CHP-MAGE-A4 cancer vaccine study for refractory MAGE-A4-expressing cancer

CHP-MAGE-A4 cancer vaccine study for refractory MAGE-A4-expressing cancer - CHP-MAGE-A4 cancer vaccine study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002153

Enrollment

Registered

2009-07-02

Start date

2009-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MAGE-A4-expressing refractory cancer patients (non origin-limited) or patients who refuse standard therapy

Interventions

Subcutaneous injection of 100 microgram CHP-MAGE-A4 protein complex vaccine, every two weeks, repeated at least six cycles Subcutaneous injection of 300 microgram CHP-MAGE-A4 protein complex vaccine,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Refractory MAGE-A4-expressing cancer, with clinical stage III or IV, recurrent, metastatic disease, or at high-risk of recurrence 2.Histologically comfirmed malignant tumor 3.MAGE-A4 antigen expressing 4.Performance status (ECOG) 0 to 2 5.Aged twenty or more, male or female 6.At least four-month life expectancy 7.Normal major organ function and meeting the criteria below White cell counts: 2000/uL or more Hemoglobin: 8.0 g/dL or more Platelets: 75000/uL or more Serum bilirubin: within 1.5 times of normal upper level (within 3 times in case of liver metastasis) AST/ALT: within 2.5 times of normal upper level (within 3 times in case of liver metastasis) Serum creatinine: within 1.5 times of normal upper level 8.Not willing to be pregnant (both sexes) 9. Having written informed consent

Exclusion criteria

Exclusion criteria: 1.HIV-positives 2.Double cancers 3.Autoimmune disease 4.History of serious hypersensitivity 5.Active CNS metastasis 6.Lasting less than four weeks from the previous chemotherapy, systemic corticosteroid, immuno-suppresive or stimulating agents, radiotherapy, or operation for primary tumors 7.Pregnant or lactating 8.Inappropriate for study entry judged by an attending physician

Design outcomes

Primary

Measure	Time frame
Safety: maximum tolerated dose, dose-limiting toxicity, profiles of adverse events Efficacy: MAGE-A4-specific immune responses	—

Secondary

Measure	Time frame
Efficacy: tumor responses, progression-free survival, overall survival, response duration time, and time to progression	—

Countries

Japan

Contacts

Public ContactShugo Ueda

Kitano Hospital, The Tazuke Kofukai Medical Research Institute Department of Gastroenterological Surgery and Oncology

shu-ueda@kitano-hp.or.jp06-6312-8831

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026