion
1 of 2
Dose Exploration
1 of 2
Experimental Treatment
70 Total Participants · 2 Treatment Groups
Primary Treatment: MEDI5752 · No Placebo Group · Phase 1
Dose ExpansionExperimental Group · 3 Interventions: Lenvatinib, Axitinib, MEDI5752 · Intervention Types: Drug, Drug, Biological
Dose ExplorationExperimental Group · 3 Interventions: Lenvatinib, Axitinib, MEDI5752 · Intervention Types: Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved
Axitinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: informed consent 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
Who is running the clinical trial?
MedImmune LLCLead Sponsor
347 Previous Clinical Trials
793,727 Total Patients Enrolled
AstraZeneca Early OncologyStudy DirectorAstraZeneca
Eligibility Criteria
Age 18 - 101 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be at least 18 years old to be screened.
The body weight must be more than 35 kg.
There is a high incidence of advanced renal cell carcinoma (RCC) with a clear cell component.
This means that the advanced RCC had not been treated before in that setting.
is required
A tissue sample is required in order to provide tumor material
Subjects must have at least one measurable lesion according to the RECIST v1.1 guidelines.
This means that a person's life expectancy is at least 12 weeks long.
The text discusses the need for adequate organ and marrow function for a healthy individual
You have no signs or symptoms of cancer.
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Conditions
Cancer Related
Treatments