TAPISTRY (BO41932)
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Titel in German |
Plattform-Studie mit Präzisions-Immunoonkologie bei fortgeschrittenen, inoperablen oder metastasierten soliden Tumoren |
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Titel in English |
TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL |
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Description |
The goal of this study is to examine the effects, good or bad, of targeted therapies (drugs that identify and attack specific types of cancer cells) or immunotherapy (drugs that help the body's immune system fight cancer cells) in patients with solid cancer Tumors with specific genetic changes or with a high number of mutations. Patients are divided into cohorts (groups) depending on whether they have a specific type of genetic change or a high number of mutations in their tumor. Number of mutations in your tumor. Cohort A: Entrectinib in patients with ROS1 fusion-positive tumors ∙ Group Cohort B: Entrectinib in patients with NTRK1/2/3 fusion-positive tumors ∙ Cohort C: Alectinib in patients with ALK fusion-positive tumors Cohort D: Atezolizumab in patients with tumor mutation burden (TMB)-high tumors Cohort E: Ipatasertib in patients with AKT1/2/3 mutation-positive tumors Cohort F: Trastuzumab emtansine in patients with HER2 mutation-positive tumors Cohort G: Idasanutlin in patients with MDM2-amplified, TP53 wild-type tumors (group closed due to recruitment cancellation) Cohort H: GDC-0077 in patients with PIK3CA multimutant-positive tumors. |
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Phase/Biobank/ect. |
Phase 2 |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
open since 28.10.2021 (only cohorts A, B, C, K, L, M, N) |
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BASEC Nummer |
2021-00425 |
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KOFAM |
SNCTP000004623 |
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Insel-Nummer |
4921 |
Amgen 20210023
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Title in German |
Eine Phase-1/1b/2-Studie zur Bewertung der Sicherheit, Verträglichkeit, Pharmakokinetik, Pharmakodynamik und Wirksamkeit von AMG 193 allein und in Kombination mit Docetaxel bei Patienten mit fortgeschrittenen soliden Methylthioadenosinphosphorylase (MTAP)-null-Tumoren |
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Title in English |
A phase 1/1b/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors |
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Description |
This project is being conducted to determine the effectiveness (how well something works), tolerability (how the study drug feels) and safety of the tested preparation/medicine AMG 193 alone and in combination with docetaxel for the treatment of advanced solid tumors with MTAP loss testing. The study will enroll patients who have advanced cancer that has a DNA change, either loss of methylthioadenosine phosphorylase (MTAP) or loss of cyclin-dependent kinase inhibitor 2A (CDKN2A), which affects the functioning of the protein enzyme. Arginine methyltransferase 5 (PRMT5) in your cancer may be restricted. Protein arginine methyltransferase 5 is important for cancer cell survival, and AMG 193 is a PRTM5 inhibitor that can work with the DNA change in your cancer cells to further inhibit PRMT5, killing the cancer. In the laboratory, AMG 193 inhibits PRMT5 activity in cancer cells with MTAP loss and specifically kills them. |
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Phase |
1/1b/2 |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Study Nurse (Trainee) |
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Status |
open for patient recruitment: 20.10.2022 |
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BASEC Nummer |
2021-02428 |
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KOFAM |
SNCTP000004972 |
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EudraCT No. |
EUCTR2021-004764-10 |
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Insel-Nummer |
5157 |
Incyte-INCB123667-101
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Title in German |
Eine Studie zur Beurteilung der der Wirkung und Sicherheit des neuen Medikaments INCB123667 bei Krebspatienten. |
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Title in English |
A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors |
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Description |
This is a first-in-human (Phase I) study being conducted to find out how an investigational new medicine works in a small number of participants with cancer. This helps researchers understand what happens to the study drug in the body and whether side effects (unwanted medical problems) occur. Part 1 of the study will enroll participants who have cancer, a disease in which abnormal cells divide uncontrollably and can spread to other parts of the body. Participants in this study will: Have cancer that has worsened during or after receiving previous standard treatment Have they not tolerated or been unable to receive standard treatment(s)? Are patients for whom no treatment is available that could improve their condition? In addition, the second part of the study will only include participants who have a gene called "CCNE1" in some cancers of the ovaries, uterus, stomach, esophagus, breast and the tissue that lines the abdominal wall and most organs in the abdomen covered (also known as the peritoneum). |
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Phase |
1 |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Back-up |
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Status |
open for patient recruitment since 01.02.2023 |
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BASEC Nummer |
2022-00772 |
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KOFAM |
SNCTP000005191 |
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WHO-Register-Nummer |
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Insel-Nummer |
5159 |
Philogen IL 12L 19L 19-01 DODEKA
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Title in German |
Eine Phase I Studie zur Beurteilung der Sicherheit und frühen Anzeichen der Wirksamkeit des humanen monoklonalen Antikörper-Zytokin Fusionsproteins IL12-L19L19 |
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Title in English |
A phase I study to evaluate safety and early signs of efficacy of the human monoclonal antibody-cytokine fusion protein IL12-L19L19 |
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Description |
We are interested in determining whether the investigational drug IL12-L19L19 is tolerated by patients suffering from certain types of advanced/metastatic solid tumors and whether early signs of efficacy can be observed. The active principle of the investigational drug is IL12-L19L19. IL12-L19L19 is a protein composed of two components, the L19 antibody and the anticancer drug IL12. It has the following properties: IL12 is the abbreviation for the cytokine “Interleukin 12”. IL12 stimulates cell-mediated immune defense and therefore has some anticancer activity. L19 is an antibody that selectively binds to a region of the protein fibronectin called “extradomain B” (EDB). EDB is only present in newly formed blood vessels and is therefore present in large quantities in most solid tumors. The property of L19 to accumulate exclusively in tumors has been described in the specialist literature and has been demonstrated using various methods such as histological analyses, animal experiments and clinical studies. The investigational drug in this study, IL12-L19L19, consists of IL12, which is coupled to part of the L19 antibody so that the drug accumulates exclusively in tumors. We assume that a prolonged anticancer effect and an increased concentration of IL12 directly in the tumor can be achieved along with fewer and weaker side effects. In this clinical study, the investigational drug is being tested on humans for the first time and the safety and tolerability of the drug are being investigated. Patients suffering from advanced/metastatic solid tumors and whose disease has progressed following therapy with immune checkpoint inhibitors can take part in this clinical study. It is a requirement that you have received immune checkpoint inhibitor treatment before this study and that the cancer has responded. All patients must be between 18 and 80 years old. Previous therapies may include chemotherapy, immunotherapy, or radiation therapy, but these therapies must be completed at least 4 weeks before the first administration of the investigational drug. Patients with primary brain tumors are not allowed to participate. |
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Phase |
1 |
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Head Clinical Trial |
Dr. S. Schmid |
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Study Nurse |
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Status |
temporarily closed for patient recruitment: since April 2024 |
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BASEC-Nummer |
2020-00433 |
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WHO-Register-Nummer |
2019-000613-36 |
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Insel-Nummer |
5576 |