Clinical trials: Phase I
Advanced Solid Tumor, Metastatic Triple-Negative Breast Cancer
Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
The primary objectives of this study are as follows: Phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent and to determine the recommended Phase 2 dose…
- Conditions
- Advanced Solid Tumor, Metastatic Triple-Negative Breast Cancer, HR+/HER2- Metastatic Breast Cancer, Metastatic Urothelial Cancer
- Trial name
- ASCENT-J02 (NCT05101096)
- Testing
- Sacituzumab Govitecan-hziy
- Where
- 36 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Gilead Sciences
Healthy
A Study to Evaluate Potential Drug Interactions Between ALXN2080 and Itraconazole, Fluconazole & Carbamazepine in Healthy Adults
The primary objectives of this study are to determine the effect of multiple doses of itraconazole on the single dose PK of ALXN2080, to determine the effect of multiple doses of fluconazole on the single dose PK of ALXN2080…
- Trial name
- NCT06173596
- Testing
- ALXN2080, Itraconazole, Fluconazole (AxMP)
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Neoplasms
Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly.
- Trial name
- NCT00998296
- Testing
- BIBW 2992, BIBF 1120
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Boehringer Ingelheim
Infection, Human Immunodeficiency Virus
Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers
This study will be a phase I, open label, two arm, fixed sequence crossover study to investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of GSK1349572 and the safety and tolerability of…
- Trial name
- NCT01231542
- Testing
- GSK1349572, Rifampin, Rifabutin
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD)
Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.
- Trial name
- NCT05058105
- Testing
- FL058 500mg and Meropenem 1000mg（ IV 120min）, FL058 1000mg（ IV 120min）, Meropenem 1000 mg （ IV 120min）
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Cancer, Advanced Cancer
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population.
- Conditions
- Cancer, Advanced Cancer, Locally Advanced Carcinoma, Metastatic Solid Tumor
- Trial name
- NCT06440005
- Testing
- AGX101
- Where
- 7 sites in United States
- Volunteers
- 80 people
- Sponsor
- Angiex, Inc.
Healthy
A Study of HM11260C in Healthy Male Subject
Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design. Five ascending dose cohorts are planned.
- Trial name
- NCT01093729
- Testing
- HM11260C
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Advanced Cancer, Advanced Solid Tumors
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as…
- Trial name
- NCT06656390
- Testing
- ALK201
- Where
- 38 sites in United States, Australia and 1 more
- Volunteers
- 202 people
- Sponsor
- Shanghai Allink Biotherapeutics Co., Ltd.
Systemic Lupus Erythematosus, Lupus Nephritis
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
- Trial name
- NCT06121297
- Testing
- CABA-201
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 28 people
- Sponsor
- Cabaletta Bio
Carcinoma, Non-small-cell Lung
A Study Evaluating Dalotuzumab (MK-0646) in Combination With Erlotinib for Participants With Non-Small Cell Lung Cancer (MK-0646-007)
This is a Phase I/IIa study to evaluate safety and efficacy of dalotuzumab (MK-0646) in combination with erlotinib in participants with recurrent Non-Small Cell Lung Cancer (NSCLC).
- Trial name
- NCT00654420
- Testing
- Dalotuzumab, Erlotinib
- Volunteers
- 95 people
- Sponsor
- Merck Sharp & Dohme LLC
MTAP Deletion
A Study of HS-10587 in Patients With Advanced Solid Tumors
This is a Phase I, multicenter, open-label clinical trial with dose escalation/dose expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy…
- Trial name
- NCT07567859
- Testing
- HS-10587
- Volunteers
- 362 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Colorectal Cancer, Breast Cancer
Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors
SNB-101 is a novel nano-particle formulation of SN-38, the active metabolite of irinotecan(CPT-11). Study SNB101P01 is a multicenter, open-label, dose escalation, phase 1 study of SNB 101 with its active ingredient SN-38, in…
- Conditions
- Colorectal Cancer, Breast Cancer, Pancreas Cancer, Ovarian Cancer
- Trial name
- NCT04640480
- Testing
- SNB-101
- Where
- 3 sites in South Korea
- Volunteers
- 21 people
- Sponsor
- SN BioScience
Healthy
A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects
This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted normal healthy males.
- Trial name
- NCT01798979
- Testing
- GLPG0634, Midazolam
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Healthy
A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants
The main purpose of this study is to evaluate how much of the study drug (LY3473329), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air…
- Trial name
- NCT06342596
- Testing
- [14C]-LY3473329, LY3473329
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Influenza
Safety, Tolerability, and PK of Escalating Doses of Flufirvitide-3 Dry Powder for Inhalation in Healthy Subjects
To evaluate the safety, tolerability and pharmacokinetics (PK) of single,and repeat escalating doses of FF-3 dry powder administered via inhalation in healthy adult subjects
- Trial name
- NCT01990846
- Testing
- Flufirvitide 3
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Autoimmune Technologies, LLC
Healthy
A Phase 1 Study of ANJ900 Chinese Healthy Subjects
This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and female Chinese subjects. Subjects will participate in 3 treatment periods and will be randomised in a 1:1:1 ratio to 1 of 3 treatment…
- Trial name
- NCT05151146
- Testing
- ANJ900, Metformin IR
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Anji Pharma
Schizophrenia
Positron Emission Tomagraphy (PET) Study Following a Single Oral Dose of OPC-34712
Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht dose levels in healthy volunteers.
- Trial name
- NCT00805454
- Testing
- OPC-34712
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
ACCEL is a multicenter, open label phase Ia/Ib/II study of [Ac-225]-PSMA-62 in participants with prostate-specific membrane antigen (PSMA)-positive prostate cancer.
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Oligometastatic Prostate Carcinoma, Hormone Sensitive Prostate Cancer
- Trial name
- ACCEL (NCT06229366)
- Testing
- [Ac-225]-PSMA-62 (mCRPC), [Ac-225]-PSMA-62 (OmHSPC)
- Where
- 7 sites in Canada
- Volunteers
- 142 people
- Sponsor
- Eli Lilly and Company
Stage IV Pancreatic Cancer
VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer
First-in-human phase I dose escalation study in patients with locally advanced, inoperable and stage IV pancreatic cancer to examine safety, tolerability, and immune response to the investigational VEGFR-2 DNA vaccine VXM01 to…
- Trial name
- NCT01486329
- Testing
- VXM01
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Vaximm GmbH
Impaired Hepatic Function
Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function
This is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function
- Trial name
- NCT04823702
- Testing
- Aldafermin
- Where
- 3 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- NGM Biopharmaceuticals, Inc
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