Clinical trials: TP53 Gene Mutation
Leukemia, Brain Tumor
Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer
This research study is studying a novel drug called ALRN-6924 as a possible treatment for resistant (refractory) solid tumor, brain tumor, lymphoma or leukemia.
- Conditions
- Leukemia, Brain Tumor, Solid Tumor, Lymphoma
- Trial name
- NCT03654716
- Testing
- ALRN-6924, Cytarabine
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Dana-Farber Cancer Institute
P53 Mutation, Myeloid Malignancy
Mutant p53-based Personalized Trial Using Decitabine and Arsenic Trioxide on AML/MDS
TP53 mutation is commonly associated with poor cancer patient prognosis yet no mutant p53 (mp53)-targeting regimen was clinically established.
- Conditions
- P53 Mutation, Myeloid Malignancy, MDS, Aml
- Trial name
- PANDA-T0 (NCT03855371)
- Testing
- Decitabine, Arsenic Trioxide
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Ruijin Hospital
Hematologic Malignancy, Acute Leukemia
MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies.
- Conditions
- Hematologic Malignancy, Acute Leukemia, Remission, Acute Myeloid Leukemia
- Trial name
- NCT05735717
- Testing
- Fludarabine, Busulfan, Melphalan
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Epcoritamab Plus Venetoclax Plus Ibrutinib in Patients With Chronic Lymphocytic Leukemia With TP53 Alterations
This is a phase 2, open-label, multicenter study evaluating the efficacy and safety of a fixed-duration combination of epcoritamab, venetoclax, and ibrutinib (EVI) in previously untreated patients with chronic lymphocytic…
- Trial name
- EVITA (NCT07738887)
- Testing
- Ibrutinib Oral Tablet, Venetoclax Oral Tablet, Epcoritamab
- Where
- 29 sites in Belgium, France
- Volunteers
- 44 people
- Sponsor
- The Lymphoma Academic Research Organisation
P53 Mutation in Esophageal Cancer
ESCC Molecular Subtypes Based on Multidimensional Features of p53 and Their Clinical Significance
Collect 300 esophageal cancer tissue specimens, including cancer tissue and serum, from a biological sample bank. Collect clinical information on esophageal cancer, including gender, age, time of diagnosis, time of death…
- Trial name
- NCT07722819
- Testing
- No intervention
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Ling Zhiqiang
Prevention of Chemotherapy-induced Myelosuppression
A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with…
- Trial name
- NCT05622058
- Testing
- ALRN-6924, TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)
- Where
- 14 sites in United States, Bosnia and Herzegovina and 2 more
- Volunteers
- 6 people
- Sponsor
- Aileron Therapeutics, Inc.
Medulloblastoma Recurrent, Medulloblastoma, Childhood, Recurrent
Relapsed and Progressive Sonic Hedgehog Medulloblastoma With U1 Mutation Registry Study
The purpose of this study is to create a biobank for patients diagnosed with Sonic Hedgehog Medulloblastoma at Baylor College of Medicine/Texas Children's Cancer Center.
- Conditions
- Medulloblastoma Recurrent, Medulloblastoma, Childhood, Recurrent, Medulloblastoma, SHH-activated and TP53 Mutant, Medulloblastoma, SHH-activated and TP53 Wildtype
- Trial name
- NCT07242963
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Mohammad H. Abu Arja
Solid Tumor
Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53
Study ASTX295-01 is a first in human Phase 1/2 open-label study of the safety, pharmacokinetics, and preliminary activity of ASTX295 in participants with wild-type TP53 advanced solid tumors.
- Trial name
- NCT03975387
- Testing
- ASTX295
- Where
- 11 sites in United States
- Volunteers
- 106 people
- Sponsor
- Taiho Oncology, Inc.
Chronic Lymphocytic Leukemia
A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL
This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the…
- Trial name
- NCT05197192
- Testing
- Obinutuzumab, Venetoclax, Acalabrutinib
- Where
- 30 sites in Germany
- Volunteers
- 202 people
- Sponsor
- German CLL Study Group
Mantle Cell Lymphoma (MCL)
Frontline Risk-Adapted Optimization of Novel Targeted Immunotherapy Evaluation in High-Risk MCL
FRONTIER is a prospective, single arm, open label, multi-center, Phase II study of MB-CART2019.1 (Zamtocabtagene Autoleucel) therapy as frontline consolidation for high-risk Mantle Cell Lymphoma (MCL) participants
- Trial name
- FRONTIER (NCT07569965)
- Testing
- zamtocabtagene autoleucel (MB-CART2019.1), Cyclophosphamide, Fludarabine
- Volunteers
- 52 people
- Sponsor
- Miltenyi Biomedicine GmbH
DLBCL - Diffuse Large B Cell Lymphoma, TP53
AZA Combined With RCHOP in P53-mutated DLBCL.
To evaluate the efficacy and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma
- Trial name
- NCT06158399
- Testing
- Azacitidine in combination with R-CHOP
- Where
- China
- Volunteers
- 52 people
- Sponsor
- The First Affiliated Hospital of Xiamen University
Locally Advanced Resectable Oral Cavity Squamous Cell Cancer
Preoperative TPF Chemotherapy in Molecularly Selected Locally Advanced Resectable Oral Cavity Squamous Cell Cancer
This is a phase II study of preoperative chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) in locally advanced resectable oral cavity squamous cell cancer.
- Trial name
- NCT01914900
- Testing
- docetaxel, cisplatin, 5 fluorouracil
- Where
- Italy
- Volunteers
- 14 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Small Cell Lung Cancer
Phase II, Single-arm Study of AZD1775 Monotherapy in Relapsed Small Cell Lung Cancer Patients With MYC Family Amplification or CDKN2A Mutation Combined With TP53 Mutation
AZD1775 (previously known as MK-1775 in earlier studies) is an inhibitor of Wee1, a protein tyrosine kinase. Wee1 phosphorylates and inhibits cyclin-dependent kinases 1 (CDK1) and 2 (CDK2), and is involved in regulation of the…
- Trial name
- NCT02688907
- Testing
- AZD1775
- Where
- South Korea
- Volunteers
- 7 people
- Sponsor
- Samsung Medical Center
Non-Small Cell Lung Cancer
Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation
This is a prospective, single-arm, multicenter, phase II study to investigate the efficacy and safety of Ensartinib plus Bevacizumab in metastatic anaplastic lymphoma kinase (ALK)-rearranged Non-Small Cell Lung Cancer (NSCLC)…
- Trial name
- EAGLE (NCT05491811)
- Testing
- Ensartinib, Bevacizumab
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Sun Yat-sen University
Non-squamous Metastatic Non-Small-Cell Lung Carcinoma
NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
This prospective, multicenter, non-interventional study (NIS) in Germany aims to collect real-life data of patients with non-squamous (NSQ) metastatic non-small cell lung cancer (mNSCLC) (incl.
- Trial name
- NAUTIC (NCT06494540)
- Where
- 30 sites in Germany
- Volunteers
- 600 people
- Sponsor
- AstraZeneca
Advanced Solid Tumor, Unresectable Solid Tumor
A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.
- Conditions
- Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor, Colorectal Adenocarcinoma
- Trial name
- GUARDIAN-101 (NCT06778863)
- Testing
- CLSP-1025
- Where
- 21 sites in United States
- Volunteers
- 90 people
- Sponsor
- Clasp Therapeutics, Inc.
Adult Solid Neoplasm, Bladder Carcinoma
Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
This phase I trial studies the side effects of vaccine therapy and pembrolizumab in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment, that…
- Conditions
- Adult Solid Neoplasm, Bladder Carcinoma, Colon Carcinoma, Estrogen Receptor Negative
- Trial name
- NCT02432963
- Testing
- Laboratory Biomarker Analysis, Modified Vaccinia Virus Ankara Vaccine Expressing p53, Pembrolizumab
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- City of Hope Medical Center
Advanced Solid Tumors or Non-Hodgkin's Lymphoma (NHL)
A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer
The purpose of this clinical study is to establish the safety profile, determine the maximum tolerated dose (MTD) and recommend a Phase 2 dose and schedule of SRA737; and to evaluate the efficacy of SRA737 in…
- Trial name
- NCT02797964
- Testing
- SRA737
- Where
- 15 sites in United Kingdom
- Volunteers
- 107 people
- Sponsor
- Sierra Oncology LLC - a GSK company
AML, Acute Myeloid Leukemia
A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS
This is a two Part study in patients with relapsed/refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), or high risk myelodysplastic syndrome (MDS) that will initially evaluate the safety and…
- Conditions
- AML, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, CMML
- Trial name
- NCT04358393
- Testing
- APG-115, 5-azacitidine
- Where
- 8 sites in United States
- Volunteers
- 69 people
- Sponsor
- Ascentage Pharma Group Inc.
Ovarian Endometrioid Tumor, Fallopian Tube Cancer
Maintenance Treatment With Bevacizumab and Atezolizumab for Ovarian Cancer
This study is being done to look at the combination of the drugs atezolizumab and bevacizumab as a maintenance treatment (treatment given after the main treatment to keep the cancer from coming back or worsening) following…
- Conditions
- Ovarian Endometrioid Tumor, Fallopian Tube Cancer, Primary Peritoneal Cancer, TP53 Mutation
- Trial name
- NCT04510584
- Testing
- Atezolizumab, Bevacizumab
- Where
- Canada
- Sponsor
- University Health Network, Toronto