Clinical trials: sponsored by Chipscreen Biosciences, Ltd.
Pancreatic Ductal Adenocarcinoma
Chiauranib in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.
- Trial name
- NCT06492915
- Testing
- Chiauranib, Albumin-paclitaxel Injection, Gemcitabine Injection
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Lymphoma, T-Cell, Peripheral
Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
A Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell…
- Trial name
- NCT06947967
- Testing
- CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone), Tucidinostat
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Chipscreen Biosciences, Ltd.
T2DM (Type 2 Diabetes Mellitus)
Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets
This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation…
- Trial name
- NCT07519265
- Testing
- Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1, Chiglitazar tablet, dose 1, Metformin extended-release tablet, dose 1
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Chipscreen Biosciences, Ltd.
T2DM (Type 2 Diabetes Mellitus)
Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets
This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test…
- Trial name
- NCT07412015
- Testing
- treatment T (dose 1), treatment T (dose 2), treatment R (dose 1)
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chipscreen Biosciences, Ltd.
Pancreatic Adenocarcinoma, Non Small Cell Lung Cancer
A Phase Ⅰ Study of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma
This is a phase I, open-label, first-in-human study of CS08399, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion.
- Conditions
- Pancreatic Adenocarcinoma, Non Small Cell Lung Cancer, Advanced Solid Tumors, Lymphoma
- Trial name
- NCT07583771
- Testing
- CS08399
- Where
- China
- Volunteers
- 186 people
- Sponsor
- Chipscreen Biosciences, Ltd.
T2DM (Type 2 Diabetes Mellitus)
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
The goal of this observational study is to evaluate the comprehensive clinical efficacy, cardiovascular, renal, and hepatic benefits, as well as the safety of adding Chiglitazar to SGLT-2 inhibitor therapy in adult patients with…
- Trial name
- NCT07580638
- Testing
- SGLT-2 inhibitor and Chiglitazar, SGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs)
- Volunteers
- 3,550 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Non Small Cell Lung Cancer
A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLC
A Randomized, Double-blind, Controlled, Multi-center Phase 2 Clinical study to Investigate the Efficacy and Safety of Tucidinostat (Chidamide) Combined with Tislelizumab as First-line Treatment for PD-L1 Positive Locally Advanced…
- Trial name
- NCT05519865
- Testing
- Tucidinostat, Tislelizumab
- Where
- China
- Volunteers
- 118 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Diffuse Large B-cell Lymphoma
Phase III Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed Double-Expressor DLBCL
Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. This Randomized, Double-blind, Placebo-controlled Phase 3 trail is studying the efficacy and safety of Tucidinostat, in…
- Trial name
- DEB (NCT04231448)
- Testing
- R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone), Tucidinostat
- Where
- 2 sites in China
- Volunteers
- 423 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Advanced Tumors
A Study of CS23546 in Subjects With Advanced Tumors
The primary objectives of this study are to characterize the safety and tolerability of CS23546 and to evaluate the pharmacokinetic (PK) characteristics and recommended phase 2 dose (RP2D) of CS23546 in subjects with advanced…
- Trial name
- NCT06245122
- Testing
- CS23546
- Where
- China
- Volunteers
- 156 people
- Sponsor
- Chipscreen Biosciences, Ltd.
T2DM (Type 2 Diabetes Mellitus)
Food Effect and Multiple-Dose Study of Chiglitazar/Metformin Extended-Release Tablets
This trial includes two parts: a food effect (FE) study and a multiple-dose pharmacokinetic (PK) study. The FE study is a randomized, open-label, two-period, two-sequence crossover study designed to evaluate the effect of a…
- Trial name
- NCT07511010
- Testing
- Chiglitazar/Metformin extended-release tablets under fasting conditions, Chiglitazar/Metformin extended-release tablets after a high-fat meal, multiple-dose of Chiglitazar/Metformin extended-release tablets
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Chipscreen Biosciences, Ltd.
Colorectal Cancer
A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients
A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients.
- Trial name
- NCT06497985
- Testing
- Tucidinostat, Sintilimab, Bevacizumab
- Where
- China
- Volunteers
- 430 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Metastatic Pancreatic Ductal Adenocarcinoma
Chiauranib Plus PD-1 Inhibitor, Albumin-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
This is a phase III, multi-center study to evaluate the efficacy and safety of chiauranib plus plus toripalimab, albumin-paclitaxel and gemcitabine as first-line therapy in patients with metastatic pancreatic ductal…
- Trial name
- NCT07445295
- Testing
- Chiauranib, Toripalimab Injection, Albumin-paclitaxel Injection
- Where
- China
- Volunteers
- 558 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Plaque Psoriasis
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
" This study consists of two parts: Part 1 (Dose Escalation): A randomized, double-blind, placebo-controlled phase in which approximately 20 to 30 adult patients with plaque psoriasis will receive the investigational treatment…
- Trial name
- MECAP (NCT07129382)
- Testing
- CS32582 capsule（low dose）, CS32582 capsule（medium dose）, CS32582 capsule（high dose）
- Where
- 11 sites in China
- Volunteers
- 220 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Neoplasms, Glioblastoma, Adult
Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors
This trial is a single-arm, open-label, first-in-human study of CS231295, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion.
- Conditions
- Neoplasms, Glioblastoma, Adult, Small Cell Lung Carcinoma (SCLC)
- Trial name
- NCT06902350
- Testing
- CS231295
- Where
- 2 sites in China
- Volunteers
- 102 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Soft Tissue Sarcoma
Chiauranib for Advanced or Unresectable Soft Tissue Sarcoma(STS)
This is a Phase 2, single-arm, open-label study in patients with advanced or unresectable soft tissue sarcoma.
- Trial name
- NCT05497843
- Testing
- Chiauranib
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Triple-negative Breast Cancer
A Phase II Study of Chiauranib in Combine With Capecitabine in TNBC
This study is to evaluate the preliminary efficacy and safety of chiauranib in combine with capecitabine in advanced triple-negative breast cancer failed to prior anthracyclines and taxanes therapy
- Trial name
- NCT05336721
- Testing
- Chiauranib, capecitabine
- Where
- 4 sites in China
- Volunteers
- 9 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Small Cell Lung Cancer
Phase 3 Clinical Study of Chiauranib Capsule in Patients With Small-cell Lung Cancer
Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.
- Trial name
- NCT04830813
- Testing
- Chiauranib
- Where
- China
- Volunteers
- 184 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Healthy
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Profiles and Food Effect of CS32582 Capsules
The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS32582 after single or multiple oral administration, as well as the food effect on the pharmacokinetics in healthy subjects.
- Trial name
- NCT06224595
- Testing
- CS32582 capsule
- Where
- China
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Chipscreen Biosciences, Ltd.
Ovarian Cancer, Relapsed or Refractory
Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer
This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent…
- Conditions
- Ovarian Cancer, Relapsed or Refractory, Chiauranib, Paclitaxel
- Trial name
- CHIPRO (NCT04921527)
- Testing
- chiauranib, Paclitaxel
- Where
- China
- Volunteers
- 454 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Non Small Cell Lung Cancer
Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced NSCLC.
This study is to evaluate the preliminary efficacy and safety of Chidamide combined with Envafolimab in patients with PD-1 inhibitor resistant advanced NSCLC.
- Trial name
- NCT05068427
- Testing
- Chidamide, Envafolimab
- Where
- 12 sites in China
- Volunteers
- 34 people
- Sponsor
- Chipscreen Biosciences, Ltd.