Clinical trials: sponsored by Evopoint Biosciences Inc.
Metastatic Castrate-Resistant Prostate Cancer, mCRPC (Metastatic Castration-resistant Prostate Cancer)
Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer
In this phase Ib/II study, participants with metastatic castration-resistant prostate cancer (mCRPC) who failed prior novel hormone therapy will be treated with XNW5004 in combination with enzalutamide.
- Trial name
- NCT06702995
- Testing
- XNW5004, enzalutamide
- Where
- 2 sites in China
- Volunteers
- 307 people
- Sponsor
- Evopoint Biosciences Inc.
Advanced Tumor, Lymphoma
To Evaluate a Phase I/II Clinical Study of XNW5004 Tablets in Patients With Relapsed/Refractory Advanced Tumors
Patients with advanced tumors diagnosed histologically or cytologically at the study center who were refractory to standard therapy or had relapsed received XNW5004 tablets
- Trial name
- NCT06558513
- Testing
- XNW5004 tablets
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Evopoint Biosciences Inc.
Tumor, Solid
A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment
The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .
- Trial name
- NCT06987500
- Testing
- XNW29016
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Evopoint Biosciences Inc.
Pancreatic Cancer
Study of XNW28012 in Subjects With Metastatic Pancreatic Cancer Who Received Prior Systemic Therapy
This study was a randomized, double-blind, multicenter phase III clinical study. A total of 226 patients with metastatic pancreatic ductal carcinoma who had failed or were intolerant to two previous standard therapies were…
- Trial name
- NCT07823049
- Testing
- XNW28012 for injection, XNW28012 Mimetic for Injection
- Where
- 48 sites in China
- Volunteers
- 226 people
- Sponsor
- Evopoint Biosciences Inc.
Non-hodgkin Lymphoma, Peripheral T-cell Lymphoma
Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma
In this study, the XNW5004 tablets combined with CHOP/CHOEP will be used for the treatment of newly diagnosed PTCL patients.
- Trial name
- NCT07730515
- Testing
- XNW5004 combined with CHOP (incremental), XNW5004 combined with CHOEP (incremental), XNW5004 combined with CHOP (extended)
- Where
- China
- Volunteers
- 176 people
- Sponsor
- Evopoint Biosciences Inc.
Advanced Prostate Cancer
Study of XNW5004 Tablets in Advanced Prostate Cancer
Phase Ib A preliminary design of 2 cohorts is planned for this phase, with 3-6 participants to be enrolled in each cohort. A total of 6-12 participants with advanced prostate cancer are planned to be enrolled in this phase.
- Trial name
- XNW5004 Tablet (NCT07730580)
- Testing
- XNW5004 1200 mg BID in Combination with Abiraterone plus Prednisone, XNW5004 1200 mg BID in Combination with Docetaxel plus Prednisone, XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO BID
- Volunteers
- 242 people
- Sponsor
- Evopoint Biosciences Inc.
Carcinoma, Squamous Cell Carcinoma of Head and Neck
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
In this study, participants with different types of advanced solid tumors who failed standard treatments will be treated with XNW5004 in combination with KEYTRUDA® (pembrolizumab) .
- Conditions
- Carcinoma, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma, Prostate Cancer
- Trial name
- NCT06022757
- Testing
- XNW5004, KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Evopoint Biosciences Inc.
Metastatic Pancreatic Cancer
Phase I Open-Label Randomized Multicenter Study of XNW28012 Monotherapy in Metastatic Pancreatic Cancer
A Phase I, Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of XNW28012 Monotherapy in the Treatment of Subjects with Metastatic Pancreatic Cancer
- Trial name
- NCT07707674
- Testing
- XNW28012
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Evopoint Biosciences Inc.
Follicular Lymphoma, Grade 1, Follicular Lymphoma, Grade 2
Clinical Study of XNW5004 Tablets in the Treatment of Relapsed and Refractory Follicular Lymphoma
This is a single-arm, open-label, multicenter Phase II clinical study designed to enroll 65 subjects with relapsed or refractory follicular lymphoma (EZH2 wild-type).
- Conditions
- Follicular Lymphoma, Grade 1, Follicular Lymphoma, Grade 2, Follicular Lymphoma, Grade 3, Follicular Lymphoma Grade 3A
- Trial name
- NCT07545603
- Testing
- XNW5004 tablets
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Evopoint Biosciences Inc.
Advanced Solid Tumors, Pancreatic Carcinoma
Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments
This is an open-label, dose escalation, multicenter, phase 1, first-in-human study of XNW28012 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies or are intolerant to such therapies.
- Conditions
- Advanced Solid Tumors, Pancreatic Carcinoma, Ovarian Cancer, Cervical Cancers
- Trial name
- NCT06799637
- Testing
- XNW28012
- Where
- 24 sites in China
- Volunteers
- 350 people
- Sponsor
- Evopoint Biosciences Inc.
Relapsed/Refractory Peripheral T Cell Lymphoma
A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
This is a randomized, double-blind, multi-center, phase III clinical trial designed to evaluate the efficacy of XNW5004 tablets versus Chidamide in Relapsed/Refractory PTCL, with a target of enrolling 120 subjects.
- Trial name
- NCT06776952
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Evopoint Biosciences Inc.
Advanced Solid Tumors
A Phase I/II Study to Evaluate XNW34017 in Patients With Advanced or Metastatic Solid Tumor
This study is an open-label, dose-escalation, multicenter Phase I/II study conducted in patients with advanced solid tumors. The target population for this study consists of patients with advanced solid tumors who have failed or…
- Trial name
- NCT07327294
- Testing
- XNW34017
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Evopoint Biosciences Inc.
Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia (XNW4107-302, REITAB-2)
This study aims to compare treatment with Imipenem/Cilastatin-XNW4107 (IMI-XNW4107) with imipenem/cilastatin/relebactam (IMI/REL) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB…
- Trial name
- REITAB-2 (NCT05204563)
- Testing
- Combination of Imipenem/Cilastatin and XNW4107, Imipenem/Cilastatin/Relebactam
- Where
- 35 sites in United States, France and 2 more
- Volunteers
- 450 people
- Sponsor
- Evopoint Biosciences Inc.
Relapsed/Refractory Peripheral T Cell Lymphoma
To Evaluate XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma
This is an open-label, multi-center clinical study to evaluate the efficacy and safety of XNW5004 tablets in subjects with R/R PTCL. The study plans to enroll approximately 50 subjects.
- Trial name
- NCT06702605
- Testing
- XNW5004 tablets
- Volunteers
- 50 people
- Sponsor
- Evopoint Biosciences Inc.
Bacterial Infections
Pharmacokinetics of XNW4107 in Subjects With Various Degrees of Renal Function
This is a Phase 1, open-label study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-minute (60-min) IV infusion to adults with various degrees of renal insufficiency as compared to…
- Trial name
- NCT04787562
- Testing
- XNW4107, Imipenem/Cilastatin
- Where
- 2 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Evopoint Biosciences Inc.
Complicated Urinary Tract Infection Including Acute Pyelonephritis
Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40)
This is A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/Funobactam in Comparison with Meropenem in Hospitalized Adults with…
- Trial name
- NCT05204368
- Testing
- Combination of Imipenem/Cilastatin and XNW4107, Meropenem
- Where
- United States
- Volunteers
- 780 people
- Sponsor
- Evopoint Biosciences Inc.
Bacterial Infections
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin
This is a 3-part, first-in-human study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy male subjects.
- Trial name
- NCT04482569
- Testing
- XNW4107
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Evopoint Biosciences Inc.
Bacterial Infections
Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects
This is a Phase 1, open-label, single-center study of XNW4107 and imipenem/cilastatin administered intravenously.
- Trial name
- NCT04802863
- Testing
- XNW4107, Imipenem/Cilastatin
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Evopoint Biosciences Inc.
Bacterial Infections
To Evaluate the Pharmacokinetics of XNW4107 in Healthy Adult Young Females and in Healthy Adult Elderly Males and Females.
This is a Phase 1, randomized, double-blind, placebo-controlled study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-min (± 3 min) IV infusion in healthy adult young females and…
- Trial name
- NCT04801043
- Testing
- XNW4107, Imipenem/Cilastatin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Evopoint Biosciences Inc.
Advanced Solid Tumors
Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of XNW7201 in Subjects With Advanced Solid Tumors
The research project is testing this potential new medication for advanced solid tumours. This research project is being done to get more information about the study drug (XNW7201).
- Trial name
- NCT03901950
- Testing
- XNW7201 tablets
- Where
- Australia
- Volunteers
- 45 people
- Sponsor
- Evopoint Biosciences Inc.