Clinical trials: Dose Escalation and Safety
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Study of ADCT-301 in Patients With Relapsed/Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia (ALL)
This study evaluates ADCT-301 in participants with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL). Participants will participate in a dose-escalation phase (Part 1) and receive ADCT-301 either weekly or once…
- Trial name
- NCT02588092
- Testing
- ADCT-301
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- ADC Therapeutics S.A.
Healthy
Phase I Safety Study of Inhaled N-IP-00001 to Determine Tolerability and Safety in Healthy Volunteers.
Randomized, double-blind, placebo-controlled, dose-escalation Phase I safety study of inhaled N-IP-00001, to determine tolerability and safety in healthy volunteers.
- Trial name
- NCT06662019
- Testing
- N-IP-00001 inhalation solution, 0.9% NaCl isotonic saline solution
- Where
- 2 sites in Australia
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- NeoTrials Pty Ltd
Healthy
A Study to Test How Different Doses of BI 456906 Are Tolerated in Japanese Men With a Body Mass Index (BMI) Between 23 and 40 kg/m2
Main objectives are to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of different dose escalation schemes of BI 456906 in healthy Japanese male subject with BMI 23-40 kg/m2 and to determine a dose…
- Trial name
- NCT04384081
- Testing
- BI 456906
- Where
- Japan
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Retinal Disease, Macular Degeneration
Safety & Efficacy of Eyecyte-RPE™ in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration.
The goal of this clinical study is to evaluate the safety and efficacy of novel stem cell formulation in patients having Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (d-AMD).
- Conditions
- Retinal Disease, Macular Degeneration, Age-Related Macular Degeneration, Geographic Atrophy
- Trial name
- NCT06394232
- Testing
- Eyecyte-RPE™
- Where
- 3 sites in India
- Volunteers
- 54 people
- Sponsor
- Eyestem Research Pvt. Ltd.
Lung Cancer (Locally Advanced or Metastatic)
Pemefolacianine for IMI of Lung Cancer
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of Pemefolacianine for Injection, a novel fluorescence imaging agent developed by Nanjing Nuoyuan Medical Devices Co., Ltd…
- Trial name
- NCT07772895
- Testing
- Pemefolacianine Cohort 1 in Part A, Pemefolacianin Cohort 2 in Part B
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Sunil Singhal
Advanced Solid Tumor, Metastatic Solid Tumor
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Soft Tissue Sarcoma (STS), Platinum-resistant Ovarian Cancer (PROC)
- Trial name
- NCT05824975
- Testing
- GI-102 subcutaneous (SC), GI-102, doxorubicin
- Where
- 11 sites in United States, South Korea
- Volunteers
- 358 people
- Sponsor
- GI Innovation, Inc.
HER-2 Positive Advanced Solid Tumors
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary…
- Trial name
- NCT05957536
- Testing
- D3L-001
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 128 people
- Sponsor
- D3 Bio (Wuxi) Co., Ltd
Ppancreatic Cancer
Study on Efficacy and Safety of VMAT Technique With Local Dose Escalation for Unresectable Pancreatic Cancer
The goal of this observational study is to learn about the efficacy and safety of the Volumetric Modulated Arc Therapy (VMAT) dose sculpting technique combined with different radiotherapy doses (local dose escalation vs.
- Trial name
- NCT07242911
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Chifeng Tumor Hospital
Advanced Hepatocellular Carcinoma
Phase I Clinical Trial of CT0181 Cells in the Treatment of Hepatocellular Carcinoma
A Phase I Clinical Study of CT0181 cells in Patients with Advanced Hepatocellular Carcinoma
- Trial name
- NCT04973098
- Testing
- CT0181 Cells
- Where
- China
- Volunteers
- 13 people
- Sponsor
- Peking University
Asthma
A Study to Evaluate the Safety and Tolerability of the Administration of MEDI-528 When Administered in Multiple Doses to Adults With Mild Persistent Asthma
The primary objective of this study is to evaluate the safety and tolerability of escalating multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.
- Trial name
- NCT00507130
- Testing
- MEDI528 0.3 mg/kg, MEDI528 1 mg/kg, MEDI528 3 mg/kg
- Where
- 9 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- MedImmune LLC
Advanced Melanoma
Safety and Efficacy of DCB-BO1301 in Advanced Melanoma
The primary study objectives are 1. to evaluate the safety and tolerability profiles of DCB-BO1301 and to determine the maximum tolerated dose (MTD) of DCB-BO1301 as add-on therapy to dacarbazine in subjects with advanced…
- Trial name
- NCT02994498
- Testing
- DCB-BO1301
- Volunteers
- 33 people
- Sponsor
- Chung Mei Biopharma Co., Ltd
Influenza A, Pandemic Influenza
H7HLAII DNA Influenza Vaccine
The purpose of this study is to assess safety and immunogenicity of H7HLAII, a DNA vaccine encoding influenza hemagglutinin (HA) from influenza A/Shanghai/2/2013 (H7N9) directed to cells expressing human leukocyte antigen class…
- Trial name
- H7N9vax-1 (NCT06046092)
- Testing
- H7HLAII
- Where
- Norway
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Oslo University Hospital
Overweight and/or Obesity, Weight Management
A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity
- Trial name
- NCT07243171
- Testing
- ecnoglutide tablets
- Where
- China
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
Healthy Subjects
A Clinical Study of AK139 in Healthy Subjects
This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.
- Trial name
- NCT06947109
- Testing
- AK111
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Akeso
Heterozygous Familial Hypercholesterolemia (HeFH)
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
A phase 1/2, two-part trial consisting of an open label dose-escalation part and a randomized, double blind, placebo-controlled part to investigate safety, tolerability, pharmacokinetics, and efficacy with EDIT-401 gene editing…
- Trial name
- NCT07894887
- Testing
- Drug: EDIT-401
- Where
- 2 sites in Australia
- Volunteers
- 56 people
- Sponsor
- Editas Medicine, Inc.
Pachyonychia Congenita
Study of TD101, a Small Interfering RNA (siRNA) Designed for Treatment of Pachyonychia Congenita
Pachyonychia congenita (PC) is a rare, autosomal dominant keratin disorder affecting the nails, skin, oral mucosae, larynx, hair and teeth.
- Trial name
- NCT00716014
- Testing
- TD101
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pachyonychia Congenita Project
Breast Cancer
Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer
The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of cancerous tumors that are HER-2 positive.
- Trial name
- NCT01325207
- Testing
- Trastuzumab
- Where
- 8 sites in United States
- Volunteers
- 34 people
- Sponsor
- Northwestern University
Psoriasis Vulgaris
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
This Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of HRS-4139 in healthy participants.
- Trial name
- NCT07802964
- Testing
- HRS-4139 Tablet
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Mantle Cell Lymphoma Refractory
Escalating Doses of Torisel in Combination With Three Chemotherapies Regimens: R-CHOP, R-FC or R-DHA for Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL).
This is a multicenter, open label, three arms, Phase IB study. A dose escalation phase of Temsirolimus (Torisel™) administered in intravenous (IV) at day 2, day 8 and day 15 in combination with three chemotherapies regimens for…
- Trial name
- T³ (NCT01389427)
- Testing
- Torisel dose 15 mg and R-CHOP, Torisel dose 15 mg and R-FC, Torisel dose 15 mg and R-DHA
- Where
- 11 sites in France
- Volunteers
- 41 people
- Sponsor
- The Lymphoma Academic Research Organisation
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
PH009-1 in Patients With EGFR Mutation Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
The study will contain three stages: Phase I includes dose escalation phase (i.e., phase Ia) and dose expansion phase (i.e., phase Ib).
- Trial name
- NCT06590194
- Testing
- PH009-1 tablet
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Suzhou Puhe Pharmaceutical Technology Co., LTD
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