Clinical trials: Phase 1b, open to volunteers
Triple Negative Breast Cancer, HER2-negative Breast Cancer
A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
A phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas
- Conditions
- Triple Negative Breast Cancer, HER2-negative Breast Cancer, Non Small Cell Lung Cancer, Cervical Cancer
- Trial name
- NCT06999187
- Testing
- DR-0202
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Dren Bio
NF1 Mutation, Neurofibroma Plexiform
PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas
The main purpose of this clinical trial is to test PAS-004 in people with at least one symptomatic plexiform neurofibroma due to Neurofibromatosis Type 1 (NF1).
- Conditions
- NF1 Mutation, Neurofibroma Plexiform, Neurofibroma, Plexiform, Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs)
- Trial name
- NCT06961565
- Testing
- PAS-004 Tablets, PAS-004 Capsule
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 56 people
- Sponsor
- Pasithea Therapeutics Corp.
Elevated Blood Pressure, Hypertension
HJB647 Phase 1b Study in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacokinetics, and pharmacodynamics of HJB647 following single dose administration in Japanese healthy participants with elevated blood…
- Trial name
- NCT07644364
- Testing
- HJB647
- Where
- Japan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
High Grade Serous Adenocarcinoma of Ovary, Fallopian Tube Cancer
A Study of Sovilnesib in Subjects With Ovarian Cancer
This is a phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of sovilnesib at different dose levels to establish the optimal dose of sovilnesib in subjects with selected advanced…
- Conditions
- High Grade Serous Adenocarcinoma of Ovary, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Chromosomal Instability
- Trial name
- NCT06084416
- Testing
- Sovilnesib
- Where
- 11 sites in United States
- Volunteers
- 150 people
- Sponsor
- Volastra Therapeutics, Inc.
Sarcoma, Soft-tissue, Sarcoma
BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas
A Phase 1b, non-randomized, single-institution trial designed to assess the safety, tolerability and the highest dose with acceptable toxicity (RP2D) of BOLD-100 in combination with doxorubicin in patients diagnosed with advanced…
- Conditions
- Sarcoma, Soft-tissue, Sarcoma, Sarcoma,Soft Tissue, Sarcomas
- Trial name
- NCT07027423
- Testing
- BOLD-100, Doxorubicin 75 mg/m^2
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- University Health Network, Toronto
CD19 Positive, B-ALL
Metabolically Fit CD19 CAR T Cells With CD34 Selection Markers in Adults With CD19-Positive B-Cell Acute Lymphocytic Leukemia
The goal of this trial is to determine safe dosing of CD19-CD34t metabolically programmed CAR-T cell therapy in adult patients with CD19-positive B-cell acute lymphocytic leukemia (B-ALL).
- Conditions
- CD19 Positive, B-ALL, B-cell Acute Lymphocytic Leukemia, Chimeric Antigen Receptor T-cell
- Trial name
- NCT07896213
- Testing
- Fludarabine, Cyclophosphamide, Levetiracetam
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Medical University of South Carolina
Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC)
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical ([225Ac]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors…
- Conditions
- Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer
- Trial name
- NCT07020117
- Testing
- [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)
- Where
- 14 sites in United States
- Volunteers
- 150 people
- Sponsor
- Aktis Oncology, Inc.
Malignant Germ Cell Tumor, Lung Adenocarcinoma
DBC-664 in Adult Patients With Solid Tumors
DBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of DBC-664 in patients with endometrial cancer, ovarian…
- Conditions
- Malignant Germ Cell Tumor, Lung Adenocarcinoma, Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma, Urothelial Carcinoma
- Trial name
- NCT07705035
- Testing
- DBC-664
- Where
- 7 sites in United States
- Volunteers
- 210 people
- Sponsor
- Duboce Biopharmaceuticals, Inc.
Solid Tumor, Epithelial Ovarian Cancer
A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer
This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.
- Conditions
- Solid Tumor, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Trial name
- MUIR (NCT04516447)
- Testing
- Azenosertib, Carboplatin, Pegylated liposomal doxorubicin
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 172 people
- Sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Age-Related Macular Degeneration
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
Age-related macular degeneration (AMD) is an eye disease which causes people to lose their sharp central vision over time. Aging damages the macula, which is in the middle of the retina - the light-sensitive part at the back of…
- Trial name
- NCT03178149
- Testing
- ASP7317, tacrolimus, trimethoprim-sulfamethoxazole
- Where
- 20 sites in United States
- Volunteers
- 42 people
- Sponsor
- Astellas Institute for Regenerative Medicine
ALS (Amyotrophic Lateral Sclerosis)
Safety and Tolerability Study of CTx1000 In Participants With Amyotrophic Lateral Sclerosis
This clinical study is in participants with Amyotrophic Lateral Sclerosis and is designed to evaluate the safety and tolerability of the gene therapy CTx1000.
- Trial name
- KOANEWA (NCT07401121)
- Testing
- AAV9 Gene therapy
- Where
- Australia
- Volunteers
- 15 people
- Sponsor
- Celosia Therapeutics Pty Ltd
B-cell Malignancy, Chronic Lymphocytic Leukemia
AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma
This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 (docirbrutinib) in patients with CLL/SLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.
- Conditions
- B-cell Malignancy, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Waldenstrom Macroglobulinemia
- Trial name
- NCT05602363
- Testing
- Docirbrutinib
- Where
- 13 sites in United States
- Volunteers
- 120 people
- Sponsor
- Carna Biosciences, Inc.
Ewing Sarcoma
Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)
The main objectives of this trial are to determine the recommended dose for expansion of xaluritamig (dose confirmation part only) and to determine the safety and tolerability of xaluritamig in adult, adolescent and pediatric…
- Trial name
- NCT07297979
- Testing
- Xaluritamig
- Where
- 13 sites in United States, Australia
- Volunteers
- 50 people
- Sponsor
- Amgen
Anaplastic Thyroid Cancer, Thyroid Cancer
XL092 and Cemiplimab in BRAF WT Thyroid Cancer
This multicenter study examines the safety and feasibility of the combination of neoadjuvant XL092 and cemiplimab prior to surgical resection in participants with wild-type (WT) anaplastic thyroid cancer (ATC) that has a BRAF…
- Conditions
- Anaplastic Thyroid Cancer, Thyroid Cancer, BRAF Mutation-Related Tumors
- Trial name
- NEO-COMBATXL (NCT06902376)
- Testing
- Cemiplimab, XL092
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Amyotrophic Lateral Sclerosis (ALS)
A Clinical Trial to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis.
The purpose of this trial is to learn about the effects of NB-4746 compared with placebo in people with amyotrophic lateral sclerosis.
- Trial name
- NCT07369076
- Testing
- NB-4746 High dose, NB-4746 Low dose, NB-4746 (Dose TBD)
- Where
- 12 sites in Australia, Canada and 2 more
- Volunteers
- 80 people
- Sponsor
- Nura Bio
Advanced Malignancies and Hepatic Impairment
Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment
The primary purpose of this study is to evaluate the impact of hepatic function on the pharmacokinetic (PK) profile of pelabresib in participants with advanced malignancies who have either hepatic impairment (HI) or normal liver…
- Trial name
- NCT07422610
- Testing
- pelabresib
- Where
- 10 sites in France, Italy and 2 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia
A Phase 1b Study of Lonitoclax + Azacitidine in Acute Myeloid Leukemia Patients
This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory Acute Myeloid Leukemia patients.
- Trial name
- NCT07303660
- Testing
- ZE50-0134, Azacitidine Days 1-7, ZE 50-0134
- Where
- 6 sites in Russia, Uzbekistan
- Volunteers
- 66 people
- Sponsor
- Lomond Therapeutics Holdings, Inc.
Sepsis, Community Acquired Pneumonia (CAP)
OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis
OPT101-100-40 is a multicenter, randomized, placebo-controlled, multiple-ascending-dose, sequential-group, investigator- and participant-blinded, sponsor-unblinded, study of OPT101 vs placebo when administered for up to 4 days to…
- Trial name
- NCT06669403
- Testing
- OPT101
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Op-T LLC
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)
Lymphoma, B-Cell
Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
The goal of this clinical trial is to learn if BMT-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas.
- Trial name
- NCT06792734
- Testing
- BTM-3566
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Bantam Pharmaceuticals