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 |
SwissNOS GluGlio
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Title in German |
GLUTAMAT SIGNALHEMMER FÜR NEU DIAGNOSTIZIERTES GLIOBLASTOM: EINE RANDOMISIERTE, OFFENE, MULTIZENTRISCHE PHASE IB/II STUDIE |
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Title in English |
A phase Ib/II randomized, open label drug repurposing trial of glutamate signaling inhibitors in combination with chemoradiotherapy in patients with newly diagnosed glioblastoma (GLUGLIO) |
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Phase/Biobank/ect. |
Ib/II |
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Description |
The study examines the effectiveness of a combination of the study drugs gabapentin, sulfasalazine and memantine together with standard therapy (radiotherapy and chemotherapy with temozolomide). All three study drugs inhibit the glutamate signaling pathway at different points. Glutamate is a messenger substance found in the human brain that is released by both glioblastoma cells and brain cells. Glutamate promotes the growth and invasion of glioblastoma cells into healthy brain tissue. This is intended to be prevented by additional administration of the three study drugs. |
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Head Clinical Trial |
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Study-Nurse |
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Status |
open for patient recruitment: 01.05.2023 |
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BASEC Nummer |
BASEC2022-01877 |
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KOFAM |
SNCTP000005305 |
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EudraCT No. |
NCT05664464 |
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Insel-Nummer |
5419 |
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 |
MP0533-CP101
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Title in German |
Eine Studie mit MP0533 bei Patienten mit Blutkrebs |
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Title in English |
A phase 1/2a, first-in-human, open-label, multicenter study of MP0533 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB2) |
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Description |
This study examines the study drug MP0533, which is being used in patients for the first time. Only patients diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) can take part in the study. MP0533 is designed to selectively bind to and kill cancer cells in the blood and bone marrow. It is expected to activate the body's immune system and trigger an immune response against the cancer to kill the cancer cells. Therefore, MP0533 offers a novel and innovative treatment option to be tested in humans. MP0533 has been shown to be safe in animal studies. Treatment with MP0533 aims to address the high unmet medical need for patients with recurrent or difficult-to-treat leukemia or myelodysplastic syndrome. In this study, we examine how safe the new study drug MP0533 is and how well it works. We are testing MP0533 at various dosages to define the safest and most efficient dosing regimen of study drug MP0533 for future studies. We also want to learn more about the distribution and concentration of the study drug in the blood and bone marrow and how it affects the body, its effect on the cancer cells, and the ability of the study drug to trigger an unwanted immune response in the body. The study is a multicenter international study. The participating centers are located in Europe (Netherlands and Switzerland). Two locations in Switzerland were selected to take part in the present clinical study. |
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Phase/Biobank/ect. |
1/2a |
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Head of Clincial Trial |
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Study-Nurse |
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Back-up |
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Back-up |
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Status |
temp. closed for patient recruitment since 21.04.2024 |
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BASEC Nummer |
2022-01615 |
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KOFAM |
SNCTP000005268 |
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EudraCT No. |
EUCTR2022-002432-31 |
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WHO-Register-Nummer |
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Insel-Nummer |
5294 |
Roche BO44426 Krascendo
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Title in German |
Eine offene, multizentrische Phase-Ib/II-Studie zur Bewertung der Sicherheit, Wirksamkeit und Pharmakokinetik von GDC-6036 in Kombination mit anderen onkologischen Therapien bei Patienten mit zuvor nicht behandeltem fortgeschrittenem oder metastasiertem nicht-kleinzelligem Lungenkarzinom mit einer KRAS G12C- Mutation. |
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Title in English |
A PHASE Ib/II, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, ACTIVITY, AND PHARMACOKINETICS OF GDC-6036 IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC NON−SMALL CELL LUNG CANCER WITH A KRAS G12C MUTATION |
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Phase |
I |
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Description |
This clinical trial will enroll patients with locally advanced or metastatic NSCLC that has not been previously treated. In addition, the NSCLC must be positive for PD-L1 protein and have the KRAS G12C mutation. The goal of this clinical trial is to test the safety and activity of GDC-6036 at various dosages in combination with pembrolizumab and to understand how the body processes these medications. Participants will receive the clinical trial treatment GDC-6036 in combination with pembrolizumab in 21-day treatment periods (called “treatment cycles”) until their investigator determines that they no longer benefit from the treatment. Participants will see the investigator every week for the first three treatment cycles, then every two weeks during cycles 4 and 5, and then every three weeks for the remaining treatment cycles. During these hospital visits, we will also check how the participant is responding to the treatment and whether they are experiencing any side effects. The total length of time participants take part in the clinical trial depends on how their NSCLC responds to treatment. It can last a day or more than 2 years. After administering the last dose of clinical study treatment, the investigator will examine participants every three months as long as they agree. Participants may discontinue study treatment and withdraw from the clinical trial at any time. |
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Head Clinical Trial |
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Study Nurse |
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Study Nurse |
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Status |
open for patient recruitment since Dec. 2023 (only arm: Divarasib 400mg + Pembrolizumab vs Divarasib 200mg + Pembrolizumab) |
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BASEC-Nummer |
2023-01265 |
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KOFAM |
SNCTP000005646 |
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Insel-Nummer |
5524 |