Clinical trials: Phase I
Breast Cancer, Breast Neoplasms
A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)
This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors.
- Conditions
- Breast Cancer, Breast Neoplasms, Colon Cancer, Colonic Cancer
- Trial name
- NCT00600496
- Testing
- AZD6244, Dacarbazine, Erlotinib
- Where
- 4 sites in United States
- Volunteers
- 140 people
- Sponsor
- AstraZeneca
Renal Impairment
A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal…
- Trial name
- NCT06742762
- Testing
- AZD5004
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers
This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.
- Trial name
- NCT01731327
- Testing
- tofacitinib modified-release (MR) formulation
- Where
- Singapore
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Pfizer
Neoplasms
Phase I Dose Finding Study of SSR97225 Given in Patients With Refractory Cancer
The purpose of this study is to determine the maximally tolerated dose and the dose limiting toxicity of this antimitotic, tubulin binding investigational drug for those patients who have failed standard anticancer treatments.
- Trial name
- NCT00547261
- Testing
- SSR97225
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Sanofi
Healthy
A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male Subjects
This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and tolerability of a single subcutaneous administration…
- Trial name
- NCT02146261
- Testing
- E6011
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Cancer
Clinical Study of WT2725 in Patients With Advanced Malignancies
This clinical study is designed to evaluate the safety, immunogenicity and antitumor activity of WT2725. WT2725 will be administered to patients with advanced malignancies known to overexpress WT1
- Trial name
- NCT01621542
- Testing
- WT2725
- Where
- 6 sites in United States
- Volunteers
- 64 people
- Sponsor
- Sumitomo Pharma America, Inc.
Healthy Volunteer, Muscular Dystrophies
Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers
This is a Phase 1 2-part, single-center, open-label study in healthy male volunteers. Part A will assess the absorption, metabolism, excretion, and pharmacokinetics of one oral dose of radiolabeled EDG-5506.
- Conditions
- Healthy Volunteer, Muscular Dystrophies, Muscular Disorders, Atrophic, Muscular Diseases
- Trial name
- NCT05730842
- Testing
- EDG-5506 Tablet, Radiolabeled EDG-5506 Suspension, Radiolabeled EDG-5506 Intravenous
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Edgewise Therapeutics, Inc.
Acute Myeloid Leukemia
Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
The primary objective is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid leukemia (AML).
- Trial name
- NCT00279773
- Testing
- TKI258
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Colorectal Cancer, Non-Small Cell Lung Cancer
A Phase 1 Study of IM-1340 in Participants With Advanced Cancer
This study will test the safety and effectiveness of a drug called IM-1340 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with…
- Conditions
- Colorectal Cancer, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Neuroendocrine Neoplasm
- Trial name
- NCT07890246
- Testing
- IM-1340
- Volunteers
- 200 people
- Sponsor
- Immunome, Inc.
Advanced Cancer, Ovarian Cancer
COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced…
- Conditions
- Advanced Cancer, Ovarian Cancer, Lung Cancer, Colon Cancer
- Trial name
- NCT04354246
- Testing
- Dose escalation: COM902 monotherapy., Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE), Cohort expansion: COM902 (RDFE) monotherapy.
- Where
- 9 sites in United States
- Volunteers
- 94 people
- Sponsor
- Compugen Ltd
Relapsing Multiple Sclerosis (RMS)
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV…
- Trial name
- ULTIMATE 1 (NCT03277261)
- Testing
- Ublituximab, Teriflunomide
- Where
- 14 sites in United States
- Volunteers
- 549 people
- Sponsor
- TG Therapeutics, Inc.
Advanced Cancer
A Dose-Escalation Study for Patients With Advanced Cancer
This study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).
- Trial name
- NCT01214642
- Testing
- pegfilgrastim, LY2523355
- Where
- 2 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eli Lilly and Company
Healthy Adults
Phase 1a Single Ascending Dose Study of MIB-725 in Healthy Adults
This is a single center, open label (i.e. participants and study staff will not be masked to the intervention) single ascending dose study to evaluate the safety, tolerability, pharmaokinetics and pharmacodynamics of MIB-725 in…
- Trial name
- NCT06815991
- Testing
- MIB-725
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Metro International Biotech, LLC
Prostate Cancer
A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer
Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of testosterone in the body. One of the side effects of hormone therapy is hot flashes.
- Trial name
- NCT07783282
- Testing
- fezolinetant, enzalutamide, apalutamide
- Where
- Bulgaria
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Seasonal Influenza
Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum
the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule.
- Trial name
- ICC H1 (NCT01761123)
- Testing
- VXA-A1.1
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Vaxart
Tuberculosis
Study to Evaluate the Tolerability and Immunogenicity of Nyaditum Resae ® Probiotic Administered to Pediatric Population in Contact With Tuberculosis With or Without Latent Tuberculosis Infection
This is a doble-blind, masked, compared with placebo clinical trial in pediatric population in contact with tuberculosis with or without tuberculosis infection.
- Trial name
- NCT02581579
- Testing
- Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis
- Where
- 3 sites in Spain
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Manresana de Micobacteriologia, SL
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
A Phase II Trial for MOR Antagonism With Axelopran to Enhance Immunotherapy in Head and Neck Cancer
This Phase 2, open-label, multicenter study will evaluate the safety and preliminary efficacy of axelopran in combination with pembrolizumab in patients with PD-L1 positive recurrent or metastatic head and neck squamous cell…
- Trial name
- MORALE-HN01 (NCT07662720)
- Testing
- axelopran, Pembolizumab
- Volunteers
- 18 people
- Sponsor
- Glycyx Therapeutics
Osteosarcoma
A Study of Azenosertib (ZN-c3) in Combination With Gemcitabine in Subjects With Osteosarcoma
This is a phase 1/2 study of azenosertib (ZN-c3) in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.
- Trial name
- NCT04833582
- Testing
- Azenosertib, Gemcitabine
- Where
- 17 sites in United States, France
- Volunteers
- 31 people
- Sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Chronic Lymphocytic Leukemia, Multiple Myeloma
Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML
A phase 1, first-in-human trial to evaluate the safety and tolerability of LAVA-051 in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), or Acute Myeloid Leukemia (AML).
- Conditions
- Chronic Lymphocytic Leukemia, Multiple Myeloma, Acute Myeloid Leukemia
- Trial name
- NCT04887259
- Testing
- LAVA-051, Interleukin 2
- Where
- 14 sites in United States, France and 2 more
- Volunteers
- 16 people
- Sponsor
- Lava Therapeutics
Healthy Participants
Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants
The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.
- Trial name
- NCT06577259
- Testing
- BMS-986435
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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