Multi-institutional phase 1 clinical study to examine the safety and tolerability of MU-MA402C for MAGE A4-positive and HLA-A*02:01-positive unresectable advanced or recurrent solid cancer

Phase 1

Recruiting

• Conditions: MAGE A4-positive and HLA-A*02:01-positive unresectable advanced or recurrent solid cancer

• Registration Number: JPRN-jRCT2043210077
• Lead Sponsor: Ishihara Mikiya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1)Solid cancer confirmed histologically or cytologically
2)Unresectable advanced or recurrent disease
3)HLA-A*02:01 positive
4)MAGE A4-expression in tumor by immunohistochemistry
5)Patients who are incurable after at least 1 regimen of standard systemic therapy for advanced or recurrent disease
6)Ability to understand the study content and to give a written consent at free will
7)Legal adult on informed consent
8)ECOG PS: 0-1
9)No severe damage on major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the prescribed lab value criteria
10)Well-managed nutritionally

Exclusion Criteria

1)The following complications are excluded from the study;
unstable angina, cardiac infarction or heart failure, uncontrolled diabetes or hypertension, active infection, obvious interstitial pneumonia or lung fibrosis by chest X-ray, active autoimmune disease requiring steroids or immunosuppressive therapy
2)Serious hypersensitivity
3)Tumor cell invasion into CNS
4)Active multiple cancer
5)Positive for HBs antigen or HBV-DNA observed in serum, or positive for HCV antibody and HCV-RNA observed in serum
6)Positive for antibodies against HIV or HTLV-1
7)LVEF < 50%
8)SpO2 < 94%
9)History of serious hypersensitivity reactions to bovine or murine derived substances
10)History of hypersensitivity reaction to drugs used in this study
11)During chemotherapy or radiotherapy
12)Psycological disorder or drug dependency which may have impact on the consent
13)Patients who cannot agree to practice the adequate birth control
14)Pregnant females, lactating females

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Efficacy (ORR, DCR, best overall response, PFS)