Clinical trials: P53 Mutation
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.
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.
Acute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome (MDS)
HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)
This was a phase 1b, multi-arm, open-label study of HDM201 in combination with MBG453 or venetoclax in subjects with AML or high-risk MDS.
- Trial name
- NCT03940352
- Testing
- HDM201, MBG453, Venetoclax
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
CLN-049-001 is a Phase 1/2, open-label, multicenter, first-in-human trial of CLN-049 in patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
- Conditions
- Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), TP53-mutated MDS and AML
- Trial name
- NCT05143996
- Testing
- CLN-049
- Where
- 17 sites in United States
- Volunteers
- 275 people
- Sponsor
- Cullinan Therapeutics Inc.
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
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.
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
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.
Acute Myeloid Leukemia
TL-895 and KRT-232 Study in Acute Myeloid Leukemia
This study evaluates TL-895, a potent, orally available and highly selective irreversible tyrosine kinase inhibitor combined with navtemadlin (KRT-232), a novel oral small molecule inhibitor of MDM2 for the treatment of adults…
- Trial name
- NCT04669067
- Testing
- TL-895, KRT-232
- Where
- 35 sites in United States, Australia and 6 more
- Volunteers
- 18 people
- Sponsor
- Telios Pharma, 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
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
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
MDS
APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)
A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.
- Trial name
- NCT03745716
- Testing
- APR-246 + azacitidine, Azacitidine
- Where
- 27 sites in United States, France
- Volunteers
- 154 people
- Sponsor
- Aprea Therapeutics
Acute Myeloid Leukemia
Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated
The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53…
- Trial name
- ENHANCE-2 (NCT04778397)
- Testing
- Magrolimab, Venetoclax, Azacitidine
- Where
- 156 sites in United States, Australia and 13 more
- Volunteers
- 258 people
- Sponsor
- Gilead Sciences
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.
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
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
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
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