Clinical trials: Dose Escalation and Safety
Advanced Solid Tumors
HW071021 Monotherapy in Patients With Advanced Solid Tumors
This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 monotherapy in patients with advanced solid tumors.
- Trial name
- NCT06882135
- Testing
- HW071021 Tablets
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
High-risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (CMML)
A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias
Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed/refractory AML, HR-MDS, CMML, and CML. Participants aged ≥ 12 years are planned to be enrolled.
- Conditions
- High-risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (CMML), AML - Acute Myeloid Leukemia, Chronic Myeloid Leukemia
- Trial name
- CROSSCHECK-001 (NCT06994676)
- Testing
- CBX-250
- Where
- 11 sites in United States
- Volunteers
- 72 people
- Sponsor
- Crossbow Therapeutics, Inc.
Advanced Melanoma
A Study to Evaluate the Safety and Tolerability of Using the SHR-1210 in Patients With Advanced Melanoma
This is an open-label, single center, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 (camrelizumab) in patients with advanced melanoma with disease progression after standard…
- Trial name
- NCT02738489
- Testing
- SHR-1210
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Osteoarthritis, Knee
Mesenchymal Stem Cells for The Treatment of Knee Osteoarthritis (KOA).
The clinical study with UMC119-06-05 is designed to investigate the safety in patients with mild to moderate knee osteoarthritis (KOA).
- Trial name
- NCT04893174
- Testing
- UMC119-06-05, Hyaluronic acid
- Where
- Taiwan
- Volunteers
- 6 people
- Sponsor
- Meridigen Biotech Co., Ltd.
Solid Tumors
An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or…
- Trial name
- NCT02598960
- Testing
- BMS-986156, Nivolumab
- Where
- 27 sites in United States, Australia and 8 more
- Volunteers
- 295 people
- Sponsor
- Bristol-Myers Squibb
Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis
A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients
The purpose of this Phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous AMB-05X in the treatment of subjects with TGCT.
- Conditions
- Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, TGCT, PVNS - Pigmented Villonodular Synovitis
- Trial name
- NCT04938180
- Testing
- AMB-05X
- Where
- 5 sites in Hungary, Poland and 1 more
- Volunteers
- 4 people
- Sponsor
- AmMax Bio, Inc.
Advanced Cancer
Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors
This study evaluated the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-A317 in participants with advanced tumors.
- Trial name
- NCT02407990
- Testing
- BGB-A317
- Where
- 27 sites in United States, Australia and 3 more
- Volunteers
- 451 people
- Sponsor
- BeiGene
Liver Metastases
AvidinOX + [177Lu]DOTA-biotin (or 177Lu-ST2210) Complex in Patients With Liver Metastases From Colorectal Cancer
The purpose of the study is to assess a new treatment for patients with liver tumor metastases from colorectal cancer. The treatment has never been used in humans before.
- Trial name
- NCT02053324
- Testing
- AvidinOX/ST2210
- Where
- 4 sites in Austria, Italy
- Volunteers
- 14 people
- Sponsor
- Alfasigma S.p.A.
Prevention of HIV Infection, HIV Antibodies
Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to Healthy Adults
Background: Antibodies help the body fight infection. VRC01LS is an antibody directed against HIV virus. HIV attacks the immune system. In animals, VRC01LS inactivated many types of HIV viruses.
- Conditions
- Prevention of HIV Infection, HIV Antibodies, Monoclonal Antibody, Human, Neutralizing Antibody
- Trial name
- NCT02599896
- Testing
- VRC-HIVMAB080-00-AB (VRC01LS), VRC-HIVMAB060-00-AB (VRC01)
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malignant Melanoma
A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma.
- Trial name
- NCT01271803
- Testing
- Cobimetinib, vemurafenib
- Where
- 10 sites in United States, Australia
- Volunteers
- 131 people
- Sponsor
- Hoffmann-La Roche
Advanced Solid Tumor
Study of D3L-002 in Subjects With Advanced Solid Tumors
This is a first-in-human, multicenter, open-label, single-arm, dose-escalation Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of D3L-002…
- Trial name
- NCT07667842
- Testing
- D3L-002
- Where
- 6 sites in Australia, South Korea
- Volunteers
- 24 people
- Sponsor
- D3 Bio (Wuxi) Co., Ltd
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants
To Evaluate the Safety and Tolerability, Pharmacokinetics and Biomarker of GenSci161 in a Randomized, Double-blind, Placebo-controlled Study in Healthy Adult Participants.
- Trial name
- NCT07476586
- Testing
- GenSci161
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Inflammatory Bowel Diseases
Pharmacokinetics and Pharmacodynamics Clinical Study of VC005 Tablets in Healthy Subjects
This clinical trial consists of two parts：1. a randomized, double-blind, single-center, placebo-controlled, dose-escalation PK study; 2. food effects and drug metabolism transformation study.
- Trial name
- NCT05138770
- Testing
- VC005 Tablets, VC005 Tablets food effects group
- Where
- China
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
Solid Tumor, Adult
A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy
The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity.
- Trial name
- NCT05435339
- Testing
- GEN1053
- Where
- 5 sites in United States, Spain
- Volunteers
- 31 people
- Sponsor
- Genmab
Advanced Solid Tumors Cancer
A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors
An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.
- Trial name
- NCT03311477
- Testing
- ABBV-399
- Where
- 2 sites in Japan
- Volunteers
- 9 people
- Sponsor
- AbbVie
Neoplasms, Medication Toxicity
Study of Orally-Administered AMXT 1501 Dicaprate in Normal Healthy Volunteers
This is a Phase 1 study, which will assess the safety, PK, and pharmacodynamics (PD) of orally-administered AMXT 1501 dicaprate in normal healthy male volunteers.
- Conditions
- Neoplasms, Medication Toxicity, Tolerance
- Trial name
- NCT03077477
- Testing
- AMXT 1501
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aminex Therapeutics, Inc.
Limb-Girdle Muscular Dystrophies, Facioscapulohumeral Muscular Dystrophy
Evaluate Safety and Biological Activity of ATYR1940 in Participants With Limb Girdle Muscular Dystrophy 2B (LGMD2B) and Facioscapulohumeral Muscular Dystrophy (FSHD)
The purpose of this study is to assess the safety and biological activity of ATYR1940 in participants with LGMD2B and FSHD.
- Trial name
- FSHD (NCT02579239)
- Testing
- ATYR1940
- Where
- 6 sites in United States, Denmark and 1 more
- Volunteers
- 18 people
- Sponsor
- aTyr Pharma, Inc.
Malignant Solid Tumor
Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy
The goal of this trial is to learn about the antibody GEN1055 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with…
- Trial name
- NCT06391775
- Testing
- GEN1055, Pembrolizumab, Standard Chemotherapy
- Where
- 4 sites in United States, Spain
- Volunteers
- 21 people
- Sponsor
- Genmab
Chronic Lymphocytic Leukemia, Leukemia, B-Cell, Chronic
A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or…
- Trial name
- NCT00419250
- Testing
- lenalidomide
- Where
- 35 sites in United States, Canada and 5 more
- Volunteers
- 52 people
- Sponsor
- Celgene
Chronic Myeloid Leukemia, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Study of XL228 in Subjects With Chronic Myeloid Leukemia or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia
The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how often it should be taken, and how well people with leukemia tolerate XL228.
- Trial name
- NCT00464113
- Testing
- XL228
- Where
- 6 sites in United States
- Volunteers
- 49 people
- Sponsor
- Exelixis
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