A Study of TAK-102 in Adult with Previously-Treated Solid Tumors
- Conditions
- Solid Tumors
- Registration Number
- JPRN-jRCT1080225204
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 11
1. Male or female participants aged >=18 years at the time of signing informed consent.
2. Participants must have a diagnosis of solid tumors.
3. Participants with solid tumor who are refractory or intolerant to standard treatments.
4. GPC3-expression must be determined on the tumor locally by IHC using a validated assay, scoring and staining confirmed by the sponsor prior to leukapheresis procedures.
5. Life expectancy >=12 weeks.
6. ECOG performance status of 0 or 1.
7. Adequate organ function as confirmed by clinical laboratory values as specified below:
a. Total bilirubin must be <1.5 x the upper limit of the normal range (ULN). Total bilirubin may be elevated up to 3 x ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in the liver.
b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be <3 x ULN. AST and ALT may be elevated up to 5 x ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in liver.
c. Calculated creatinine clearance >50 mL/mins (The Cockcroft-Gault formula).
d. Hemoglobin must be >=8 g/dL.
e. Neutrophil count must be >1000/mm^3.
f. Absolute lymphocyte count must be >500/mm^3.
g. Platelet count must be >75,000/mm^3.
h. Prothrombin time-international normalized ratio must be =<1.7.
i. Activated partial thromboplastin time (APTT) must be =<1.5 x ULN.
8. Participants must have radiographically measurable disease as defined by RECIST 1.1.
9. Female participants who:
a. Are postmenopausal (natural amenorrhea and not due to other medical reasons) for at least 1 year before the screening visit, OR
b. Are surgically sterile, OR
c. If they are of childbearing potential, agree to practice 1 highly effective nonhormonal method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through at least 12 months following TAK-102 infusion, OR
d. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant.
Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.
10. Male participants, even if surgically sterilized (ie, postvasectomy), who:
a. Agree to practice effective barrier contraception from the time of signing the informed consent through at least 12 months following TAK-102 infusion, OR
b. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant.
Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.
11. Voluntary written consent must be given before performance of any study-related procedures not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
12. Willingness and ability to comply with scheduled visits and study procedures.
1. Active systemic infections excluding well-controlled chronic HBV/HCV infections, coagulation disorders, or other major medical illnesses including cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, and obstructive/restrictive pulmonary disease.
2. Participants with known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure. A well-controlled atrial fibrillation would not be an exclusion whereas uncontrolled atrial fibrillation would be an exclusion.
3. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
4. Patients with any signs of lymphoma and/or leukemia
5. Patients who are diagnosed with or treated for another malignancy within 3 years before leukapheresis procedures. Patients with nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) would be included if they were adequately treated.
6. Active, serious infection requiring antibiotics.
7. Any disease requiring systemic steroid treatment or steroid inhalant.
8. Any prior use of cell and gene therapy(ies).
9. Treatment with any investigational products (except for cell or gene therapy) within 14 days before leukapheresis procedures or 28 days before treatment with preconditioning chemotherapy/TAK-102.
10. Systemic anticancer therapy (including platinum-based chemotherapies and I/O therapies) within 14 days before leukapheresis procedures or treatment with preconditioning chemotherapy/TAK-102.
11. Treatment with radiotherapy within 14 days before leukapheresis procedures or treatment with preconditioning chemotherapy/TAK-102.
12. Treatment with major surgery within 28 days before leukapheresis procedures or treatment with preconditioning chemotherapy/TAK-102 (minor surgical procedures such as catheter placement are not exclusionary criteria).
13. Previous treatment with any GPC3-targeted therapy.
14. Any unresolved toxicity greater than Grade 2 from previous anticancer therapy.
15. Participants with risk of bleeding as judged by the investigator(s).
16. Presence of central nervous system (CNS) metastasis or other significant neurological conditions (participant with CNS metastases that have been effectively treated where necessary and stable can be enrolled).
17. Participants with medically diagnosed past or current hepatic encephalopathy.
18. Participants with positive human immunodeficiency virus (HIV) and/or human T-cell lymphotrophic virus (HTLV) infection.
19. Participants with clinically significant ascites, which is defined as ascites that are physically positive or require intervention (eg, puncture or medication) for control; those whose imaging result shows ascites requiring no intervention may be included.
20. Participants with a history of organ transplantation or awaiting organ transplantation.
21. Participants with severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, ganciclovir, or streptomycin.
22. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.
23. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test (urine pregnancy test is allowed before treatment with preconditioning chemotherapy and TAK-102).
Note: Female participants who are lactating will be eligible if they discontinue breastfeeding before the treatment with TAK-102.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method