MEDI5752 in Japanese Patients With Advanced Solid Tumors.

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Biological: MEDI5752

Study type: Interventional

Funder types: Industry

Identifiers

NCT05685472

D7980C00006

Details and patient eligibility

About

This is a Phase 1, open-label study evaluate the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor activity of MEDI5752 in Japanese patients with advanced solid solid tumors.

Full description

<Objectives>

Primary Objective:

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

Secondary Objective:

To assess the anti-tumor activity and efficacy of MEDI5752. To describe the pharmacokinetics of MEDI5752.

Exploratory Objective:

To conduct exploratory research into factors that may be predictive of response or may influence the progression of cancer and/or response (efficacy) to MEDI5752.

Eligible patients will be administered as a single dose at each Cycle Day1. Each cycle from Cycle 1 has a duration of 21 days.

A minimum of 3 and a maximum of 9 evaluable patients will be enrolled in each cohort.

Enrollment: 6 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Exclusion Criteria

1. Involvement in the planning and/or conduct of the study (applies to both sponsor 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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

MEDI5752 monotherapy

Experimental group

Treatment:

Biological: MEDI5752