A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors

Program Status

Active, not recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Drugs

Carboplatin, MEDI5752, Pembrolizumab, Pemetrexed, Alimta, Imfinzi, Keytruda, Paraplatin

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

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.

NCT ID

NCT03530397

Date Trial Added

2018-05-21

Updated Date

2024-06-24