Clinical trials: Dose Escalation and Safety
Part 1, MELANOMA
A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors
Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in previously treated adult patients with…
- Conditions
- Part 1, MELANOMA, SCCHN, OVCA
- Trial name
- NCT02573259
- Testing
- PF-06801591
- Where
- 67 sites in United States, Bulgaria and 5 more
- Volunteers
- 147 people
- Sponsor
- Pfizer
Healthy
A Phase I Trial to Investigate the Safety and Tolerability of PF-06412562
This study will determine the safety and tolerability of PF-06412562 given orally to healthy volunteers. To determine the optimal dose for future studies, the concentration of the drug over time will be determined by periodic…
- Trial name
- NCT01914796
- Testing
- PF-06412562
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Plaque-type Psoriasis
Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis
A randomized, double-blind, placebo and positive controlled, single and multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in chronic plaque-type psoriasis patients.
- Trial name
- NCT01828086
- Testing
- CJM112, Secukinumab
- Where
- 18 sites in United States
- Volunteers
- 95 people
- Sponsor
- Novartis Pharmaceuticals
Relapsed Advanced Lymphomas
Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma
A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 in Patients with Relapsed Advanced Lymphoma (ADITI-1)
- Trial name
- ADITI-1 (NCT06755450)
- Testing
- AUR112
- Where
- 19 sites in India
- Volunteers
- 40 people
- Sponsor
- Aurigene Discovery Technologies Limited
Endometrial Cancer, Esophageal Cancer
ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen.
- Conditions
- Endometrial Cancer, Esophageal Cancer, Esophagogastric Junction (EGJ), Gastric (Stomach) Cancer
- Trial name
- NCT04044859
- Testing
- Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks
- Where
- 17 sites in United States, Canada and 1 more
- Volunteers
- 120 people
- Sponsor
- USWM CT, LLC
Healthy
A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557
To evaluate the safety and tolerability of a single IV dose of MEDI-557.
- Trial name
- NCT00578682
- Testing
- MEDI-557
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
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
Breast Cancer, Colon Cancer
Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients
This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor.
- Conditions
- Breast Cancer, Colon Cancer, Ovarian Cancer, Endometrium Cancer
- Trial name
- NCT01068483
- Testing
- BKM120
- Where
- 5 sites in United States, Canada and 2 more
- Volunteers
- 107 people
- Sponsor
- Novartis Pharmaceuticals
Hepatic Ascites
Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects
This trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary effectiveness of recombinant…
- Trial name
- NCT05249374
- Testing
- Recombinant Human Serum Albumin, Human serum albumin
- Where
- 8 sites in China
- Volunteers
- 36 people
- Sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.
Pulmonary Tuberculosis
Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.
- Trial name
- NCT01599897
- Testing
- ID93 + GLA-SE, ID93 alone
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Diabetes Mellitus, Diabetic Retinopathy
A Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)
This study is conducted to evaluate the safety of a single intravitreal injection of THR-687.
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
- Trial name
- NCT03666923
- Testing
- THR-687 dose level 1, THR-687 dose level 2, THR-687 dose level 3
- Where
- 7 sites in United States
- Volunteers
- 12 people
- Sponsor
- ThromboGenics
Respiratory Syncytial Virus (RSV)
A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults
The purpose of this study is to evaluate the safety and immunogenicity of two doses of the investigational RSV F subunit vaccine administered intramuscularly (IM).
- Trial name
- NCT02298179
- Testing
- RSV F subunit 45 μg No adjuvant, RSV F subunit 45 μg Aluminum hydroxide adjuvant, RSV F subunit 45 μg MF59 adjuvant
- Where
- Belgium
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lung Cancer
A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive Mutation
This phase I trial with dose-escalation stage and dose-expansion stage is the first-in-human study of FCN-411, a drug being developed for treatment of advanced cancers.
- Trial name
- NCT03420079
- Testing
- FCN-411 Dose-escalation, FCN-411 Dose-expansion
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Ahon Pharmaceutical Co., Ltd.
Neoplasms, Carcinoma, Hepatocellular
A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
This is the first in human trial clinical study of AST-201 in patients with GPC3-positive advanced solid tumors. This study aims to evaluate the safety, tolerability, pharmacokinetic properties, and preliminary efficacy of…
- Conditions
- Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Liver Neoplasms
- Trial name
- NCT06687941
- Testing
- AST-201
- Where
- 4 sites in South Korea
- Volunteers
- 70 people
- Sponsor
- Aptamer Sciences, Inc.
Healthy Volunteers
A Study of LY3079514 in Healthy Participants
The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of study drug, LY3079514. This study will last about 12 weeks for each participant.
- Trial name
- NCT02242903
- Testing
- LY3079514
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Melanoma
RBL001/RBL002 Phase I Clinical Trial
Clinical first-in-human dose escalation study evaluating the safety and tolerability of intranodal administration of an RNA-based cancer vaccine targeting two tumor-associated antigens in patients with advanced melanoma
- Trial name
- MERIT (NCT01684241)
- Testing
- RBL001/RBL002
- Where
- 4 sites in Austria, Germany
- Volunteers
- 29 people
- Sponsor
- BioNTech RNA Pharmaceuticals GmbH
Solid Tumor
Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors
This is a multicenter, open-label, dose-escalation study to assess the safety, tolerability and Pharmacokinetics of MGFR1877S.
- Trial name
- NCT01363024
- Testing
- MFGR1877S
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Genentech, Inc.
Epilepsy, Partial
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.
- Trial name
- NCT00152451
- Testing
- Seletracetam (ucb 44212)
- Where
- 7 sites in United States
- Volunteers
- 31 people
- Sponsor
- UCB S.A. - Pharma Sector
Locally Advanced Solid Tumor
Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors
The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of…
- Trial name
- NCT04084366
- Testing
- OBI-999
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- OBI Pharma, Inc
Safety, Tolerability
TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms
This is a multicentre, non-randomized, open-label, Phase I/II clinical trial of MDG1011, an investigational medicinal product (IMP), consisting of patient-derived autologous T cells, persistently transduced with a Preferentially…
- Conditions
- Safety, Tolerability, Feasibility, Treatment Efficacy
- Trial name
- NCT03503968
- Testing
- MDG1011, Investigator Choice therapy
- Where
- 9 sites in Germany
- Volunteers
- 9 people
- Sponsor
- Medigene AG
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