Share
Save
A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma
The purpose of this study is to evaluate MEDI5752 in combination with Lenvatinib (or Axitinib), in subjects with advanced renal cell carcinoma.
Study details:
The purpose of this Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of MEDI5752 in combination with Lenvatinib (or Axitinib) in subjects with advanced renal cell carcinoma.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2020-08-05
Primary completion: 2027-08-04
Study completion finish: 2027-08-04
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT04522323
Intervention or treatment
BIOLOGICAL: MEDI5752
DRUG: Axitinib
DRUG: Lenvatinib
Conditions
- • Advanced Renal Cell Carcinoma
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Dose Exploration
| BIOLOGICAL: MEDI5752
|
EXPERIMENTAL: Dose Expansion
| BIOLOGICAL: MEDI5752
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of subjects experiencing adverse events (AEs)/serious adverse events (SAEs) | The primary safety endpoint is as assessed by the number of subjects with adverse events and serious adverse events (SAEs) graded per NCI CTCAE v5.0. | Informed consent through 90-Day Post Last Dose. |
Number of Participants With Dose Limiting Toxicities (DLT) of MEDI5752 and Lenvatinib (or Axitinib) during the Dose Exploration period. | Determine the MTD and recommended Phase 2 dose (RP2D) of the combination of MEDI5752 and Lenvatinib. A dose limiting toxicity (DLT) is defined as MEDI5752 treatment-related AE of any Grade 3 or higher toxicity (as defined in the protocol) CTCAE v5.0. | Informed consent through the first 21 days of treatment with MEDI5752 and Lenvatinib (or Axitinib) in the Dose Exploration Period. |
Number of subjects experiencing adverse events (AEs) leading to discontinuation. | The primary safety endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0. | Informed consent through 90-Day Post Last Dose. |
Number of subjects experiencing abnormal laboratory evaluations. | The primary safety endpoint is as assessed by the number of subjects experiencing changes in laboratory evaluations from baseline. | Informed Consent through 90 post treatment date. |
Number of subjects experiencing changes in vital signs reported as Adverse Events. | The primary safety endpoint is assessed by the change in vital signs from baseline. | Informed consent through 90-Day Post Last Dose |
Number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events. | The primary safety endpoint is as assessed by the change in ECG parameters from baseline. | Informed consent through 90-Day Post Last Dose |
Preliminary antitumor activity of MEDI5752 combined with Lenvatinib (or Axitinib) by Objective response rate per RECIST version (v) 1.1. | The primary efficacy endpoint is assessed by the antitumor activity of MEDI5752 combined with Lenvatinib. | First subject enrolled through 18 months from last subject enrolled, an average of 30 months. |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the progression free survival (PFS) according to RECIST v1.1. | The endpoint for assessment of PFS is defined as the time from the first dose of treatment until the documentation of PD or death due to any cause, whichever occurs first. | Last Subject Enrolled through study completion, an average of 48 months. |
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Best Overall Response (BOR) according to RECIST v1.1. | The endpoint for assessment of BOR will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer treatment | First subject enrolled through 18 months from last subject enrolled, an average of 30 months. |
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Disease Control Rate (DCR). | The endpoint for assessment of DCR is measured by the proportion of subjects with a BOR of confirmed CR, PR, or SD. | 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 Duration of Response (DOR) according to RECIST v1.1. | The endpoint for assessment of DOR is measured by the duration from the first documented OR to the first documented PD or death due to any cause, whichever occurs first. | 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 Time to Response (TTR) according to RECIST v1.1. | The endpoint for assessment of TTR is defined as the time from the first dose of treatment until the first documentation of an OR. | 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 |
Pharmacokinetics of MEDI5752: Cmax | The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. | Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle |
Pharmacokinetics of MEDI5752: AUC | The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. | Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle |
Pharmacokinetics of MEDI5752: Cmin | The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. | Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle |
Pharmacokinetics of MEDI5752: t 1/2 | The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. | Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle |
Pharmacokinetics of MEDI5752: Clearance | The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. | Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle |
Immunogencity of MEDI572: Incidence of ADAs against MEDI5752 | The endpoints for the immunogenicity of MEDI5752 include the number of subjects who develop detectable anti-drug antibodies (ADAs) to MEDI5752. | Day 1, 8, 15, 22, 30, 64 and then Day 1 of every other cycle |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!