A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Japanese Subjects with Advanced Solid Tumors

JRCT ID: jRCT2031220470

Registered date:28/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Advanced Solid Tumors
• Date of first enrollment: 28/11/2022
• Target sample size: 18
• Study type: Interventional
• Intervention(s): MEDI5752 administration

Outcome(s)

• Primary Outcome: To evaluate the safety and tolerability of MEDI5752 in Japanese subjects with advanced solid tumors.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Age or more 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 is 12 weeks or more.

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 where locally available from Day 1 and for 90 days after the final dose of investigational product.

8. Subjects must have at least one measurable lesion

9. Adequate organ and marrow function

10. Signed and dated written informed consent

11. Subjects must provide tumor material as applicable

Exclude 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:

a. 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.

b.Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.

c.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 organ transplant

8. Known allergy or reaction to any component of the planned study treatment.

9. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression

10. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria

11. 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

12. 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

13. 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.

14. 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

15. 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.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT05685472