Clinical trials: Dose Escalation and Safety
Neoplasms
First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors
An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory…
- Trial name
- NCT01881217
- Testing
- BAY1179470
- Where
- 8 sites in Japan, Singapore and 1 more
- Volunteers
- 35 people
- Sponsor
- Bayer
Androgenetic Alopecia
Evaluation of the Safety, Tolerability and Pharmacokinetics of AH-001 Following Topical Single and Multiple Ascending Dose Administration
The goal of this clinical trial is to assess the safety of the AH-001 drug substance at concentrations of 0.2%, 0.5%, 1%, and 2% in healthy volunteers and male subjects with androgenetic alopecia (AGA).
- Trial name
- NCT06927960
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- AnHorn Medicines Co. Ltd.
Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
In this study, adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676 and pembrolizumab following radiotherapy.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck
- Trial name
- NCT04879849
- Testing
- Pembrolizumab, TAK-676, Image-guided radiation therapy
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Takeda
Solid Tumor, Breast Cancer
A First-in-Human Study of SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors
This proposed Phase I clinical trial of SON-DP is an FIH, open-label, Phase Ia/Ib dose escalation and expansion study to evaluate the safety, tolerability, PK, and PD of SON-DP in participants with relapsed/refractory/intolerant…
- Conditions
- Solid Tumor, Breast Cancer, Pancreatic Cancer, Ovarian Cancer
- Trial name
- NCT05989724
- Testing
- SON-DP
- Where
- 5 sites in United States
- Volunteers
- 150 people
- Sponsor
- Qurgen Inc.
Advanced Unresectable Solid Tumors
Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China
M108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. The aim of this phase I study is to establish safety and Tolerability of different Dosage regimen in patients With Advanced Unresectable…
- Trial name
- NCT04894825
- Testing
- M108
- Where
- China
- Volunteers
- 152 people
- Sponsor
- FutureGen Biopharmaceutical (Beijing) Co., Ltd
Leukemia, Lymphoma
Safety Study Looking at the Use of a Natural Killer Cell Line Against Hematological Malignancies
The purpose of this study is to find out how many irradiated natural killer (NK) cells can be safely given to patients with cancer that has recurred after an autologous stem cell transplant, and to see what effects (good and bad)…
- Conditions
- Leukemia, Lymphoma, Myeloma, Hodgkin's Disease
- Trial name
- NCT00990717
- Testing
- NK-92 cells
- Where
- Canada
- Volunteers
- 8 people
- Sponsor
- University Health Network, Toronto
Pancreatic Cancer, Locally Advanced Pancreatic Cancer
Stereotactic Centralized Ablative Radiotherapy for Locally Advanced Pancreatic Cancer: A Single-Arm Phase I Safety and Feasibility Study
This is a single-arm, phase I clinical study designed to evaluate the safety and feasibility of SCART (Stereotactic Centralized Ablative Radiation Therapy) dose escalation in patients with locally advanced pancreatic cancer.
- Trial name
- SCART-P (NCT07173374)
- Testing
- SCART Dose Escalation Arm
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Shandong Cancer Hospital and Institute
Advanced or Metastatic Solid Tumors
A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors
TAK-188 is a new medicine that targets a protein called CCR8, which is found on the surface of certain cells (Tregs) inside tumors. These cells can weaken the body's ability to fight cancer.
- Trial name
- NCT07205718
- Testing
- TAK-188
- Where
- 15 sites in United States
- Volunteers
- 273 people
- Sponsor
- Takeda
Advanced Solid Tumors With MAPK Pathway Mutations
A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations
This first-in-human (FIH) study aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with…
- Trial name
- NCT05886920
- Testing
- D3S-002, D3S-001
- Where
- 18 sites in United States, Australia and 2 more
- Volunteers
- 67 people
- Sponsor
- D3 Bio (Wuxi) Co., Ltd
Osteoporosis
A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women
This is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACE-011 in healthy postmenopausal women.
- Trial name
- NCT00709540
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Malignant Solid Tumor, Oncology
A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies
Part A: The purpose of this part is to assess the safety of GEH200520 and GEH200521 (18F) when administered to patients with solid cancer.
- Trial name
- NCT05629689
- Testing
- GEH200520 Injection / GEH200521 (18F) Injection - Part A, Dynamic and Static - PET/CT scan, GEH200520 Injection / GEH200521 (18F) Injection - Part B
- Where
- 2 sites in Netherlands
- Volunteers
- 19 people
- Sponsor
- GE Healthcare
Leprosy
Phase 1 LEP-F1 + GLA-SE Vaccine Trial in Healthy Adult Volunteers
The purpose of this study is to compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of leprosy.
- Trial name
- NCT03302897
- Testing
- LEP-F1 + GLA-SE
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Solid Tumor, Gastric Cancer
SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors
A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of SON-DP in Subjects with Advanced Solid Tumors
- Conditions
- Solid Tumor, Gastric Cancer, Liver Cancer
- Trial name
- NCT06873659
- Testing
- SON-DP
- Where
- 11 sites in China
- Volunteers
- 96 people
- Sponsor
- Qurgen Inc.
Solid Tumors
A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated
This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful and for whom no other treatment options exist can join the study.
- Trial name
- NCT05327946
- Testing
- BI 770371, ezabenlimab
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 42 people
- Sponsor
- Boehringer Ingelheim
Osteogenesis Imperfecta
Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta
This is a randomized, open label intra-patient dose escalation study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis imperfecta (OI).
- Trial name
- NCT01417091
- Testing
- BPS804
- Where
- 6 sites in United States, Belgium and 2 more
- Volunteers
- 10 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Advanced Solid Tumors
A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors
This is a phase I/II study to evaluate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJB001 capsules in patients with advanced solid tumors, including…
- Trial name
- NCT05773820
- Testing
- WJB001
- Where
- 11 sites in China
- Volunteers
- 63 people
- Sponsor
- Wigen Biomedicine Technology (Shanghai) Co., Ltd.
Chronic Hepatitis C Virus Infection
Safety, Tolerability and Efficacy of XTL 2125 in HCV-Infected Patients Who Are Interferon-Alpha Non-Responders or Relapsers
The study will be a randomized, double blind, placebo controlled, dose rising study in Interferon alpha (IFN-alpha) non-responder HCV infected patients or HCV patients who have relapsed following IFN-alpha therapy.
- Trial name
- NCT00255359
- Testing
- XTL-2125
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Hadassah Medical Organization
Advanced Malignancies
Safety Study of Oral MGCD265 Administered With Interruption to Subjects With Advanced Malignancies
In this study, MGCD265, a new anticancer drug under investigation, is given daily on a 7 days on / 7 days off schedule to patients with advanced malignancies to study its safety profile.
- Trial name
- NCT00679133
- Testing
- MGCD265
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mirati Therapeutics Inc.
Advanced Solid Tumor
A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor
This study is a phase I/II study of single drug TJ011133 and Toripalimab combine treatment forAdvanced solid tumor. This study include two stages. First stage is dose escalation and second stage is dose extension.
- Trial name
- NCT05148533
- Testing
- TJ1133 Injection
- Where
- 22 sites in China
- Volunteers
- 7 people
- Sponsor
- TJ Biopharma Co., Ltd.
Neoplasms
A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-0482-001)
This is a 2 part study. Part 1 is a dose escalation to determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) dose of MK-0482 administered as monotherapy and in combination with…
- Trial name
- NCT03918278
- Testing
- MK-0482, pembrolizumab, Paclitaxel
- Where
- 16 sites in United States, Australia and 6 more
- Volunteers
- 222 people
- Sponsor
- Merck Sharp & Dohme LLC
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