Clinical trials: Phase 1
Geographic Atrophy Secondary to Age-related Macular Degeneration
An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)
This is a clinical study to evaluate the safety, tolerability and efficacy of CTx001, administered via a single subretinal injection, for GA (secondary to AMD).
- Trial name
- Opti-GAIN (NCT07392255)
- Testing
- CTx001
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 75 people
- Sponsor
- Complement Therapeutics
Solid Tumor Cancer, Locally Advanced
AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a…
- Conditions
- Solid Tumor Cancer, Locally Advanced, Metastatic Solid Tumors, Lung Cancers
- Trial name
- NCT07038343
- Testing
- AVZO-1418, Combination Agent 1, Combination Agent 2
- Where
- 27 sites in United States, China
- Volunteers
- 480 people
- Sponsor
- Avenzo Therapeutics, Inc.
Prion Disease
PrP-targeting siRNA Safety & Mechanism Study
The purpose of this trial is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamic impact of PrP-siRNA in symptomatic prion disease patients and in pre-symptomatic adults at genetic risk for prion disease.
- Trial name
- PRiSM (NCT07444580)
- Testing
- PrP-siRNA
- Where
- 5 sites in United States
- Volunteers
- 45 people
- Sponsor
- Broad Institute of MIT and Harvard
Ropeginterferon, Alfa-2b
A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in MDS/AML With TP53 Mutations
To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS/AML with TP53 mutations.
- Conditions
- Ropeginterferon, Alfa-2b, Azacitidine, MDS/AML
- Trial name
- NCT07646821
- Testing
- ropeginterferon alfa- 2b, Azacitidine (AZA)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- M.D. Anderson Cancer Center
Nephropathic Cystinosis
DFT383 in Pediatric Participants With Nephropathic Cystinosis
An open-label, multi-center, phase I/II study to assess the safety, tolerability and efficacy of DFT383 in pediatric participants with nephropathic cystinosis, followed by a long-term extension phase.
- Trial name
- CYStem (NCT06910813)
- Testing
- DFT383
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Diffuse Large B Cell Lymphoma (DLBCL), Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
Axatilimab + CAR-T for High-Risk Lymphoma
Axatilimab + CAR-T in High-Risk Lymphoma
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL), Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma, High-grade B-cell Lymphoma (HGBCL), High-Grade B-Cell Lymphoma, Nos
- Trial name
- NCT07638982
- Testing
- Axatilimab
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Northside Hospital, Inc.
Hematologic Neoplasms
Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
Background: People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high.
- Trial name
- NCT05327023
- Testing
- donor lymphocyte infusion, Cyclophosphamide, Busulfan
- Where
- United States
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
Relapsed/Refractory Multiple Myeloma (MM)
Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma
A Phase 1a/1b Open-Label Study with Dose Escalation and Expansion Phases to Evaluate Safety and Preliminary Efficacy of Naïve HBI0101 CART Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma.
- Trial name
- NCT07333430
- Testing
- Naive HBI0101 CAR-T
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Hadassah Medical Organization
AML (Acute Myeloid Leukemia), BPDCN
CARCIK CD123/33 for Refractory/Relapsed AML and BPDCN in Children and Adults
The purpose of this phase I/II clinical trial is to test CARCIK-CD123/33 cells to treat patients with R/R AML/BPDCN, who have otherwise exhausted conventional treatment options.
- Trial name
- Dual CARCIK (NCT07877610)
- Testing
- CARCIK CD123/33 infusion
- Where
- 2 sites in Italy
- Volunteers
- 18 people
- Sponsor
- Fondazione Matilde Tettamanti Menotti De Marchi Onlus
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Background: Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is hyperthermic (heated) chemotherapy that washes the inside of the abdomen. CRS with HIPEC may help people with peritoneal carcinomatosis.
- Conditions
- Peritoneal Mesothelioma, Peritoneal Carcinomatosis, Ovarian Cancer, Gastrointestinal Cancer
- Trial name
- NCT04847063
- Testing
- Sodium Thiosulfate, 5-Fluorouracil, Oxaliplatin
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- National Cancer Institute (NCI)
Amyotrophic Lateral Sclerosis
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intrathecal Injection for ALS
This trial will study the safety and efficacy of intrathecal injection of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of amyotrophic lateral sclerosis
- Trial name
- NCT05003921
- Testing
- cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells
- Sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
Tumor, Solid
A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment
The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .
- Trial name
- NCT06987500
- Testing
- XNW29016
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Evopoint Biosciences Inc.
Neurofibromatosis Type 2
Doxycycline in Cutaneous Schwannoma (NF2)
In this research study the investigators want to learn more about an alternate, local treatment for skin schwannomas. Specifically, local doxycycline intra-tumoral injection will be performed as a potential treatment for…
- Trial name
- NCT05521048
- Testing
- Doxycycline Injection [Doxy]
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Massachusetts Eye and Ear Infirmary
Ovarian Cancer, HGSOC
Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Ovarian, fallopian tube, or primary peritoneal cancer, collectively referred to as ovarian cancer, remains the deadliest type of gynaecological cancer.
- Conditions
- Ovarian Cancer, HGSOC, HGS Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- Trial name
- OVACT (NCT07665515)
- Testing
- CryptiVax-1001
- Where
- 10 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Epitopea Ltd
Metastatic Castration-Resistant Prostate Cancer
A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.
- Trial name
- NCT06879041
- Testing
- AZD2287, AZD2275, AZD2284
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 136 people
- Sponsor
- AstraZeneca
Ductal Carcinoma in Situ
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12…
- Trial name
- NCT06218303
- Testing
- MUC1 Peptide Vaccine, Hiltonol®, Aromatase Inhibitor
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Finn, Olivera, PhD
Human Immunodeficiency Virus
Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy
Background: Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure. HIV can remain in the body, in infected cells called reservoirs.
- Trial name
- NCT06819176
- Testing
- Lenacapavir
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Subjects
A Phase I Study of the Interaction of D-2570 With Other Drugs in Healthy Adults
The primary purpose of this study is to characterize the drug-drug interaction profiles of D-2570 with midazolam, digoxin, rosuvastatin, metformin, itraconazole, rifampicin, and omeprazole.
- Trial name
- NCT07875842
- Testing
- Itraconazole, Rifampicin, Omeprazole
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Biliary Tract Cancer, Breast Cancer
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
- Conditions
- Biliary Tract Cancer, Breast Cancer, Cervical Cancer, Colon Cancer
- Trial name
- NCT06239194
- Testing
- MDX2001
- Where
- 6 sites in United States
- Volunteers
- 330 people
- Sponsor
- ModeX Therapeutics, An OPKO Health Company