Clinical trials: TP53 Gene Mutation
AML (Acute Myeloid Leukemia)
A Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML Patients
A Phase 1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously (IV) administered CLN-049 in combination with…
- Trial name
- NCT07722767
- Testing
- CLN-049, Azacitidine, Venetoclax
- Where
- 3 sites in United States
- Volunteers
- 90 people
- Sponsor
- Cullinan Therapeutics Inc.
Advanced Non-small Cell Lung Cancer
Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance
To evaluate the efficacy and safety of almonertinib plus anlotinib as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation. This study is an exploratory single-arm study.
- Trial name
- NCT06043973
- Testing
- almonertinib
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Qianfoshan Hospital
Myeloid Leukemia, Myelodysplastic Syndromes
Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT
To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry…
- Trial name
- NCT06130579
- Testing
- IFN-Α
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Peking University People's Hospital
Breast Cancer, TP53 R337H
Phenotype and Prognosis of Patients With Breast Cancer and Pathogenic Variants of TP53
A prospective and retrospective cohort study of patients with a documented pathogenic or likely pathogenic variants of TP53 were identified using blood DNA colection and breast cancer diagnosis by histological confirmation…
- Conditions
- Breast Cancer, TP53 R337H, Li-Fraumeni Syndrome, Prognosis Breast Cancer
- Trial name
- BREAST-TP53 (NCT04966923)
- Testing
- No intervention in this study
- Where
- Brazil
- Volunteers
- 135 people
- Sponsor
- Instituto do Cancer do Estado de São Paulo
Myelodysplastic Syndrome With Gene Mutation, Acute Myeloid Leukemia With Gene Mutations
Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine
The main purpose of this study is to determine the safe and efficacy of APR-246 in combination with azacitidine as well as to see complete remission of this patients
- Conditions
- Myelodysplastic Syndrome With Gene Mutation, Acute Myeloid Leukemia With Gene Mutations, Myeloproliferative Neoplasm, Chronic Myelomonocytic Leukemia
- Trial name
- NCT03588078
- Testing
- APR-246, Azacitidine
- Where
- 7 sites in France
- Volunteers
- 53 people
- Sponsor
- Groupe Francophone des Myelodysplasies
DLBCL
CD-RCHOP in ND DLBCL With a Combination of TP53 Mutation and Del(17p)
This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of…
- Trial name
- NCT06750991
- Testing
- CDR-CHOP
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Ruijin Hospital
Graves' Disease
Genetic Polymorphisms Associated With Cigarette Smoking and Risk of Graves' Disease
Cigarette smoking is a well-recognized risk factor of Graves' disease and, particularly, Graves' ophthalmopathy. Hence, germline polymorphisms of detoxification genes and genes belonging to the major DNA repair/apoptosis pathways…
- Trial name
- NCT00505011
- Volunteers
- 1,998 people, healthy volunteers welcome
- Sponsor
- University of Campinas, Brazil
Ovarian Cancer, Small Cell Lung Cancer
A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation
This is a first-in-human, Phase 1/2, open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of LG00313112 in participants with advanced solid malignancies harboring a TP53 Y220C…
- Conditions
- Ovarian Cancer, Small Cell Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer
- Trial name
- NCT07752875
- Testing
- LG00313112
- Volunteers
- 250 people
- Sponsor
- LG Chem
Medulloblastoma
Arsenic Trioxide Combined With Chemotherapy for Relapsed SHH-Activated and/or TP53-Mutant Medulloblastoma
This prospective, open-label, single-arm, multicenter study will evaluate the efficacy and safety of arsenic trioxide (ATO) combined with chemotherapy in pediatric patients with relapsed or refractory SHH-activated…
- Trial name
- NCT07856069
- Testing
- Arsenic Trioxide (ATO), ETOPOSIDE - Study, Cisplatin
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Acute Myeloid Leukemia, TP53 Gene Mutation
Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML
Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients
- Trial name
- NCT07511062
- Testing
- Decitabine, Venetoclax, Axatilimab
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Northside Hospital, Inc.
Endometrial Carcinoma, TP53 Mutation
Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer
This study is an open-label Phase II randomized controlled trial designed to evaluate the safety and efficacy of camrelizumab plus fluzoparib maintenance therapy in patients with recurrent or metastatic TP-53 mutated Endometrial…
- Conditions
- Endometrial Carcinoma, TP53 Mutation, Recurrent or Metastatic
- Trial name
- NCT06413992
- Testing
- Fluzoparib, Camrelizumab, paclitaxel (albumin bound)
- Where
- China
- Volunteers
- 117 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Non-small Cell Carcinoma, EGFR Gene Mutation
Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations
This is a phase III randomized trial in patients with advanced non-squamous NSCLC harboring EGFR-sensitizing mutations and concurrent TP53 mutations with a performance status of 0 to1 who are planned to receive first-line therapy.
- Trial name
- TOP (NCT04695925)
- Testing
- Osimertinib, Pemetrexed, Carboplatin
- Where
- 2 sites in China
- Volunteers
- 294 people
- Sponsor
- Li Zhang, MD
Ovarian Cancer
A Study of Adavosertib (MK-1775) in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone for Participants With Platinum-Sensitive Ovarian Tumors With the P53 Gene Mutation (MK-1775-004)
This is a study of the safety and efficacy of adavosertib in combination with paclitaxel plus carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with the P53 mutation.
- Trial name
- NCT01357161
- Testing
- adavosertib, paclitaxel, carboplatin
- Volunteers
- 136 people
- Sponsor
- Merck Sharp & Dohme LLC
Solid Tumor, Adult, Lymphoma
Combination of CAR-DC Vaccine and ICIs in Malignant Tumors
This is a pilot clinical trial for subjects with local advanced/metastatic solid tumors or relapsed/refractory (R/R) lymphomas to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine…
- Conditions
- Solid Tumor, Adult, Lymphoma, EphA2 Overexpression, TP53 R273H
- Trial name
- NCT05631886
- Testing
- TP53-EphA-2-CAR-DC, Abraxane, Cyclophosphamide
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Chinese PLA General Hospital
Non Small Cell Lung Cancer
Efficacy Study of Osimertinib in Treatment-naïve Patients With EGFR Mutant NSCLC According to TP53 Mutational Status.
This is a prospective, biomarker-driven, open-label, clinical trial of osimertinib in treatment- naïve patients with EGFR mutant NSCLC, to evaluate the efficacy of osimertinib according to the TP53 mutational status.
- Trial name
- TEMPLE-2 (NCT05785208)
- Testing
- Osimertinib
- Where
- 11 sites in Italy
- Volunteers
- 122 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Li-Fraumeni Syndrome
A Pilot Study of Metformin in Patients With a Diagnosis of Li-Fraumeni Syndrome
Background: Li Fraumeni Syndrome (LFS) is a highly penetrant, autosomal dominant cancer predisposition disorder. Four main cancer types including sarcoma, adrenocortical carcinoma, breast cancer, and malignant brain tumors…
- Trial name
- NCT01981525
- Testing
- Metformin
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- National Cancer Institute (NCI)
Anaplastic Astrocytoma, Anaplastic Ependymoma
SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors
Approximately 90% of children with malignant brain tumors that have recurred or relapsed after receiving conventional therapy will die of disease.
- Conditions
- Anaplastic Astrocytoma, Anaplastic Ependymoma, Anaplastic Ganglioglioma, Anaplastic Meningioma
- Trial name
- NCT03434262
- Testing
- Gemcitabine, ribociclib, sonidegib
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- St. Jude Children's Research Hospital
Ovarian Cancer, Endometrial Cancer
Arsenic Trioxide in Recurrent and Metastatic Ovarian Cancer and Endometrial Cancer With P53 Mutation
This study is a Single-center, open, single-arm and non-randomized clinical trial in China. The aim of this study is to evaluate the efficacy, safety, and tolerability of Arsenic trioxide for injection in patients with recurrent…
- Trial name
- NCT04489706
- Testing
- Arsenic trioxide for injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Ruijin Hospital
Advanced Solid Tumors
Study of AMG 650 in Adult Participants With Advanced Solid Tumors
To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
- Trial name
- NCT04293094
- Testing
- AMG 650
- Where
- 22 sites in United States, Australia and 5 more
- Volunteers
- 66 people
- Sponsor
- Volastra Therapeutics, Inc.
CNS Malignancies, Medulloblastoma Recurrent
A Phase 0/1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.
This clinical trial is studying a drug called SGT-53 along with radiation and another drug called Nivolumab. It's for children with brain tumors that have come back, gotten worse, or didn't get better with earlier treatments.
- Conditions
- CNS Malignancies, Medulloblastoma Recurrent, ATRT Recurrent, Pineoblastoma
- Trial name
- JACOB (NCT07017816)
- Testing
- SGT-53, hypofractionated radiotherapy with immunotherapy, Nivolumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Children's National Research Institute