A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (NCT03530397) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors
United States401 participantsStarted 2018-04-24
Plain-language summary
The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.
Who can participate
Age range18 Years – 120 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years at the time of screening
✓. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
✓. Life expectancy ≥ 12 weeks
✓. Histologically or cytologically-confirmed advanced solid tumors
✓. Subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicable
✓. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
✓. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom with spermicide where locally available from Day 1 and for 90 days after the final dose of investigational product. Males receiving pemetrexed or carboplatin must use contraception during study treatment and up to 6 months thereafter.
✓. Subjects must have at least one measurable lesion
Exclusion criteria
✕. Involvement in the planning and/or conduct of the study (applies to both MedImmune staff and/or staff at the study site)
✕. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
What they're measuring
1
The number of subjects experiencing treatment related adverse events (AEs) (Dose-escalation phase)
Timeframe: From the time of informed consent through 114 days following termination of treatment with investigational product
2
Preliminary anti-tumor activitiy of MEDI5752 (versus pembrolizumab, where applicable) using Objective Response based on RECIST v1.1 (Dose-expansion phase)
Timeframe: 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
3
The number of subjects experiencing dose-limiting toxicities (DLTs) (Dose-escalation phase)
Timeframe: Up to 21 days following the first dose
4
The number of subjects experiencing abnormal laboratory evaluations (Dose-escalation phase)
Timeframe: From the time of informed consent through 114 days following termination of treatment with investigational product
5
The number of subjects experiencing changes from baseline in vital signs reported as adverse events (Dose-escalation phase)
Timeframe: From the time of informed consent through 114 days following termination of treatment with investigational product
6
The number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events (Dose-escalation phase)
Timeframe: From the time of informed consent through 114 days following termination of treatment with investigational product
. For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:
✕. Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 21 days of commencing treatment with investigational product.
✕. Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
✕. All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
✕. Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.
✕. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
7
The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-escalation phase)
Timeframe: From the time of informed consent through 114 days following termination of treatment with investigational product