Clinical trials: Sintilimab, completed
NSCLC (Non-small-cell Lung Cancer)
IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Non-small-cell Lung Cancer (NSCLC)
This is an open label, multicenter, phase Ib study evaluating IBI310 (anti-CTLA-4) in combination with Sintilimab in patients with advanced, recurrent or metastatic non-small-cell lung cancer (NSCLC)
- Trial name
- NCT05118334
- Testing
- Sintilimab, IBI310
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Solid Tumor
A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced solid tumors
- Trial name
- NCT05119998
- Testing
- IBI325 + sintilimab, IBI325
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Advanced Renal Cell Carcinoma
Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)
The study consists of two parts, the first part is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy as…
- Trial name
- NCT05522231
- Testing
- fruquintinib+sintilimab, axitinib / everolimus, fruquintinib
- Where
- 48 sites in China
- Volunteers
- 265 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Advanced Lung Cancer
A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death…
- Trial name
- NCT04672356
- Testing
- IBI939, Sintilimab
- Where
- China
- Volunteers
- 19 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Healthy Male Subjects
Phase I Study of Sintilimab in Healthy Chinese Male Subjects
The purpose of this study is to evaluate the pharmacokinetic similarity of sintilimab with different manufacturing process in healthy male subjects.
- Trial name
- NCT05337267
- Testing
- sintilimab (after the change), sintilimab (before the change)
- Where
- China
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Advanced Malignancies
A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies
- Trial name
- NCT04353830
- Testing
- IBI939, IBI939+ Sintilimab
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Non-Squamous Non-Small Cell Lung Cancer
Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients will be investigated in this clinical trial.
- Trial name
- NCT03802240
- Testing
- Sintilimab, IBI305, Pemetrexed
- Where
- China
- Volunteers
- 492 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
SCLC
A Study of IBI110 in Combination With Sintilimab and Chemotherapy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
IBI110 is an investigational drug under evaluation for treatment of small cell lung cancer. The purpose of the study was to assess the Efficacy and Safety of IBI110 in combination with Sintilimab and chemotherapy with untreated…
- Trial name
- NCT05026593
- Testing
- Carboplatin, Cisplatin, Etoposide
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Advanced/Metastatic Solid Malignancies
IBI308 in Subjects With Advanced/Metastatic Solid Malignancies
The study is to evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies.
- Trial name
- NCT03568539
- Testing
- IBI308
- Where
- 7 sites in United States
- Volunteers
- 39 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Esophageal Squamous Cell Carcinoma
Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )
This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced…
- Trial name
- NCT03748134
- Testing
- Sintilimab, Cisplatin, Paclitaxel
- Where
- 48 sites in United States, Australia and 5 more
- Volunteers
- 746 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Advanced Cervical Cancer
A Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy
This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based…
- Trial name
- NCT04590599
- Testing
- IBI310, Sintilimab
- Where
- 2 sites in China
- Volunteers
- 205 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Solid Tumor, NSCLC
Afuresertib +Sintilimab+Chemotherapy in Patients With Selected Solid Tumors That Resistance to Prior Anti-PD-1/PD-L1
This is a multicenter, open-label, dose-escalation and efficacy/safety Phase I/II study to assess RP2D, safety, tolerability and anti-tumor activity of Sintilimab + afuresertib + nab-paclitaxel or docetaxel administered as a…
- Conditions
- Solid Tumor, NSCLC, Cervical Cancer, Endometrial Cancer
- Trial name
- NCT05383482
- Testing
- Afuresertib, Nab paclitaxel, Docetaxel
- Where
- 5 sites in China
- Volunteers
- 22 people
- Sponsor
- Laekna Limited
Advanced or Metastatic NSCLC
A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of…
- Trial name
- NCT04177290
- Testing
- Sintilimab (M1b), Sintilimab (approved)
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Advanced Solid Tumor
: A Phase Ib/II Study To Evaluate Fruquintinib Monotherapy Or Plus Sintilimab In Advanced Solid Tumors
This is a phase Ib/II study to evaluate the safety, tolerability, PK profile and preliminary efficacy of fruquintinib monotherapy or plus sintilimab for advanced solid tumors.
- Trial name
- NCT03903705
- Testing
- Fruquintinib in Combination with Sintilimab
- Where
- China
- Volunteers
- 348 people
- Sponsor
- Hutchmed
Advanced Solid Tumors
A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of single agent of IBI310, and in combination of sintilimab, in patients…
- Trial name
- NCT03545971
- Testing
- IBI310, Sintilimab
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Advanced Solid Tumor
First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors
Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in combination with Sintilimab in advanced solid tumor patients.
- Trial name
- NCT03758001
- Testing
- IBI101, Sintilimab
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Non-small Cell Lung Cancer
A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC
Clinical trial results demonstrate that anti-PD-1 antibodies prolonged OS to approximately 9 months compared with 6 months in docetaxel group.
- Trial name
- NCT03150875
- Testing
- IBI308, Docetaxel
- Where
- 2 sites in China
- Volunteers
- 290 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Tumor Infiltrating Lymphocytes, Safety
A Phase I Study of GC101 TIL in Advanced Solid Tumors
20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study.
- Conditions
- Tumor Infiltrating Lymphocytes, Safety, Advanced Solid Tumor, Immunotherapy
- Trial name
- MIZAR-001 (NCT05417750)
- Testing
- TIL therapy
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Shanghai Juncell Therapeutics
Cancer, Solid Tumor
First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors
The purpose of this study is to determine the safety, tolerability and efficacy of IBI308 monotherapy or in combination with chemotherapy in patients with certain types of advanced solid tumors.
- Trial name
- NCT02937116
- Testing
- IBI308, IBI308\Cisplatinum\Pemetrexed, IBI308\cisplatin\gemcitabine
- Where
- China
- Volunteers
- 233 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Advanced Lung Cancer
A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC
This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death…
- Trial name
- NCT04672369
- Testing
- IBI939, Sintilimab
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.