Clinical trials: Genetic Mutation
Lung Neoplasm, Carcinoma, Non-Small-Cell Lung
(HARMONY) Study of BLU-701 in EGFR-mutant NSCLC
This is a Phase 1/2, open-label, first-in-human (FIH) study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of BLU-701 as monotherapy or in combination with either…
- Conditions
- Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Neoplasms
- Trial name
- NCT05153408
- Testing
- BLU-701, osimertinib, carboplatin
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Blueprint Medicines Corporation
Chronic Phase Chronic Myelogenous Leukemia, Accelerated Phase Chronic Myelogenous Leukemia
CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey
A multicenter, prospective cohort study of the mutation status of patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are being treated with first or…
- Conditions
- Chronic Phase Chronic Myelogenous Leukemia, Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
- Trial name
- NCT03647215
- Where
- 33 sites in Ireland, United Kingdom
- Volunteers
- 427 people
- Sponsor
- Incyte Biosciences UK
Leber's Congenital Amaurosis
Study to Evaluate QR-110 in Leber's Congenital Amaurosis (LCA) Due to the c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene
The purpose of this study is to evaluate the safety and tolerability of QR-110 administered via intravitreal injection in subjects with LCA due to the CEP290 p.Cys998X mutation.
- Trial name
- NCT03140969
- Testing
- QR-110
- Where
- 3 sites in United States, Belgium
- Volunteers
- 11 people
- Sponsor
- Laboratoires Thea
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
- Conditions
- Cancer, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC (Non-small Cell Lung Cancer), CRC (Colorectal Cancer)
- Trial name
- NCT06835569
- Testing
- ALTA3263, cetuximab, mFOLFOX6
- Where
- 14 sites in United States
- Volunteers
- 448 people
- Sponsor
- Alterome Therapeutics, Inc.
Solid Tumor
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR…
- Trial name
- NCT01752920
- Testing
- Derazantinib low dose range, Derazantinib middle dose range, Derazantinib high dose range
- Where
- 12 sites in United States, Italy
- Volunteers
- 119 people
- Sponsor
- Basilea Pharmaceutica
KRAS Positive Patients With Non-small Cell Lung Cancer, Squamous Cell Non-small Cell Lung Cancer
A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer
BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who…
- Trial name
- NCT02283320
- Testing
- BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
- Where
- 32 sites in United States, Russia
- Volunteers
- 69 people
- Sponsor
- BIND Therapeutics
Triple-Negative Breast Cancer (TNBC), Gastric Cancer (GC)
A Study of MDSY-1240, a STAT3 Degrader, for the Treatment of Hematologic Malignancies and Advanced Solid Tumors
This clinical trial is evaluating a drug called MDSY-2140 in participants with hematologic malignancies and advanced solid tumors.
- Conditions
- Triple-Negative Breast Cancer (TNBC), Gastric Cancer (GC), Gastric Cancer Adenocarcinoma Metastatic, Ovarian Cancer Metastatic
- Trial name
- NCT07899632
- Testing
- MDSY-1240
- Volunteers
- 75 people
- Sponsor
- Medsyn Biopharma, LLC
Non Small Cell Lung Cancer
Epidemiological Study to Evaluate the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).
- Trial name
- Spanish REASON (NCT01081496)
- Where
- 24 sites in Spain
- Volunteers
- 1,000 people
- Sponsor
- AstraZeneca
Prostate Cancer
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation
The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival…
- Trial name
- EvoPAR-PR02 (NCT06952803)
- Testing
- Saruparib, Abiraterone + Prednisolone/Prednisone, Androgen Deprivation Therapy (ADT)
- Where
- 346 sites in United States, Argentina and 26 more
- Volunteers
- 700 people
- Sponsor
- AstraZeneca
Ovarian Carcinoma, Breast Cancer
Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer
This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to…
- Trial name
- NCT00679783
- Testing
- AZD2281
- Where
- 6 sites in Canada
- Volunteers
- 99 people
- Sponsor
- AstraZeneca
Cystic Fibrosis
Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation)
32 cystic fibrosis patients with the G551D mutation will be treated for 4 weeks, consisting of three consecutive treatment periods: two 1-week periods followed by one 2-week period, evaluating one dose of GLPG1837 each.
- Trial name
- SAPHIRA1 (NCT02707562)
- Testing
- GLPG1837 dose 1, GLPG1837 dose 2, GLPG1837 dose 3
- Where
- 16 sites in Australia, Czechia and 3 more
- Volunteers
- 26 people
- Sponsor
- Lakefront Biotherapeutics NV
Uterine Neoplasms, Uterine Cervical Neoplasms
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the…
- Conditions
- Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms
- Trial name
- NCT04579380
- Testing
- tucatinib, trastuzumab, fulvestrant
- Where
- 108 sites in United States, Belgium and 6 more
- Volunteers
- 217 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
VEXAS Syndrome
A 52-Week Study Evaluating the Efficacy and Safety of Arumakimig (MAS825) in Participants With VEXAS Followed by Open-Label Extension (OLE) Period
The purpose of this study is to evaluate clinical efficacy and safety of arumakimig (MAS825) compared to placebo in patients with Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) syndrome.
- Trial name
- NCT07748624
- Testing
- Arumakimig, Oral glucocorticoids
- Where
- 4 sites in Japan
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Mitochondrial Diseases, Mitochondrial Myopathies
The KHENERGY Study
Mitochondrial Diseases are rare, progressive, multi-system, often-early fatal disorders affecting both children and adults. KH176 is a novel chemical entity currently under development for the treatment of inherited mitochondrial…
- Conditions
- Mitochondrial Diseases, Mitochondrial Myopathies, Mitochondrial Encephalomyopathies, MELAS
- Trial name
- KHENERGY (NCT02909400)
- Testing
- KH176
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Khondrion BV
Parkinson's Disease
Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A in PD-GBA Patients
This is a randomized, placebo-controlled, parallel group, patient-blind, single-center phase I clinical trial of repeated once every 4 weeks administration by subcutaneous injection of AFFITOPE® PD01A, adsorbed to aluminium oxide…
- Trial name
- NCT02758730
- Testing
- AFFITOPE® PD01A + Adjuvant, Adjuvant without active component
- Where
- Germany
- Sponsor
- Affiris AG
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)
The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and…
- Trial name
- NCT03730012
- Testing
- gilteritinib, atezolizumab
- Where
- 12 sites in United States
- Volunteers
- 11 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Breast Cancer
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer
The purpose of this study is to assess the safety and efficacy of alpelisib plus fulvestrant in men and postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor 2 (HER2)-negative, advanced breast…
- Trial name
- NCT04524000
- Testing
- Alpelisib, Fulvestrant
- Where
- 15 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
BRAF V600E Mutation Positive, Metastatic Colorectal Cancer
A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for…
- Trial name
- CAPSTAN CRC (NCT04317599)
- Testing
- Non interventional
- Where
- 34 sites in Austria, Belgium and 5 more
- Volunteers
- 274 people
- Sponsor
- Pierre Fabre Medicament
Non-small Cell Lung Cancer
A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment
The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily…
- Trial name
- CodeBreaK201 (NCT04933695)
- Testing
- Sotorasib
- Where
- 67 sites in United States, Belgium and 8 more
- Volunteers
- 42 people
- Sponsor
- Amgen
Breast Neoplasms, Solid Tumors
A Phase 1/2a Study of K-1728 in Advanced Solid Tumors
This first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors.
- Conditions
- Breast Neoplasms, Solid Tumors, PIK3CA Gene Mutation
- Trial name
- PIKYMA-01 (NCT07861932)
- Testing
- K-1728, Fulvestrant, Palbociclib
- Volunteers
- 110 people
- Sponsor
- KymaThera, Inc.
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