Status:
TERMINATED
A Study of TAK-102 in Adult With Previously-Treated Solid Tumors
Lead Sponsor:
Takeda
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Some solid tumors make a lot of a protein called glypican 3(GPC3), which helps it to grow. Healthy cells and tissues do not make GPC3. TAK-102 is a medicine that sticks to GCP3 and stops it from worki...
Detailed Description
The drug being tested in this study is called TAK-102. TAK-102 is being tested to treat people who have GPC3-expressing previously treated solid tumors. This study will look at the safety and tolerabi...
Eligibility Criteria
Inclusion
- Male or female participants aged ≥18 years at the time of signing informed consent.
- Participants must have a diagnosis of solid tumors.
- Participants with solid tumor who are refractory or intolerant to standard treatments.
- 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.
- Life expectancy ≥12 weeks.
- ECOG performance status of 0 or 1.
- Adequate organ function as confirmed by clinical laboratory values as specified below:
- Total bilirubin must be \<1.5 × the upper limit of the normal range (ULN). Total bilirubin may be elevated up to 3 × ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in the liver.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be \<3 × ULN. AST and ALT may be elevated up to 5 × ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in liver.
- Calculated creatinine clearance \>50 mL/mins (The Cockcroft-Gault formula).
- Hemoglobin must be ≥8 g/dL.
- Neutrophil count must be \>1000/mm\^3.
- Absolute lymphocyte count must be \>500/mm\^3.
- Platelet count must be \>75,000/mm\^3.
- Prothrombin time-international normalized ratio must be ≤1.7.
- Activated partial thromboplastin time (APTT) must be ≤1.5 × ULN.
- Participants must have radiographically measurable disease as defined by RECIST 1.1.
- Female participants who:
- Are postmenopausal (natural amenorrhea and not due to other medical reasons) for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- 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
- 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.
- Male participants, even if surgically sterilized (ie, postvasectomy), who:
- Agree to practice effective barrier contraception from the time of signing the informed consent through at least 12 months following TAK-102 infusion, OR
- 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.
- 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.
- Willingness and ability to comply with scheduled visits and study procedures.
Exclusion
- 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.
- 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.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Patients with any signs of lymphoma and/or leukemia
- 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.
- Active, serious infection requiring antibiotics.
- Any disease requiring systemic steroid treatment or steroid inhalant.
- Any prior use of cell and gene therapy(ies).
- 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.
- Systemic anticancer therapy (including platinum-based chemotherapies and I/O therapies) within 14 days before leukapheresis procedures or treatment with preconditioning chemotherapy/TAK-102.
- Treatment with radiotherapy within 14 days before leukapheresis procedures or treatment with preconditioning chemotherapy/TAK-102.
- 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).
- Previous treatment with any GPC3-targeted therapy.
- Any unresolved toxicity greater than Grade 2 from previous anticancer therapy.
- Participants with risk of bleeding as judged by the investigator(s).
- 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).
- Participants with medically diagnosed past or current hepatic encephalopathy.
- Participants with positive human immunodeficiency virus (HIV) and/or human T-cell lymphotrophic virus (HTLV) infection.
- 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.
- Participants with a history of organ transplantation or awaiting organ transplantation.
- Participants with severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, ganciclovir, or streptomycin.
- Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.
- 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.
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04405778
Start Date
July 10 2020
End Date
May 9 2025
Last Update
May 29 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
2
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
3
Kyoto University Hospital
Kyoto, Japan