Clinical trials: P53 Mutation
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.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Phase 1/1b, open label, multi-center dose escalation and dose expansion study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 alone or in combination…
- Trial name
- NCT02909972
- Testing
- ALRN-6924, ALRN-6924 in combination with cytarabine
- Where
- 6 sites in United States
- Volunteers
- 55 people
- Sponsor
- Aileron Therapeutics, Inc.
Advanced Solid Tumor, CDKN2A
Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss
This is an open-label, single-arm, Phase 1b/2 study designed to evaluate the safety, tolerability, and preliminary efficacy of milademetan in combination with atezolizumab in patients with advanced solid tumors with confirmed…
- Conditions
- Advanced Solid Tumor, CDKN2A, NSCLC, Urothelial Carcinoma Bladder
- Trial name
- NCT06090318
- Testing
- Milademetan, Atezolizumab
- Sponsor
- Rain Oncology Inc
Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53
p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246
The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum…
- Trial name
- NCT02098343
- Testing
- APR-246, Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
- Where
- 55 sites in United States, Belgium and 6 more
- Volunteers
- 247 people
- Sponsor
- Aprea Therapeutics
Advanced Soft Tissue Sarcoma, Undifferentiated Pleomorphic Sarcoma (UPS)
Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma
This study is open to adults with specific types of advanced soft tissue sarcoma. People with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) can join the study if they have a normal version of the TP53 gene.
- Conditions
- Advanced Soft Tissue Sarcoma, Undifferentiated Pleomorphic Sarcoma (UPS), Myxofibrosarcoma (MFS)
- Trial name
- NCT06370871
- Testing
- Brigimadlin, Ezabenlimab, Gemcitabine
- Sponsor
- Boehringer Ingelheim
Acute Myeloid Leukemia or Myelodysplastic Syndromes
APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant
A multi-center, open label, Phase II clinical trial to assess the safety and efficacy of APR-246 in combination with azacitidine as maintenance therapy after allogeneic HSCT (hematopoietic stem cell transplant) for patients with…
- Trial name
- NCT03931291
- Testing
- APR-246
- Where
- 7 sites in United States
- Volunteers
- 33 people
- Sponsor
- Aprea Therapeutics
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
Pancreatic Neoplasms, Solid Tumors
Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder
This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists.
- Conditions
- Pancreatic Neoplasms, Solid Tumors, Biliary Tract Cancer, Lung Neoplasms
- Trial name
- NCT05512377
- Testing
- Brigimadlin
- Where
- 60 sites in United States, Australia and 14 more
- Volunteers
- 99 people
- Sponsor
- Boehringer Ingelheim
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
Cancer
Study of SNX-5422 in TP53 Null Cancers
SNX-5422 is a pro-drug of SNX-2112, a potent, highly selective, small-molecule inhibitor of the molecular chaperone heat shock protein 90 (Hsp90).
- Trial name
- NCT02612285
- Testing
- SNX-5422
- Where
- 5 sites in United States
- Volunteers
- 1 people
- Sponsor
- Esanex Inc.
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
Chronic Lymphocytic Leukemia (CLL)
A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
The purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on the quality of life of participants including those with with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL; a type of…
- Trial name
- VENICE II (NCT02980731)
- Testing
- Venetoclax
- Where
- 33 sites in Argentina, Australia and 8 more
- Volunteers
- 210 people
- Sponsor
- AbbVie
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
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.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or…
- Trial name
- NCT04477291
- Testing
- CG-806
- Where
- 10 sites in United States
- Volunteers
- 45 people
- Sponsor
- Aptose Biosciences 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