Clinical trials: Tp53 Mutations
Solid Tumors
JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
- Trial name
- NCT06386146
- Testing
- JAB-30355
- Where
- 15 sites in United States, China
- Volunteers
- 144 people
- Sponsor
- Jacobio Pharmaceuticals Co., Ltd.
Chronic Lymphocytic Leukemia
A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL)
The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation, including those who have received prior treatment…
- Trial name
- VENICE I (NCT02756611)
- Testing
- Venetoclax
- Where
- 67 sites in United States, Austria and 19 more
- Volunteers
- 258 people
- Sponsor
- AbbVie
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.
Advanced Solid Tumors
A Study of Safety, Tolerability and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation
This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.
- Trial name
- NTS071 (NCT07060989)
- Testing
- NTS071
- Where
- 10 sites in United States, China
- Volunteers
- 220 people
- Sponsor
- Nutshell Therapeutics (Shanghai) Co., LTD.
Chronic Lymphocytic Leukemia
Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in…
- Trial name
- AMPLIFY (NCT03836261)
- Testing
- Acalabrutinib, Venetoclax, Chemoimmunotherapy
- Where
- 169 sites in United States, Argentina and 25 more
- Volunteers
- 984 people
- Sponsor
- Acerta Pharma BV
Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation
Adavosertib Plus Chemotherapy in Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Adavosertib in combination with carboplatin, paclitaxel, gemcitabine, or PLD.
- Trial name
- NCT02272790
- Testing
- Adavosertib, Paclitaxel, Carboplatin
- Where
- 20 sites in United States, Canada and 1 more
- Volunteers
- 95 people
- Sponsor
- AstraZeneca
Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma
A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors
This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of APG-115, an MDM2 inhibitor, either alone or in combination with pembrolizumab, a programmed cell death protein-1 (PD-1) inhibitor…
- Conditions
- Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma, Uveal Melanoma, P53 Mutation
- Trial name
- NCT03611868
- Testing
- Phase 1b: APG-115+pembrolizumab
- Where
- 21 sites in United States, Australia
- Volunteers
- 230 people
- Sponsor
- Ascentage Pharma Group Inc.
Healthy Volunteers
A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants
This study will assess the effect of a Proton Pump Inhibitor (PPI) (rabeprazole) on the pharmacokinetics (PK) of PC14586 and the effect of an H2-receptor antagonist (famotidine) on the PK of PC14586
- Trial name
- NCT06054464
- Testing
- PC14586, Rabeprazole, Famotidine
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- PMV Pharmaceuticals, Inc
CLL / SLL, CLL (Chronic Lymphocytic Leukemia)
ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
This is a Phase 3, randomized, open-label, multicenter study comparing rocbrutinib (LP-168) versus pirtobrutinib in adult participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma…
- Conditions
- CLL / SLL, CLL (Chronic Lymphocytic Leukemia), CLL, Refractory, CLL, Relapsed
- Trial name
- NCT07342478
- Testing
- Rocbrutinib, Pirtobrutinib
- Where
- 6 sites in United States
- Volunteers
- 306 people
- Sponsor
- Newave Pharmaceutical Inc
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
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.
Solid Tumors Harboring a TP53 Y220C Mutation
A Phase I First-in-Human Study of GenSci128 in Patients With Solid Tumors Harboring a TP53 Y220C Mutation
The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation
- Trial name
- NCT06908434
- Testing
- GenSci128 tablets
- Where
- China
- Volunteers
- 82 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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
Diffuse Large B-Cell Lymphoma
First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP
Diffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma。The majority of refractory patients have PD-L1 expression due to P53 mutations, some of which account for about 10% of DLBCL.Our department has found that…
- Trial name
- NCT05280626
- Testing
- Sintilimab, Rituximab
- Volunteers
- 100 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
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
Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies
- Conditions
- Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma
- Trial name
- NCT05877599
- Testing
- NT-175
- Where
- 20 sites in United States
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
Relapsed/Refractory Acute Myeloid Leukemia
Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who…
- Trial name
- NCT06549790
- Testing
- NMS-03597812
- Where
- 7 sites in United States
- Volunteers
- 124 people
- Sponsor
- Nerviano Medical Sciences
Chronic Lymphocytic Leukemia (CLL)
A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation
This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a…
- Trial name
- CRISTALLO (NCT04285567)
- Testing
- Obinutuzumab, Venetoclax, Fludarabine
- Where
- 40 sites in United States, Australia and 3 more
- Volunteers
- 166 people
- Sponsor
- Hoffmann-La Roche
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Trial name
- NCT02337829
- Testing
- Acalabrutinib (Arm A), Acalabrutinib (Arm B)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Acerta Pharma BV
TP53 Y220C Mutation, Advanced Solid Tumors
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.
This study aims to evaluate the effects of rezatapopt on the pharmacokinetics of metformin, rosuvastatin, repaglinide, and midazolam in patients with advanced solid tumors harboring a TP53 Y220C mutation.
- Trial name
- NCT07372625
- Testing
- metformin hydrochloride 500 mg tablet, rosuvastatin 10 mg tablet, repaglinide 0.5 mg tablet
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- PMV Pharmaceuticals, Inc