Clinical trials: Genetic Mutation
Dilated Cardiomyopathy
Observational Study of Natural History of BAG3 Gene Mutation-Associated Dilated Cardiomyopathy in Chinese Adults
This is a multicentre, prospective cohort study designed to elucidate the natural history of dilated cardiomyopathy (DCM) associated with specific gene mutations in Chinese patients.
- Trial name
- NCT07646600
- Testing
- Observational, None intervention
- Where
- 3 sites in China
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company
Cystic Fibrosis
A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele
This is a Phase 2 open label study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 with and without ivacaftor in patients with CF with at least one G542X allele or phenotypically…
- Trial name
- NCT04126473
- Testing
- ELX-02, Ivacaftor
- Where
- 9 sites in Australia, Germany and 1 more
- Volunteers
- 17 people
- Sponsor
- Eloxx Pharmaceuticals, 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.
EGFR Mutation Positive Non Small Cell Lung Cancer
First Line Bio-immunotherapy With Thymosin Alpha 1 in Patients With Sensitizing EGFR Mutation Positive Non Small Cell Lung Cancer Who Are Taking Standard of Care Therapy
Phase I: evaluate the safety and tolerability two different dosing regimens of Thymosin alpha 1 in patients with advanced EGFR mutation positive NSCLC on Standard of Care (SoC) therapy.
- Trial name
- NCT02906163
- Testing
- Thymalfasin (Thymosin alpha 1, Ta1), SoC (tyrosine kinase inhibitor)
- Where
- 5 sites in Italy
- Volunteers
- 188 people
- Sponsor
- SciClone Pharmaceuticals
Advanced Solid Tumor, Non Small Cell Lung Cancer
A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)
Phase 1, open-label, multicenter study to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP 5282 when administered to HLA A*03:01-positive adult patients with advanced solid tumors that harbor…
- Conditions
- Advanced Solid Tumor, Non Small Cell Lung Cancer, Pancreatic Carcinoma, Colorectal Cancer
- Trial name
- NCT07650357
- Testing
- CLSP-5282
- Where
- 4 sites in United States
- Volunteers
- 140 people
- Sponsor
- Clasp Therapeutics, Inc.
BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
Special Drug Use-results Surveillance of Tafinlar/Mekinist
This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture.
- Trial name
- NCT06262919
- Testing
- Tafinlar/Mekinist
- Where
- 70 sites in Japan
- Volunteers
- 110 people
- Sponsor
- Novartis Pharmaceuticals
Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with…
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC)
- Trial name
- NCT07349537
- Testing
- RMC-5127, daraxonrasib, cetuximab
- Where
- 9 sites in United States
- Volunteers
- 574 people
- Sponsor
- Revolution Medicines, Inc.
Non-squamous, Non-Small Cell Lung Cancer
Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma
The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC).
- Trial name
- NCT04795245
- Testing
- afatinib
- Where
- Japan
- Volunteers
- 805 people
- Sponsor
- Boehringer Ingelheim
Advanced Non-Small Cell Lung Cancer
Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation.
- Trial name
- NCT05504278
- Testing
- IBI351, Cetuximab, pemetrexed
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Tumors With Aberrations in ALK or ROS1
Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
The purpose of this signal seeking study was to determine whether treatment with ceritinib demonstrated sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
- Trial name
- SIGNATURE (NCT02186821)
- Testing
- Ceritinib
- Where
- 21 sites in United States
- Volunteers
- 47 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer
A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS…
- Trial name
- Krascendo 2 (NCT06793215)
- Testing
- Divarasib, Pembrolizumab, Pemetrexed
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 600 people
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer (NSCLC)
A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations
This study will assess the safety and efficacy of Osimertinib with Amivantamab as First-line Treatment in Participants with Epidermal Growth Factor Receptor Mutation-Positive, Locally Advanced or Metastatic Non-small Cell Lung…
- Trial name
- OSTARA (NCT05801029)
- Testing
- Osimertinib, Amivantamab
- Where
- 28 sites in Hong Kong, Malaysia and 4 more
- Volunteers
- 60 people
- Sponsor
- AstraZeneca
Wilson Disease
Prescreening Study to Identify Potential Wilson Disease Participants for Gene-Editing Clinical Trial
The aim of this study is to inform and improve future clinical trials in Wilson Disease (WD) by better understanding how patients with WD are living with and managing the disease, and by identifying key factors that shape their…
- Trial name
- NCT07226622
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- Prime Medicine, Inc.
Cystic Fibrosis (CF)
Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SION-719 when given to people with CF who are already taking Trikafta.
- Trial name
- PreciSION CF (NCT07108153)
- Testing
- SION-719
- Where
- 13 sites in United States, Australia
- Volunteers
- 15 people
- Sponsor
- Sionna Therapeutics Inc.
Ovarian Cancer
Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India
This is a non-interventional, cross-sectional, multicentre, observational study planned to be conducted at 15 sites across all geographical regions of India.
- Trial name
- BRCA (NCT03471572)
- Where
- 8 sites in India
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Solid Tumor, Adult, Metastatic Solid Tumor
SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with sotorasib, a KRAS-G12C inhibitor (KRAS-G12Ci), in patients with a KRAS-G12C mutation.
- Conditions
- Solid Tumor, Adult, Metastatic Solid Tumor, Metastatic NSCLC, Non Small Cell Lung Cancer
- Trial name
- Argonaut (NCT05480865)
- Testing
- BBP-398, sotorasib
- Where
- 25 sites in Australia, Denmark and 5 more
- Volunteers
- 28 people
- Sponsor
- Navire Pharma Inc., a BridgeBio company
Essential Thrombocythemia
A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.
- Trial name
- EXCALIBUR-ET2 (NCT07623200)
- Testing
- INCA033989, Best Available Treatment
- Where
- 193 sites in United States, Australia and 20 more
- Volunteers
- 426 people
- Sponsor
- Incyte Corporation
Non Small Cell Lung Cancer, KRAS Activating Mutation
Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with sotorasib with or without defactinib in patients with KRAS G12C Non-Small Cell Lung Cancer (NSCLC) in patients who have been exposed to…
- Trial name
- RAMP203 (NCT05074810)
- Testing
- avutometinib and sotorasib, avutometinib and sotorasib and defactinib
- Where
- 35 sites in United States, Belgium and 4 more
- Volunteers
- 153 people
- Sponsor
- Verastem, Inc.
KRAS P.G12D
A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.
This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants…
- Trial name
- NCT07456046
- Testing
- D3S-003
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 42 people
- Sponsor
- D3 Bio (Wuxi) Co., Ltd
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