A Study of TAK-102 in Adult With Previously-Treated Solid Tumors

NCT04405778 | Terminated Phase 1

• 3 other identifiers: TAK-102-1501U1111-1247-6429jRCT1080225204
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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 working. It is hoped that TAK-102 will eventually treat people with solid tumors with the GPC3 protein. TAK-102 will be added to each person's white blood cells so is custom-made for each person. In this study, people with solid tumors with GPC3 will receive TAK-102 with their white blood cells. The main aims of this study are to check if the participants get any side effects from treatment with TAK-102 and to check how much TAK-102 they can receive without getting side effects from it. Researchers can then work out the best dose of TAK-102 to give to participants in future studies. At the first visit, the study doctor will check who can take part. For those who can take part, the study doctors will collect white blood cells from each participant. These cells are sent to the laboratory where TAK-102 is added to each participant's cells. This can take up to 4 weeks. Participants will receive specific treatments while they are waiting for TAK-102. Then, participants will receive TAK-102 with their cells slowly through a vein (infusion). 3 different small groups of participants will receive lower to higher doses of TAK-102. Each participant will just receive 1 dose. The study doctors will check for side effects after each different dose of TAK 102. In this way, researchers can work out the best dose of TAK-102 to give to participants in future studies. Participants will stay in hospital for 28 days or longer for their treatment. Then, they will visit the clinic for regular check-ups for up to 36 months.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Number of Participants with First Cycle Dose-Limiting Toxicities (DLTs)

  Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.

  Up to 28 days

• Number of Participants With One or More Treatment-emergent Adverse Event (TEAE)

  An adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.

  Up to 3 year

• Number of Participants With Adverse Events of Clinical Interest

  Adverse events of clinical interest include severe immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS), hemophagocytic lymphohistiocytosis (HLH), macrophage activation syndrome (MAS), tumor lysis syndrome (TLS), and liver function abnormality.

  Up to 3 year

Secondary Outcomes (12)

• Objective response based on the investigator's assessment using study-specific modified Response Evaluation Criteria in Solid Tumors Version 1.1 (ssmRECIST 1.1)

  Up to 3 year

• Duration of Response (DOR) as Assessed by the Investigator

  Up to 3 year

• Disease Control Rate (DCR) as Assessed by the Investigator

  Up to 3 year

• Time to Progression as Assessed by the Investigator

  Up to 3 year

• Progression-Free Survival (PFS) as Assessed by the Investigator

  Up to 3 year

Study Arms (3)

TAK-102 Cohort 1

EXPERIMENTAL

TAK-102, 1 × 10\^7 Chimeric antigen receptor (CAR) (+) cells/body as a starting dose, intravenous infusion, will be administered at approximately 5 mL/min and completed within 60 minutes.

Biological: TAK-102

TAK-102 Cohort 2

EXPERIMENTAL

TAK-102, 1 × 10\^8 CAR (+) cells/body as a starting dose, intravenous infusion, will be administered at approximately 5 mL/min and completed within 60 minutes.

Biological: TAK-102

TAK-102 Cohort 3

EXPERIMENTAL

TAK-102, 1 × 10\^9 CAR (+) cells/body as a starting dose, intravenous infusion, will be administered at approximately 5 mL/min and completed within 60 minutes.

Biological: TAK-102

Interventions

TAK-102 BIOLOGICAL

TAK-102 intravenous infusion

TAK-102 Cohort 1; TAK-102 Cohort 2; TAK-102 Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (3)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Location

Kyoto University Hospital

Kyoto, Japan

Location

Related Links

• To obtain more information on the study, click here/on this link

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 28, 2020
• Study Start: July 10, 2020
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)