Clinical trials: Envafolimab
Advanced Solid Tumor
Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program
Envafolimab is a novel PD-L1 inhibitor administered via subcutaneous (SC) injection - notably the first such checkpoint inhibitor approved for use worldwide.[1] In November 2021, Envafolimab received its first approval in China…
- Trial name
- ENCOMPASS STUD (NCT07562347)
- Testing
- Envafolimab
- Volunteers
- 120 people
- Sponsor
- IR INNOVATE RESEARCH PRIVATE LIMITED
Advanced Sarcoma, Metastatic Sarcoma
YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma
This is a multicenter, open label, Phase 1/2 study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma…
- Conditions
- Advanced Sarcoma, Metastatic Sarcoma, Soft Tissue Sarcoma
- Trial name
- NCT05448820
- Testing
- YH001, Envafolimab, Doxorubicin
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Tracon Pharmaceuticals Inc.
Healthy Male
Phase I Trial of Envafolimab for Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change.
- Trial name
- NCT05849311
- Testing
- Envafolimab with new manufacturing process, Envafolimab with old manufacturing process
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
Solid Tumors, Non-small Cell Lung Cancer
Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors
This is an open-label, multi-center study of Phase Ib/II study to assess the efficacy and safety of Envafolimab combinded with Lenvatinib in the treatment of subjects with advanced solid tumors.
- Conditions
- Solid Tumors, Non-small Cell Lung Cancer, Renal Cell Carcinoma, Hepatocellular Carcinoma
- Trial name
- NCT05024214
- Testing
- Lenvatinib + Envafolimab, Sunitinib
- Where
- 23 sites in China
- Volunteers
- 170 people
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
Advanced Endometrial Cancer
Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer
This is an open-label, multi-center, multi-corhort Phase II study of Envafolimab alone or with Lenvatinib in patients with advanced endometrial cancer.The primary objective is to evaluate objective response rate of envafolimab…
- Trial name
- NCT05112991
- Testing
- Envafolimab+Lenvatinib, Envafolimab
- Where
- 19 sites in China
- Volunteers
- 108 people
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
Solid Tumor
ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors
An open, single-arm, multi-center Phase II clinical study of ENVAFOLIMAB single-agent treatment in patients with advanced solid tumors,to compare the overall response rate of TMB-high and TMB-Low,to determine the cut off value…
- Trial name
- NCT04891198
- Testing
- Envafolimab
- Where
- China
- Volunteers
- 126 people
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
Biliary Tract Neoplasms
Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers
This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients…
- Trial name
- NCT04910386
- Testing
- Envafolimab plus Gemcitabine&Cisplatin, Gemcitabine&Cisplatin
- Volunteers
- 126 people
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
Advanced or Metastatic Solid Tumors
This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy With Envafolimab in Patients With Advanced or Metastatic Solid Tumors.
This is an open label, two-part, multicenter, multi-regional phase I trial to investigate the safety, tolerability, and PK of KGX101 monotherapy and combination therapy with Envafolimab in patients with advanced or metastatic…
- Trial name
- NCT06074497
- Testing
- KGX101- Cohort -1, KGX101- Cohort 1, KGX101- Cohort 2
- Where
- 3 sites in Australia
- Volunteers
- 54 people
- Sponsor
- Kangabio AUSTRALIA LTD PTY
Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally…
- Trial name
- ENVASARC (NCT04480502)
- Testing
- Envafolimab, Ipilimumab
- Where
- 30 sites in United States, United Kingdom
- Volunteers
- 207 people
- Sponsor
- Tracon Pharmaceuticals Inc.
Non-small Cell Lung Cancer
Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
This is a randomized, controlled, double-blind, multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy…
- Trial name
- NCT06123754
- Testing
- Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection
- Where
- China
- Volunteers
- 390 people
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
Advanced or Metastatic Solid Tumors
A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients
This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients.
- Trial name
- NCT07260305
- Testing
- KGX101 injection, Envafolimab
- Where
- 3 sites in China
- Volunteers
- 57 people
- Sponsor
- Kangabio AUSTRALIA LTD PTY
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.