Program Status
Active, not recruitingPhase
Phase 1Prior Immunotherapy Allowed
YesCRC-directed Trial
NoDrugs
Carboplatin, MEDI5752, Pembrolizumab, Pemetrexed, Alimta, Imfinzi, Keytruda, ParaplatinTags
MSI-H/ MMRd, MSS/ MMRpComments
MEDI5752 is a novel, bispecific antibody that is binds CTLA-4 and on programmed cell death 1 (PD-1) expressing T-cells. Prior IO is OK under certain conditions. Arms C and D might have more potential for CRC.
Location | Location Status |
---|---|
United States | |
Research Site Detroit, Michigan 48202 |
Active, not recruiting |
Research Site New York, New York 10065 |
Active, not recruiting |
Research Site Chapel Hill, North Carolina 27599 |
Active, not recruiting |
Research Site Providence, Rhode Island 02903 |
Active, not recruiting |
Research Site Chattanooga, Tennessee 37404 |
Active, not recruiting |
Research Site Nashville, Tennessee 37203 |
Active, not recruiting |
Research Site Fairfax, Virginia 22031 |
Active, not recruiting |
Australia | |
Research Site Melbourne 3000 |
Active, not recruiting |
Research Site Melbourne 3004 |
Active, not recruiting |
Research Site Randwick 2031 |
Active, not recruiting |
France | |
Research Site Bordeaux Cedex 33075 |
Active, not recruiting |
Research Site Lyon 69373 |
Active, not recruiting |
Research Site Villejuif Cedex 94805 |
Active, not recruiting |
Italy | |
Research Site Meldola 47014 |
Active, not recruiting |
Research Site Napoli 80131 |
Active, not recruiting |
Research Site Ravenna 48121 |
Active, not recruiting |
Research Site Roma 168 |
Active, not recruiting |
Korea, Republic of | |
Research Site Cheongju-si 28644 |
Active, not recruiting |
Research Site Gyeonggi-do 13620 |
Active, not recruiting |
Research Site Incheon 21565 |
Active, not recruiting |
Research Site Seoul 03080 |
Active, not recruiting |
Research Site Seoul 03722 |
Active, not recruiting |
Research Site Seoul 05505 |
Active, not recruiting |
Research Site Seoul 06351 |
Active, not recruiting |
Netherlands | |
Research Site Amsterdam 1066 CX |
Active, not recruiting |
Portugal | |
Research Site Lisboa 1649-035 |
Active, not recruiting |
Research Site Porto 4200-072 |
Active, not recruiting |
Spain | |
Research Site A Coruna 15006 |
Active, not recruiting |
Research Site Barcelona 08003 |
Active, not recruiting |
Research Site Barcelona 08028 |
Active, not recruiting |
Research Site Barcelona 08035 |
Active, not recruiting |
Research Site Barcelona 08041 |
Active, not recruiting |
Research Site Barcelona 08916 |
Active, not recruiting |
Research Site Majadahonda 28222 |
Active, not recruiting |
Research Site Malaga 29010 |
Active, not recruiting |
Research Site Pamplona 31008 |
Active, not recruiting |
Research Site Valencia 46010 |
Active, not recruiting |
Taiwan | |
Research Site Taichung 40705 |
Active, not recruiting |
Research Site Tainan 70403 |
Active, not recruiting |
Research Site Taipei 10048 |
Active, not recruiting |
Inclusion Criteria
Inclusion Criteria
1. Age ≥ 18 years at the time of screening
2. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
3. Life expectancy ≥ 12 weeks
4. Histologically or cytologically-confirmed advanced solid tumors
5. 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
6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
7. 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.
8. Subjects must have at least one measurable lesion
9. Adequate organ and marrow function
10. Written informed consent and any locally required authorization
11. Subjects must provide tumor material as applicable
Exclusion Criteria
Exclusion Criteria
1. Involvement in the planning and/or conduct of the study (applies to both MedImmune staff and/or staff at the study site)
2. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
3. For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:
1. 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.
2. Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
3. All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
4. Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.
5. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
6. Active or prior documented autoimmune or inflammatory disorders
7. History of active primary immunodeficiency:
8. History of organ transplant
9. Known allergy or reaction to any component of the planned study treatment.
10. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
11. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria
12. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgery
13. Female subjects who are pregnant or breastfeeding, as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control
14. Uncontrolled intercurrent illness, that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.
15. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study results
16. Judgment by the investigator that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.