Clinical trials: Clinical Trial, Phase I
Advanced Malignant Tumors
JSKN033 in Chinese Subjects with Advanced Malignant Tumors
This is a phase I/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors.
- Trial name
- NCT06770881
- Testing
- JSKN033
- Volunteers
- 430 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Neutropenia
Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product)…
- Trial name
- NCT04873765
- Testing
- Pegfilgastrim Megalabs, Pegfilgastim Amgen
- Where
- Uruguay
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Megalabs
Specific Advanced Solid Tumors
Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors
Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to determine the maximum tolerated dose (MTD)…
- Trial name
- NCT01970553
- Testing
- lurbinectedin (PM01183), Gemcitabine
- Where
- 3 sites in Spain, United Kingdom
- Volunteers
- 47 people
- Sponsor
- PharmaMar
Major Depressive Disorder
To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Subjects
This is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the…
- Trial name
- NCT07371065
- Testing
- LY03021
- Where
- China
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Metastatic Pancreatic Cancer
Phase I Trial of LCL161 and Gemcitabine Plus Nab-Paclitaxel in Metastatic Pancreatic Cancer
The goal of this study is to identify the maximum tolerated dose and dose-limiting side effects of LCL161 in combination with gemcitabine and nab-paclitaxel and to provide safety data in patients with measurable metastatic…
- Trial name
- NCT01934634
- Testing
- LCL161, Gemcitabine, nab-Paclitaxel
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- US Oncology Research
Safety and Tolerability
Phase 1 Clinical Study of JMKX003142 Tablets
Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of JMKX003142 tablets administered randomly, double-blind, placebo-controlled single and multiple times in healthy adult subjects…
- Trial name
- NCT06079541
- Testing
- JMKX003142 will be administered orally
- Where
- China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Jemincare
Leukemia, Myeloid, Acute
Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia
The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, BI 6727 will be investigated as monotherapy and in combination with low dose cytarabine (LD-Ara-C) in patients with…
- Trial name
- NCT00804856
- Testing
- Volasertib, Cytarabine
- Where
- 27 sites in Austria, Belgium and 5 more
- Volunteers
- 180 people
- Sponsor
- Boehringer Ingelheim
Breast Cancer
A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer
This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer.
- Trial name
- NCT05080842
- Testing
- AC682
- Where
- 5 sites in United States
- Volunteers
- 21 people
- Sponsor
- Accutar Biotechnology Inc
Schizophrenia
A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of KR23248 Capsules in Healthy Adult Subjects
This study aims to investigate the safety, tolerability and pharmacokinetic characteristics of KR23248 capsules in healthy subjects. This study will be conducted in China.
- Trial name
- NCT07585383
- Testing
- KR23248
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
Neoplasms
Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.
- Trial name
- NCT00969553
- Testing
- BI 6727
- Where
- 2 sites in Taiwan
- Volunteers
- 59 people
- Sponsor
- Boehringer Ingelheim
Healthy
Relative Bioavailability (rBA) of Evobrutinib Intended Commercial and Clinical Tablets, and Effect of Food on Intended Commercial Tablets
The study will evaluate the relative bioavailability (rBA) of the intended commercial tablet formulation (Test Treatment, TF2) of Evobrutinib compared to the clinical tablet formulation (Reference Treatment, TF1) of Evobrutinib…
- Trial name
- NCT04314024
- Testing
- Evobrutinib
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Influenza
A Phase 1/2 Clinical Trial of an Alphavirus Replicon Vaccine for Influenza
AVX502, an alphavirus replicon vaccine expressing an influenza HA protein, is a candidate vaccine against influenza. The objectives of this Phase 1 study are to test the safety of the vaccine and the immune response to the…
- Trial name
- NCT00440362
- Testing
- AVX502
- Where
- United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- AlphaVax, Inc.
Randomised Clinical Trial, Double Blind
Phase I Study of VLPDEN-02 Dengue Vaccine in Healthy Adults
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study. Forty-two flavivirus-naïve adults will be enrolled and will receive 3 administrations of VLPDEN-02 or control at days 0, 28, and 56.
- Conditions
- Randomised Clinical Trial, Double Blind, Dengue, Challenge Test
- Trial name
- NCT07831473
- Testing
- VLPDEN-02 1.0 µg (0.25 µg of each VLP) + ALFQ adjuvant, VLPDEN-02 10 µg (2.5 µg of each VLP) + ALFQ adjuvant, VLPDEN-02 100 µg (25 µg of each VLP) + ALFQ adjuvant
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- VLP Therapeutics
Glioma, Brain Neoplasm
Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.
This drug is being developed to treat a type of brain cancer, glioma. This study was designed to determine a safe and well tolerated dose.
- Trial name
- NCT00040573
- Testing
- 131I-TM-601
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- TransMolecular
Breast Cancer
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
In the phase I part, to determine the recommended doses (RD) and dosing regimens of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive…
- Trial name
- NeoB-Cap1 (NCT06247995)
- Testing
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Capecitabine
- Where
- 28 sites in United States, Australia and 11 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Malignant Solid Tumors
A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RCZY690 in Advanced Solid Tumors
This study aims to evaluate the safety and efficacy of RCZY690 therapy in participants with advanced malignant solid tumors. Participants will receive RCZY690 monotherapy until the end of the study.
- Trial name
- NCT07806175
- Testing
- RCZY690 Tablets, RCZY690 tables
- Where
- 8 sites in China
- Volunteers
- 486 people
- Sponsor
- Rongchang Pharmaceuticals Co., Ltd.
Advanced Solid Tumors or Lymphomas
A Study of CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and Lymphomas
CA-170 is a rationally designed and orally available, small molecule that directly targets the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints and results…
- Trial name
- NCT02812875
- Testing
- CA-170
- Where
- 20 sites in United States, South Korea and 2 more
- Volunteers
- 71 people
- Sponsor
- Curis, Inc.
Neoplasms
Dose Escalation Trial of BIBW 2992 Administration in Combination With Docetaxel in Patients With Advanced Solid Tumors
Study to determine the maximum tolerated dose (MTD) for various treatment durations of BIBW 2992 when administered in combination with docetaxel as determined by drug-related adverse events (AEs) as well as Pharmacokinetics…
- Trial name
- NCT02171741
- Testing
- BIBW 2992, Docetaxel
- Volunteers
- 31 people
- Sponsor
- Boehringer Ingelheim
Total Thyroidectomy, Near-total Thyroidectomy
Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients
This study is designed as a combination of phase 1 (Part A) and phase 2 (Part B). The purpose of Part A was to determine the safety, tolerability, and pharmacokinetics in patients with total thyroidectomy or near total…
- Trial name
- NCT03276988
- Testing
- Period 1 GX-30, Period 2 THYROGEN®, Period 1 THYROGEN®, Period 2 GX-30
- Where
- 5 sites in South Korea
- Volunteers
- 8 people
- Sponsor
- Genexine, Inc.
Type 1 Diabetes Mellitus
Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
This clinical study will evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas.
- Trial name
- NCT03272269
- Testing
- IMCY-0098
- Where
- 17 sites in Belgium, Denmark and 5 more
- Volunteers
- 41 people
- Sponsor
- Imcyse SA
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