JPRN-jRCT1080225204CompletedPhase 1
An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-102 in Adult Patients With GPC3-Expressing Previously Treated Solid Tumors
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 11
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
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