Clinical trials: Phase 1b
Acute-graft-versus-host Disease, aGVHD
A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).
- Conditions
- Acute-graft-versus-host Disease, aGVHD, GVHD, GVHD, Acute
- Trial name
- EQUATE (NCT03763318)
- Testing
- EQ001
- Where
- 16 sites in United States
- Volunteers
- 30 people
- Sponsor
- Biocon Limited
Lymphoma, Advanced Solid Tumors
Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101
This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intratumorally in participants with advanced solid tumors or lymphomas.
- Trial name
- NCT04144140
- Testing
- E7766
- Where
- 13 sites in United States, France and 3 more
- Volunteers
- 24 people
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
The purpose of this study is to determine the effect of TAK-925 after a single intravenous dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the maintenance of wakefulness (MWT) in sleep-deprived…
- Trial name
- NCT03522506
- Testing
- TAK-925, Modafinil
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Takeda
Neoplasms, Metastatic Cancer
Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042
Part A: To test the safety and tolerability of combination therapy with Niraparib and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
- Conditions
- Neoplasms, Metastatic Cancer, Advanced Cancer, Solid Tumor
- Trial name
- NCT03307785
- Testing
- Niraparib, TSR-042, Carboplatin-Paclitaxel
- Where
- 8 sites in United States
- Volunteers
- 60 people
- Sponsor
- Tesaro, Inc.
Relapsed/Refractory Aggressive B-cell Lymphomas
Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas
This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680 in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2 prior lines of therapy.
- Trial name
- NCT02271945
- Testing
- MEDI-551 12 mg/kg, MEDI0680 2.5 mg/kg, MEDI0680 10 mg/kg
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- MedImmune LLC
Vulvovaginal Candidiasis
Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis
This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess the safety, tolerability and humoral and cellular immune response over a 12-month period after receiving one dose of either the NDV-3A…
- Trial name
- NCT01926028
- Testing
- NDV-3A, NDV-3
- Where
- 20 sites in United States
- Volunteers
- 188 people
- Sponsor
- NovaDigm Therapeutics, Inc.
Metastatic Triple Negative Breast Cancer, Metastatic Colorectal Cancer
Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases
Approximately 36 DLT-evaluable subjects will be enrolled in this study. The locations of the study will be in the United States, Australia, Europe and Switzerland.
- Trial name
- NCT03256344
- Testing
- Talimogene Laherparepvec, Atezolizumab
- Where
- 17 sites in United States, Australia and 4 more
- Volunteers
- 36 people
- Sponsor
- Amgen
Solid Tumors
The Safety, Pharmacokinetics and Antitumor Activity of BGB-A317 in Combination With BGB-290 in Participants With Advanced Solid Tumors
This trial studied the safety, pharmacokinetics, and antitumor activity of the anti-programmed cell death 1 (PD-1) monoclonal antibody (mAb) BGB-A317 (tislelizumab) in combination with the poly(adenosine diphosphate ribose)…
- Trial name
- NCT02660034
- Testing
- Tislelizumab, Pamiparib
- Where
- 29 sites in United States, Australia and 4 more
- Volunteers
- 229 people
- Sponsor
- BeiGene
Hepatitis C, Chronic
A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants
The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12 (SVR12), in treatment-naive, chronic…
- Trial name
- COMMIT (NCT02268864)
- Testing
- Simeprevir, Daclatasvir
- Where
- 23 sites in Belgium, France and 4 more
- Volunteers
- 106 people
- Sponsor
- Janssen-Cilag International NV
Type 2 Diabetes Mellitus
Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes
Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes
- Trial name
- NCT01933672
- Testing
- PF-04937319 once-daily, PF-04937319 split-dose, Sitagliptin once-daily
- Where
- 8 sites in United States
- Volunteers
- 33 people
- Sponsor
- Pfizer
Gastric Adenocarcinoma
Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma
The purpose of this study was to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel and ramucirumab in patients with gastric adenocarcinoma (GAC) i.e.
- Trial name
- FIDES-03 (NCT04604132)
- Testing
- Derazantinib, Derazantinib-paclitaxel-ramucirumab combination
- Where
- 81 sites in United States, Argentina and 13 more
- Volunteers
- 47 people
- Sponsor
- Basilea Pharmaceutica
Multiple Myeloma
A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects
The primary objective was to determine the maximum tolerated dose of carfilzomib given twice weekly in combination with cyclophosphamide and dexamethasone for patients with newly diagnosed multiple myeloma.
- Trial name
- CHAMPION 2 (NCT01980589)
- Testing
- Carfilzomib, Cyclophosphamide, Dexamethasone
- Where
- 9 sites in United States
- Volunteers
- 22 people
- Sponsor
- Amgen
Metastatic Colorectal Carcinoma
A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI.
- Trial name
- NCT01937715
- Testing
- PF-05212384, FOLFIRI regimen, Bevacizumab
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 18 people
- Sponsor
- Pfizer
Locally Advanced or Metastatic Solid Tumor
A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in participants with advanced or metastatic…
- Trial name
- NCT03717415
- Testing
- Rebastinib, Carboplatin
- Where
- 9 sites in United States
- Volunteers
- 70 people
- Sponsor
- Deciphera Pharmaceuticals, LLC
Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer
Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers
SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum…
- Conditions
- Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Epithelial Ovarian Cancer, Ovarian Cancer
- Trial name
- NCT05483933
- Testing
- Pegylated Liposomal Doxorubicin + SL-172154, Mirvetuximab + SL-172154
- Where
- 21 sites in United States, Canada and 2 more
- Volunteers
- 86 people
- Sponsor
- Shattuck Labs, Inc.
Breast Cancer, Ovarian Cancer
FPA150 in Patients With Advanced Solid Tumors
This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of FPA150, an anti-B7H4 antibody alone or in combination with pembrolizumab an anti-PD1…
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer, Advanced Solid Tumors
- Trial name
- FPA150-001 (NCT03514121)
- Testing
- FPA150, Pembrolizumab
- Where
- 18 sites in United States, South Korea
- Volunteers
- 95 people
- Sponsor
- Five Prime Therapeutics, Inc.
Cystic Fibrosis
Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR function and inflammation in adult cystic…
- Trial name
- SNO-1 (NCT01746784)
- Testing
- N6022, Normal saline
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- Nivalis Therapeutics, Inc.
Allergic Rhinitis, Allergic Rhinitis Due to Grass Pollen
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis
This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of B244 delivered as an intranasal spray in…
- Conditions
- Allergic Rhinitis, Allergic Rhinitis Due to Grass Pollen, Healthy Volunteers
- Trial name
- NCT03290248
- Testing
- B244 suspension, Vehicle
- Where
- 2 sites in United States, Canada
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- AOBiome LLC
Non-Small Cell Lung Cancer, Melanoma
Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)
The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in participants with NSCLC.
- Conditions
- Non-Small Cell Lung Cancer, Melanoma, Mismatch Repair-Proficient Colorectal Cancer
- Trial name
- NCT02437136
- Testing
- entinostat, pembrolizumab
- Where
- 11 sites in United States
- Volunteers
- 191 people
- Sponsor
- Syndax Pharmaceuticals
Breast Cancer, Metastatic Breast Cancer
A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer
The primary objective of this study is to investigate the safety and tolerability of the anti-VEGFR-2 monoclonal antibody ramucirumab drug product in combination with docetaxel in Japanese participants with metastatic, or locally…
- Trial name
- NCT01256567
- Testing
- Ramucirumab, Docetaxel
- Where
- 4 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Eli Lilly and Company