Clinical study with subsequent subcutaneous administration of GEN0101 in the patients enrolled in the Phase 1 dose-escalation, safety / tolerability and preliminary efficacy study of intratumoral and subcutaneous administration of GEN0101 (GEN0101-JM003).

Clinical study with subsequent subcutaneous administration of GEN0101 in the patients enrolled in the Phase 1 dose-escalation, safety / tolerability and preliminary efficacy study of intratumoral and subcutaneous administration of GEN0101 (GEN0101-JM003). - Clinical study with subsequent administration of GEN0101 after the Phase 1 study of chemotherapy-resistant malignant pleural mesothelioma (MMCT01)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026892

Enrollment

Registered

2017-04-10

Start date

2016-03-03

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

Chemotherapy-resistant Malignant Pleural Mesothelioma

Interventions

GEN0101 will be administered to the patients four times per two weeks subcutaneously, and then washed out for two weeks. This one cycle will be repeated 3 times. GEN0101 will be given at a dose of 60,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients previously participated and completed GEN0101-JM003 clinical trial. 2) Patients providing a written informed consent by voluntary agreement. 3) Age 20 =< and =<90 years old at the time of informed consent 4) SpO2>=93% 5) Expected survival period is more than 12weeks after planned start date of investigational product 6) ECOG Performance Status 0 or 1 7) The marrow function, liver function and the kidney function must be kept as follows clinical tests within 3weeks before planned registration date or at the screening visit. (1) leukocyte >= 3,000/mcL (2) neutrophil >=1,500/mcL (3) platelet >=75,000/mcL (4) hemoglobin >=8.0 g/dL. (5) AST =<100 IU/L (6) ALT =<100 IU/L (7) total bilirubin =<2.5 mg/dL (8) serum creatinine =<2.5 mg/dL

Exclusion criteria

Exclusion criteria: 1) Positive result of the prick test of GEN0101 2) Have serious complications such as uncontrolled active infection 3) Had a history of malignancy other than Malignant Pleural Mesothelioma 4) Have a interstitial pneumonia and pulmonary fibrosis required to treat 6) Have an active autoimmune disease 7) Receiving systemic administration of glucocorticosteroid which restrains immunity response. 8) Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication) 9) PT(%) less than 10% of the lower limit of normal or APTT more than 1.5 times of the upper limit of normal of local reference range at the screening visit 10) Women who is pregnant or lactating, except for the woman who discontinue to lactate (from the day of a written informed consent to the day after 30days of discontinue the administration) In the case of women, to conduct beta-HCG tests to confirm the presence or absence of pregnancy. 11) Inappropriate to be enrolled in this study judged by the investigators

Design outcomes

Primary

Measure	Time frame
Safety/Tolerance	—

Secondary

Measure	Time frame
Tumor marker (SMRP)	—

Countries

Japan

Contacts

Public ContactKazuma Sakura

Osaka University Hospital Medical Center for Translational and Clinical Research

Tg4c_1211@hp-mctr.med.osaka-u.ac.jp06-6210-8289

Outcome results

None listed

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