Clinical trials: Early Phase 1, open to volunteers
Duchenne Muscular Dystrophy (DMD)
Safety and Dystrophin Expression of SPOT-03 in Duchenne Muscular Dystrophy (DMD) Patients
The primary objective of this study is to evaluate the safety and tolerability of SPOT-03 administered by intravenous (IV) infusion to DMD patients.
- Trial name
- NCT07188012
- Testing
- SPOT-03
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Shanghai Siponuoyin Biotechnology Co Ltd
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Truway Diagnostic Tools in Primary Care
This study evaluates the effectiveness of Truway Health-sourced portable diagnostic devices, including ultrasound and blood glucose monitors, in early detection of chronic conditions in outpatient primary care settings.
- Conditions
- Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, Hypertension, Cardiovascular Disease Acute
- Trial name
- TruDxPC (NCT07209527)
- Testing
- Truway Portable Ultrasound Device, Truway Blood Glucose Monitor, Standard Oral Hypoglycemic Agent
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Truway Health, Inc.
Relapsed/Refractory Hematologic Malignancies
Dose-Escalation/Expansion Study of iMagic in Relapsed/Refractory Hematologic Malignancies
This is an investigator-initiated, single-center, dose-escalation and dose-expansion early-phase clinical study to evaluate the safety and efficacy of iMagic Injection in participants with hematologic malignancies.
- Trial name
- NCT07802756
- Testing
- iMagic Injection (IMV101), iMagic Injection (IMV102)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Suzhou Immunofoco Biotechnology Co., Ltd
PDL1 Gene Mutation, Non Small Cell Lung Cancer
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
This is a Phase 0/1, First-in-Human (FIH), study to evaluate safety, tolerability of 177Lu-RAD204 in participants with selected solid tumors, and to determine the MTD and/or recommended dose for future exploration.
- Conditions
- PDL1 Gene Mutation, Non Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), TNBC, Triple Negative Breast Cancer
- Trial name
- NCT06305962
- Testing
- 177Lu-RAD204
- Where
- 6 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Radiopharm Theranostics, Ltd
Spinal Muscular Atrophy (SMA)
SPX-01 Gene Therapy in Pediatric Patients With Spinal Muscular Atrophy Type 1 (RISE)
The goal of this clinical trial is to learn about the safety, and tolerability of giving an experimental gene therapy called SPX-01 to an infant with spinal muscular atrophy (SMA) type 1.
- Trial name
- NCT07903376
- Testing
- SPX-01
- Where
- Iran
- Volunteers
- 1 people
- Sponsor
- Exir Gene Pharmed
Hyperglycemias, Prediabetes
Efficacy of the pA1c®HI Postbiotic in Metabolic Regulation in Healthy Individuals With Hyperglycemia
This study will evaluate the effects of pA1c®HI, a heat-inactivated postbiotic derived from the bacterium Pediococcus acidilactici, on blood glucose regulation and other aspects of metabolic health in adults with elevated blood…
- Trial name
- CR2027 (NCT07903870)
- Testing
- Postbiotic
- Where
- Spain
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Genbioma Aplicaciones SL
Parkinson's Disease (PD), Multiple System Atrophy (MSA)
[18F]ACI-15916 PET in α-synucleinopathies
The goal of this clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein α-synuclein [involved in some diseases such as Parkinson's disease, Lewy body dementia and Multiple…
- Conditions
- Parkinson's Disease (PD), Multiple System Atrophy (MSA), Dementia With Lewy Bodies (DLB)
- Trial name
- NCT06891703
- Testing
- [18F]ACI-15916
- Where
- Sweden
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- AC Immune SA
Air Trapping, Emphysema
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
The objective of this study is to provide a regional, mechanistic characterization of pulmonary ventilation changes following treatment with the Apreo BREATHE System, using hyperpolarized ¹²⁹Xe MRI, in BREATHE-3 participants.
- Conditions
- Air Trapping, Emphysema, Hyperinflation
- Trial name
- BREATHE-Xe (NCT07896902)
- Testing
- Hyperpolarized Xenon MRI, Apreo BREATHE Airway Scaffold
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Apreo Health, Inc.
TCR-T Cells, Refractory Solid Tumors
KSX01-TCRT Injection Project in Solid Tumors
1) Safety and efficacy of TCR-T cells in subjects with refractory/relapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.
- Conditions
- TCR-T Cells, Refractory Solid Tumors, Relapsed Solid Tumors
- Trial name
- NCT05811975
- Testing
- KSX01-TCRT injection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- TCRx Therapeutics Co.Ltd
Small Cell Lung Cancer ( SCLC ), CAR-T Cell Therapy
TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive Relapsed/Refractory primary small…
- Trial name
- NCT07246304
- Testing
- TC-D101 CAR-T
- Where
- China
- Volunteers
- 24 people
- Sponsor
- TCRCure Biopharma Ltd.
Solid Tumor
KSH01-R02-101 Solid Tumors
1. . safety and tolerance 2. . objective response rate
- Trial name
- NCT05580796
- Testing
- KSH01 injection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- TCRx Therapeutics Co.Ltd
TCR-T Cells, Refractory Solid Tumors
KSH01-TCRT Solid Tumors
1) Safety and efficacy of TCR-T cells in subjects with refractory/relapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.
- Conditions
- TCR-T Cells, Refractory Solid Tumors, Relapsed Solid Tumors
- Trial name
- KSH01-TCRT (NCT05539833)
- Testing
- KSH01 injection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- TCRx Therapeutics Co.Ltd
Influenza
A Trial of RLX-2508-102 in Healthy Volunteers
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose and multiple dose of RLX-2508 in healthy participants across different ethnic backgrounds.
- Trial name
- NCT07873671
- Testing
- RLX-2508
- Where
- 3 sites in Australia
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.
Metastatic Urothelial Carcinoma, Breast Cancer
Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.
- Conditions
- Metastatic Urothelial Carcinoma, Breast Cancer, TNBC - Triple-Negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT07671092
- Testing
- RYZ211/212
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 40 people
- Sponsor
- RayzeBio, Inc.
Metastatic Clear Cell Renal Cell Carcinoma
Imaging Study in Metastatic Clear Cell RCC.
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in Subjects with Metastatic Clear Cell Renal Cell Cancer (RCC).
- Trial name
- NCT07671417
- Testing
- RYZ512
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 10 people
- Sponsor
- RayzeBio, Inc.
Gastric Cancer (GC), Colorectal Cancer
Safety and Efficacy of NK510 to Treat Gastric Cancer and Colorectal Cancer
This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer and colorectal cancer.NK510 will be administered by intravenous infusion for systemic therapy and…
- Trial name
- NCT07166263
- Testing
- NK510
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
Hepatocellular Carcinoma (HCC), Ovarian Cancer
NK521 in the Treatment of Advanced Solid Tumors
Eligible subjects with advanced hepatocellular carcinoma and ovarian cancer will be divided into two treatment groups based on the volume of ascites.
- Conditions
- Hepatocellular Carcinoma (HCC), Ovarian Cancer, Malignant Ascites
- Trial name
- NCT07657416
- Testing
- NK521 Cell Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
Solid Tumors, Metastatic Cancer
IL-15 Enhanced NK Cell Therapy for Solid Tumors
A single-arm, Phase 1 study evaluating safety, tolerability, and preliminary efficacy of IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.
- Trial name
- NCT07621471
- Testing
- IL-15 enhanced engineered NK cells
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Genovn Therapeutics (Suzhou) Co., Ltd.
Atherosclerotic Cardiovascular Disease, Acute Coronary Syndromes
Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Followed by an Open-label Patient Cohort
The goal of this clinical trial is to learn if UDP-003 is safe in healthy human participants and patients, assess the pharmacokinetics (PK)/pharmacodynamics (PD) of UDP-003 in healthy human participants and patients and its…
- Trial name
- CTx-001 (NCT06813339)
- Testing
- UDP-003
- Where
- 3 sites in Australia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Cyclarity Therapeutics, Inc.
HER2 Gene Mutation, Advanced Solid Tumors
HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
This is a first-in-human, Phase 0/1, open-label study of177Lu-RAD202 to determine the recommended dose(s) for future exploration of 177Lu-RAD202 in participants with HER2 expressing advanced solid tumours.
- Trial name
- RAD202 (NCT06824155)
- Testing
- 177Lu-RAD202
- Where
- 5 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Radiopharm Theranostics, Ltd