Clinical trials: Dose Escalation and Safety
Overweight, Healthy
A Study of LY3541105 in Healthy and Overweight Participants
The main purpose of this study is to evaluate the safety and tolerability of LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it…
- Trial name
- NCT05380323
- Testing
- LY3541105
- Where
- 2 sites in United States
- Volunteers
- 206 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Partial Epilepsies
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg…
- Trial name
- SELF (NCT01235403)
- Testing
- Lacosamide
- Where
- 32 sites in France
- Volunteers
- 100 people
- Sponsor
- UCB Pharma
Advanced Solid Tumors, Metastatic Solid Tumors
A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors
This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.
- Trial name
- NCT03854227
- Testing
- PF-06939999 dose escalation, PF-06939999 monotherapy, PF-06939999 in combination with docetaxel
- Where
- 22 sites in United States
- Volunteers
- 54 people
- Sponsor
- Pfizer
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07318805
- Testing
- PF-08032562, Fulvestrant, Cetuximab
- Where
- 13 sites in United States
- Volunteers
- 260 people
- Sponsor
- Pfizer
Cocaine Use Disorder, Tobacco Use Disorder
Single and Multiple Rising Dose Study of Safety and PK of Metyrapone/Oxazepam Combination (EMB-001)
This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in otherwise healthy adults who are regular cigarette smokers.
- Trial name
- NCT02406066
- Testing
- metyrapone & oxazepam
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Embera NeuroTherapeutics, Inc.
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal…
- Trial name
- NCT03482453
- Testing
- TAK-788
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Non-muscle Invasive Bladder Cancer, NMIBC
A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with…
- Conditions
- Non-muscle Invasive Bladder Cancer, NMIBC, Carcinoma in Situ of Bladder, Bladder Cancer
- Trial name
- NCT05375903
- Testing
- UGN-301, UGN-201, Gemcitabine
- Where
- 13 sites in United States, Italy and 1 more
- Volunteers
- 51 people
- Sponsor
- UroGen Pharma Ltd.
Interstitial Cystitis
Safety Study of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain Syndrome
The purpose of this study is to determine the safety and pharmacokinetics of TTI-1612 in women with interstitial cystitis/bladder pain syndrome.
- Trial name
- NCT01559961
- Testing
- TTI-1612
- Where
- 4 sites in Canada
- Volunteers
- 28 people
- Sponsor
- Trillium Therapeutics Inc.
CNS Lymphoma
[90Y]Y-PTT Endoradiotherapy in CNS Lymphoma Patients
This will be an open-label, single-arm, national phase 1/2 therapeutic study to evaluate the safety, tolerability, and preliminary efficacy of [90Y]Y-PentixaTher ([90Y]Y-PTT) for the treatment of recurrent or refractory primary…
- Trial name
- NCT06132737
- Testing
- [90Y]Y-PentixaTher
- Where
- 2 sites in Germany
- Volunteers
- 15 people
- Sponsor
- Pentixapharm AG
HR+/HER2- Breast Cancer
Abemaciclib Dose Escalation in Early High-Risk Breast Cancer Adjuvant Therapy
Abemaciclib combined with endocrine therapy has become one of the important adjuvant treatment regimens for patients with HR+/HER2- high-risk early breast cancer.
- Trial name
- ADES (NCT07599137)
- Testing
- Dose escalation
- Volunteers
- 86 people
- Sponsor
- Peking University Cancer Hospital & Institute
Relapsed or Refractory Acute Myeloid Leukemia (AML), Untreated AML
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation.
- Conditions
- Relapsed or Refractory Acute Myeloid Leukemia (AML), Untreated AML, Other IDH1-mutated Positive Hematologic Malignancies, Myelodysplastic Syndromes
- Trial name
- NCT02074839
- Testing
- AG-120
- Where
- 30 sites in United States, France
- Volunteers
- 291 people
- Sponsor
- Institut de Recherches Internationales Servier
Head and Neck Cancer Squamous Cell Carcinoma, Non-small Cell Lung Cancer
Study of ADCT-301 in Patients With Selected Advanced Solid Tumors
This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment…
- Conditions
- Head and Neck Cancer Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Gastric Cancer, Esophageal Cancer
- Trial name
- NCT03621982
- Testing
- ADCT-301, Pembrolizumab
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 78 people
- Sponsor
- ADC Therapeutics S.A.
Spinal Muscular Atrophy (SMA)
Clinical Trial to Assess the Safety and Efficacy of EXG001-307 in Patients With Spinal Muscular Atrophy
The purpose of this trial is to evaluate safety and efficacy of intrathecal delivery of EXG001-307 as a treatment of spinal muscular atrophy .
- Trial name
- NCT06888661
- Testing
- EXG001-307 injection
- Where
- 2 sites in China
- Volunteers
- 4 people
- Sponsor
- Guangzhou Jiayin Biotech Ltd
Acute Myeloid Leukemia/Myelodysplastic Syndrome, Multiple Myeloma (MM)
A Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Cancer Indications
THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase I study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 cells in seven refractory cancers…
- Trial name
- THINK (NCT03018405)
- Testing
- NKR-2 cells
- Where
- 5 sites in United States, Belgium
- Volunteers
- 146 people
- Sponsor
- Celyad Oncology SA
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
This is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA.
- Trial name
- NCT03334851
- Testing
- PF-06835375
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- Pfizer
Advanced Cancer
Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer
After the fourth protocol amendment two study arms are evaluated in this clinical protocol: PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and PF-05212384 plus irinotecan.
- Trial name
- NCT01347866
- Testing
- PF-05212384, PD-0325901, irinotecan
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 105 people
- Sponsor
- Pfizer
Chemotherapy-Induced Alopecia
Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia
The goal of this clinical trial is to learn if Compound 31543 (topical calcitriol) for treatment of hair-loss in patients with a diagnosis of breast cancer, gynecologic cancer or sarcomas receiving a taxane-based chemotherapy is…
- Trial name
- NCT01588522
- Testing
- Compound 31543 Calcitriol 5 μg/mL, Compound 31543 Calcitriol 10 μg/mL, Compound 31543 Calcitriol 20 μg/mL
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- BPGbio
Thrombosis, Cardiovascular Diseases
A Phase I SAD/MAD and Liver Effect Study of Vitalangio in Venous Thromboembolism Patients .
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug, Vitalangio1, in healthy male and female volunteers aged 18 to 55 years old.
- Trial name
- NCT07618351
- Testing
- Experimental: Food effect group, Active Comparator: Multiple dose group
- Where
- China
- Volunteers
- 627 people, healthy volunteers welcome
- Sponsor
- Peking University First Hospital
Non Hodgkin Lymphoma, Solid Tumor
SB-4826 in Adult Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphomas
The goal of this clinical trial is to learn what dose of the drug SB-4826 can be given safely in patients with solid tumors and non-Hodgkin lymphomas.
- Trial name
- NCT07222631
- Testing
- SB-4826, Rituximab
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of California, San Diego
Solid Tumor
Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Solid Tumors
This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA personalized neoantigen tumor vaccine in the treatment of advanced solid tumors, including two phases: dose escalation and…
- Trial name
- NCT05359354
- Testing
- Personalized neoantigen tumor vaccine
- Where
- China
- Volunteers
- 36 people
- Sponsor
- YueJuan Cheng
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