FUTIBATINIB for Advanced solid tumour | Malignant solid tumor

Inclusion criteria

• {"criterion_text":"- Part A: Subjects must have histologically or cytologically confirmed malignancy that is metastatic or unresectable, who have progressed to standard therapy, who are receiving a standard anticancer treatment but no subsequent approved treatment would be available upon progression, who are unable to receive standard therapy, or for whom standard therapy does not exist.\n- Ability to understand and the willingness to sign a written informed consent document.\n- Part B: Inclusion criterion 2/3/4/6/8/9/10/12 from part A. Subjects must have metastatic or unresectable malignant tumour, histologically or cytological confirmed and progressing to current therapy. Tumours must be refractory to standard therapy or tumours for which standard therapy does not exist, or subjects may be unable to receive standard therapy.\n- Subjects must have adequate renal and hepatic function as described in the module protocol: • Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: (140 − age) × (weight in kg) × (0.85 if female)/72 × (serum creatinine in mg/dL) • Serum bilirubin ≤ 1.5 × ULN; with the following exception: subjects with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled • AST, ALT, and alkaline phosphatase < 2.5 x ULN, with the following exceptions: o Patients with documented liver metastases: AST and ALT < 5 x ULN o Patients with documented liver or bone metastases: alkaline phosphatase < 5 x ULN\n- Subjects receiving therapeutic anticoagulation (such as low−molecular weight heparin or warfarin) should be on a stable dose\n- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from donating eggs, as described in the module protocol.\n- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined in the protocol. (Please refer to section 3.1 Inclusion Criteria of iProfiler, Module 1, 2 & 3 for full list)\n- Subjects must have ECOG performance status of 0 or 1.\n- Subjects must be 18 year-old or older.\n- Subjects must have measurable disease according to RECIST 1.1. (for M1: Subjects with non-prostate solid tumours must have measurable disease according to RECIST 1.1 and patients with prostate cancer must have a tumour amenable to assess biochemical and/or objective radiographic responses according to PCWG3 and RECIST 1.1.)\n- Subjects must have enough tumour tissue for molecular analysis • Subjects providing formalin-fixed paraffin embedded tissue (FFPE) must provide a minimum amount of tissue ranging from 20 to 28 slides depending on the sample tumour cellularity. If there is not enough archival tissue to meet this criterion, the subject must undergo a tumour biopsy. • Subjects providing fresh frozen tissue (FFT) must provide 4 core biopsies or equivalent. FFT must be preferentially collected from a tumour biopsy; hence, patients must have disease amenable to be biopsied. Otherwise, the subject should have FFT stored in a biobank or biorepository. • Efforts will be made to provide FFT in at least one quarter of the participating subjects. The proportion of subjects that might provide FFT might change based on the results from the molecular analysis. • Since some of the tests are performed in FFPE tissue, patients providing FFT from a recent biopsy will have part of the sample processed in FFPE tissue as per Laboratory manual.\n- Subjects must have adequate hematological function: absolute granulocyte count ≥ 1.5 × 10 9/L, platelet count ≥ 100 × 10 9/L.\n- Subject must have adequate renal and hepatic function: Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 30ml/min, serum bilirubin ≤ 1.5 × ULN; unless due to Gilbert's syndrome, AST/ALT ≤ 5 × ULN if liver metastases are present or AST/ALT ≤ 3 × ULN if the subject has no liver involvement.\n- For subjects requiring a tumour biopsy: patients must have adequate coagulation function quick time ≥ 60% or INR ≤ 1.5\n- Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumour"}

Exclusion criteria

• {"criterion_text":"- Part A Subjects with leptomeningeal disease should be excluded from this clinical trial.\n- Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study.\n- Treatment with an investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product, whichever is longer), with the exception of monoclonal antibodies. Based on the half-life of monoclonal antibodies and the limited overlap on toxicities, a 4 week wash-out period will be allowed.\n- Subjects with known unstable brain metastases should be excluded from this clinical trial. •Exception: Subjects with treated brain metastasis which remain stable or responding 6 weeks after completing radiotherapy can be included.\n- Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, active bleeding diathesis, impaired oxygenation requiring continuous oxygen supplementation, ophthalmologic condition that is clinically unstable, active infection, cardiovascular disease, or psychiatric illness/social situations that would limit compliance with study requirements.\n- Subjects with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. •Subjects with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. •Subjects positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to Cycle 1, Day 1, unstable arrhythmias or unstable angina.\n- Another primary malignancy other than disease under study within 2 years prior to Cycle 1 Day 1, unless consider at low risk of relapse at Investigator discretion.\n- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, fusion proteins or any excipient of the experimental product.\n- Prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n- Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. • Influenza vaccination can be given during influenza season only (example: approximately October to March in the Northern Hemisphere), but subjects must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1 or at any time during the study.\n- Subjects with known unstable brain metastases should be excluded from this clinical trial. •Exception: Subjects who have undergone surgery and/or radiotherapy and in which brain metastases remain stable or decrease in size for six months after having completed therapy.\n- History of active tuberculosis\n- Contraindications included in the product information of the drugs used in the study. Please refer to section 3.2 Exclusion Criteria for full list of iProfiler and module protocol.\n- Subjects with spinal cord compression not definitively treated with surgery and/or radiation.\n- Subjects with uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, LVEF <50%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n- Subjects with inability to swallow tablets or capsules.\n- Subjects with known HIV, hepatitis B or hepatitis C infection.\n- Subjects with known history of malabsorption.\n- Part B: Pregnant or breastfeeding women. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to Day 1. This negative test will be valid for Cycle 1 day 1. In subsequent cycles, serum pregnancy test will be performed on day 1 of each cycle, with a +/- 3 day window, and prior to drug administration.\n- Any approved anticancer therapy, including chemotherapy, hormonal therapy or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed: •Hormone-replacement therapy or oral contraceptives. •Somatostatin analogues for the treatment of symptoms related with neuroendocrine tumours. •Gonadotropin-releasing hormone agonists or antiandrogens for prostate cancer. •Palliative radiotherapy for bone metastases > 2 weeks prior to Cycle 1, Day 1."}

Primary endpoints

• {"endpoint_text":"- Module 1, 2 & 3: • Overall response rate (ORR) or complete response (CR) by RECIST 1.1 of different targeted agents in molecularly selected small patient populations. Specific to Module 1: * For patients with prostate cancer in arm 1G: ORR at 12 weeks ofatezolizumab by a composite of biochemical and/or objective radiographic responses according to Prostate Cancer Working Group 3 (PCWG3) and RECIST 1.1. No specific primary endpoint in iProfiler (Part A) protocol.","definition_or_measurement_approach":"Measured as Overall Response Rate (ORR) or Complete Response (CR) assessed by RECIST 1.1 across modules; for Module 1 prostate cancer arm 1G ORR at 12 weeks of atezolizumab defined by a composite of biochemical and/or objective radiographic responses according to PCWG3 and RECIST 1.1."}

France

Earliest CTIS Part Ii Submission Date

05-09-2024

Latest Decision Or Authorization Date

17-04-2026

Processing Time Days

589

Number Of Sites

1

Number Of Participants

45

Italy

Earliest CTIS Part Ii Submission Date

05-09-2024

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

587

Number Of Sites

1

Number Of Participants

12

Spain

Earliest CTIS Part Ii Submission Date

05-09-2024

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

592

Number Of Sites

1

Number Of Participants

63

Germany

Earliest CTIS Part Ii Submission Date

05-09-2024

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

586

Number Of Sites

2

Number Of Participants

10

Sweden

Earliest CTIS Part Ii Submission Date

05-09-2024

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

587

Number Of Sites

1

Number Of Participants

11

Netherlands

Earliest CTIS Part Ii Submission Date

05-09-2024

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

588

Number Of Sites

1

Number Of Participants

26

Primary sponsor

Full Name

Vall D Hebron Institute Of Oncology

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Contract research organisations

Name

IQVIA Limited

Responsibilities

codes: 1,8

Third parties

• {"country":"Netherlands","full_name":"Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting","duties_or_roles":"codes: 1,6,7","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts","duties_or_roles":"codes: 1,15; Sample Process Lab, Translational Oncology: whole-exome sequencing (WES), RNAseq","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"code: 15; Supply trial medication","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Cambridge University Hospitals NHS Foundation Trust","duties_or_roles":"code: 10","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"code: 15; FMI panel","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Fondazione IRCCS Istituto Nazionale Dei Tumori","duties_or_roles":"codes: 1,15; Immunobiology of human tumors lab: miRNA signature, myeloid cell profiling, DSP-Nanostring","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Sweden","full_name":"Karolinska Institutet","duties_or_roles":"codes: 1,15; Science for Life Laboratory, Cancer Proteomics Mass Spectrometry: proteomics and cytokine profiling","organisation_type":"Educational Institution"}
• {"country":"France","full_name":"Institut Gustave Roussy","duties_or_roles":"codes: 1,15; Stool microbiome","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United Kingdom","full_name":"University Of Cambridge","duties_or_roles":"codes: 1,15; Molecular Cancer Diagnostics Lab - NGS panel, germline DNA analyses, ctDNA, single-cell RNAseq, digital pathology","organisation_type":"Educational Institution"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes: 1,8","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Vall D Hebron Institute Of Oncology","duties_or_roles":"codes: 1,11,15; Cancer Genomics Lab: NGS panel, RNAseq and tissue QC","organisation_type":"Laboratory/Research/Testing facility"}