Clinical trials: Phase 1, open to volunteers
Solid Tumor (Phase I)
A Phase I Study of ABSK211 in Participants With Advanced Solid Tumors With KRAS Alteration
This is a first-in-human (FIH), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.
- Trial name
- NCT07718165
- Testing
- ABSK211
- Where
- China
- Volunteers
- 247 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Huntington Disease
Optimizing Parameters of Low-Intensity Focused Ultrasound for Pallidal Modulation in Huntington's Disease
The purpose of this research study is to determine the optimal pulse repetition frequency of low-intensity focused ultrasound that is safe and effective in improving motor symptoms in patients with Huntington's disease.
- Trial name
- NCT07513844
- Testing
- Low-Intensity Focused Ultrasound Stimulation（LIFU）
- Where
- China
- Volunteers
- 24 people
- Sponsor
- First Affiliated Hospital of Fujian Medical University
Rheumatic Heart Disease, Rheumatic Heart Disease in Children
Clinical Trial Phase I/IIa to Evaluate the Safety and Immunogenicity of StreptInCor
This is a Phase I/IIa, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to test the candidate vaccine StreptInCor.
- Conditions
- Rheumatic Heart Disease, Rheumatic Heart Disease in Children, Vaccine Adverse Reaction, Rheumatic Diseases
- Trial name
- StreptInCorVac (NCT07078357)
- Testing
- StrepIncor
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Cancer
Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials
Wearable sensors offer opportunities to improve the people's experiences with cancer treatment and to improve care delivery. This is a single-arm, prospective, unblinded pilot study designed to evaluate the feasibility and…
- Trial name
- NCT07541365
- Testing
- Wearable actigraphy, Electronic Patient-Reported Outcomes (ePROs)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Case Comprehensive Cancer Center
Tumor, Solid, Tumor
Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment
This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function.
- Conditions
- Tumor, Solid, Tumor, Advanced Solid Tumor
- Trial name
- NCT05661461
- Testing
- nab-sirolimus
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- Aadi Bioscience, Inc.
Solid Tumor, Lymphoma
A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001）
This is a Phase I study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, LB1410, is safe, tolerable and efficacious in participants with advanced solid tumors or lymphoma.
- Trial name
- NCT05357651
- Testing
- LB1410
- Where
- China
- Volunteers
- 100 people
- Sponsor
- L & L Bio Co., Ltd., Ningbo, China
Juvenile Idiopathic Arthritis
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17.
- Trial name
- JUVE-X (NCT03773965)
- Testing
- Baricitinib
- Where
- 78 sites in Argentina, Australia and 18 more
- Volunteers
- 190 people
- Sponsor
- Eli Lilly and Company
Locally Advanced or Metastatic Solid Tumors
A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors
This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in…
- Trial name
- NCT06349811
- Testing
- BL-M05D1
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Spinal Muscular Atrophy Type I
Study of Safety, Tolerability and Efficacy of GB221 in Infants With Spinal Muscular Atrophy Type 1
GB221 is a gene therapy that delivers a working SMN1 gene to the motor neurons of people with spinal muscular atrophy (SMA) Type 1. This study will evaluate the safety, tolerability and efficacy of GB221 in two groups: 1.
- Trial name
- NCT07070999
- Testing
- GB221
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- Gemma Biotherapeutics
Carcinoma, Non-Small-Cell Lung
JIN-A02 Plus Amivantamab in EGFR-Mutant NSCLC After Third-Generation EGFR-TKI Failure
This Phase 1 study will evaluate the safety, maximum tolerated dose, recommended Phase 2 dose, and preliminary antitumor activity of JIN-A02 in combination with amivantamab in participants with advanced EGFR-mutant non-small cell…
- Trial name
- NCT07798921
- Testing
- JIN-A02 in Combination with Amivantamab
- Volunteers
- 36 people
- Sponsor
- Yonsei University
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Combination Study of Antibiotics With Enzalutamide (PROMIZE)
PROMIZE is an open-label, multi-centre, single-arm, Phase I/II clinical trial, evaluating the safety, tolerability and anti-tumuor efficacy of an antibiotic combination and enzalutamide in patients with metastatic…
- Trial name
- NCT06126731
- Testing
- Enzalutamide 40mg, Amoxicillin 500mg, Metronidazole 400mg
- Where
- 2 sites in Switzerland, United Kingdom
- Volunteers
- 39 people
- Sponsor
- Institute of Cancer Research, United Kingdom
Retinitis Pigmentosa (RP)
Prospective, Randomized, Sham-controlled, Dose-finding I/II Trial of Safety and Efficacy of Modified Optogenetic Gene Therapy (ZM-02 Injection)
This is a Phase 1/2, multi-center, randomized, sham-controlled, dose-escalation study evaluating ZM-02 in patients with advanced retinitis pigmentosa (RP).
- Trial name
- PRISM (NCT07282457)
- Testing
- ZM-02 (low dose), ZM-02 (high dose), ZM-02 (selected dose)
- Volunteers
- 21 people
- Sponsor
- Zhongmou Therapeutics
Endometrial Cancer
Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer
To evaluate the safety, tolerability, and preliminary efficacy of moderately hypofractionated (15-fraction) MR-guided adaptive pelvic IMRT in patients with endometrial cancer.
- Trial name
- ADAPT-EC (NCT07643012)
- Testing
- MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Rutgers, The State University of New Jersey
Solid Tumor Cancer, Medulloblastoma
Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).
Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)
- Conditions
- Solid Tumor Cancer, Medulloblastoma, High Risk Neuroblastoma, High Grade Gliomas
- Trial name
- LUPARPED (NCT06607692)
- Testing
- Olaparib; 177Lu-DOTATATE
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Fundación de investigación HM
Heart Failure
A Clinical Study of HRS-7156 in Healthy Participants
The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.
- Trial name
- NCT07601087
- Testing
- HRS-7156
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
FSHD - Facioscapulohumeral Muscular Dystrophy
Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)
The goal of this clinical trial is to learn about how an umbilical cord lining-derived stem cell product (ULSC) performs when treating Facioscapulohumeral Muscular Dystrophy (FSHD) 1 or 2.
- Trial name
- NCT07086521
- Testing
- ULSC
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Restem, LLC.
B7-H3-positive Advanced Malignant Solid Tumors Advanced Primary Peritoneal Tumors or Secondary Abdominal Metastatic Malignant Solid Tumors
MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors
This is an open-label, single-arm phase I dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of MT027 in patients with advanced primary peritoneal malignancies…
- Trial name
- NCT06912152
- Testing
- MT027 CAR-T cells
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Zhejiang University
Malignant Tumors
PET/CT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors
This prospective, open-label Phase I/II trial evaluates a PET/CT-guided planning strategy for radioactive seed implantation therapy in malignant solid tumors.
- Trial name
- NCT07327515
- Testing
- CT-Guided Radioactive Seed Implantation, PET/CT-Guided Radioactive Seed Implantation, PET/CT-Guided Radioactive Seed Implantation (Biological Dose Optimization)
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Li Min
Obesity & Overweight, Type 2 Diabetes
A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers
Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
- Trial name
- NCT07539415
- Testing
- DWRX5003, DWC202502, DWC202503
- Where
- South Korea
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Parkinson Disease, Parkinson's Disease
A Long-Term Follow-up Study of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product.
The purpose of this study is to evaluate the long-term safety of IPS101A and to assess the durability of efficacy in subjects who received IPS101A.
- Trial name
- NCT07629115
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- Innopeutics Corporation
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