Clinical trials: sponsored by Innovent Biologics (Suzhou) Co. Ltd.
Healthy Participants
A Mutiple-dose Study of IBI3033 in Healthy Participants
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3033 in Chinese healthy participants.
- Trial name
- NCT07456839
- Testing
- IBI3033
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Healthy Participants
A First-in-human, Single-ascending-dose Study of IBI3033 in Healthy Participants
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3033 in Chinese healthy participants.
- Trial name
- NCT07311226
- Testing
- IBI3033
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Healthy Volunteers
A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers
This study is a multicenter, randomized, double-masked, parallel-group, reference-drug-controlled clinical trial of IBI3027 in healthy male volunteers.
- Trial name
- NCT07502534
- Testing
- IBI3027, DUPIXENT® (dupilumab)
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (G-HOPE-001)
This is a Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects with Previously Treated Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced…
- Trial name
- G-HOPE-001 (NCT06238843)
- Testing
- Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）, IBI343
- Where
- 95 sites in China, Japan
- Volunteers
- 464 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Overweight, Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）
This is a multicenter, randomized, open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 9 mg QW versus Semaglutide 2.4 mg QW in overweight or obese (BMI≥27kg/m2) MAFLD subjects.
- Trial name
- NCT06884293
- Testing
- IBI362, semaglutide
- Where
- China
- Volunteers
- 479 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Lung Neoplasms
Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC
Efficacy and Safety Evaluation of IBI308 in Patients with advanced or metastatic Non-squamous NSCLC
- Trial name
- NCT03607539
- Testing
- Sintilimab, Pemetrexed, Platinum
- Where
- China
- Volunteers
- 397 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Locally Advanced Unresectable or Metastatic Solid Tumors
A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
This is a Phase Ia/Ib, multicenter, open-label, first-in-human study to evaluate the safety, tolerability, PK, and efficacy of IBI343 in participants with locally advanced unresectable or metastatic solid tumors.
- Trial name
- NCT05458219
- Testing
- IBI343, FOLFIRINOX/mFOLFIRINOX, mFOLFOX
- Where
- 39 sites in United States, Australia and 1 more
- Volunteers
- 470 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Thyroid Eye Disease, TED
A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease
A multicenter, open-label extension study evaluating the efficacy and safety of IBI311 in subjects with thyroid eye disease
- Trial name
- NCT06126783
- Testing
- IBI311
- Where
- China
- Volunteers
- 91 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Healthy, Active Non-segmental Vitiligo
Study to Evaluate the Safety, Tolerability and How IBI3013 is Taken up and Processed by the Body in Healthy Volunteers After Single-dose Administration, and in Non-segmental Vitiligo Patients and Alopecia Areata Patients After Multiple-dose Administration
A multicenter clinical study to evaluate the safety, PK characteristics, immunogenicity characteristics, and PD characteristics of IBI3013 in healthy trial participants and active non-segmental vitiligo trial participants and…
- Conditions
- Healthy, Active Non-segmental Vitiligo, Severe Alopecia Areata
- Trial name
- NCT07554222
- Testing
- Baricitinib tablets, IBI3013
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Atopic Dermatitis
A Study of IBI3033 in Moderate-to-Severe Atopic Dermatitis
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, and pharmacokinetics of IBI3033 in subjects with moderate-to-severe atopic dermatitis…
- Trial name
- NCT07549984
- Testing
- IBI3033
- Where
- China
- Volunteers
- 16 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Colorectal Neoplasms
SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cancer
This phase II trial studies how well stereotactic body radiotherapy (SBRT) followed by a combination of an immune checkpoint inhibitor (sintilimab), bevacizumab, and trifluridine/tipiracil (TAS-102) works as third-line treatment…
- Trial name
- BEST (NCT07535632)
- Testing
- SBRT, Sintilimab, Bevacizumab
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Shanghai Zhongshan Hospital
Hepato Cellular Carcinoma (HCC)
TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk
Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide. The recurrence rate after curative resection for early-stage HCC remains extremely high, with 2-year and 5-year recurrence rates…
- Trial name
- ACTION-001 (NCT07487662)
- Testing
- sintilimab, ipilimumab N01, Lenvatinib
- Volunteers
- 105 people
- Sponsor
- Sun Yat-sen University
Colorectal Cancer, Gastric Cancer
Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
This is a Phase 1 open-label, non-randomized, multi-center clinical trial of intratumoral IVX037 as monotherapy and in combination with an immune checkpoint inhibitor in patients with advanced micro satellite-stable (MSS)…
- Conditions
- Colorectal Cancer, Gastric Cancer, Ovarian Cancer
- Trial name
- NCT05427487
- Testing
- IVX037, Sintilimab
- Where
- 3 sites in Australia
- Volunteers
- 70 people
- Sponsor
- ImmVirx Pty Ltd
Resectable NSCLC, KRAS G12C Mutation
Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC
This is an exploratory study evaluating the efficacy and safety of neoadjuvant therapy with fulzerasib sequentially combined with sintilimab plus platinum-doublet chemotherapy in patients with resectable non-small cell lung…
- Conditions
- Resectable NSCLC, KRAS G12C Mutation, Stage IB-IIIA NSCLC, Neoadjuvant Therapy
- Trial name
- K-NADIR (NCT07492342)
- Testing
- fulzerasib
- Where
- 3 sites in China
- Volunteers
- 30 people
- Sponsor
- Jianxing He
Hepatocellular Carcinoma
A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC
This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib in patients with locally advanced or metastatic HCC who have not…
- Trial name
- NCT04720716
- Testing
- IBI310, Sintilimab, Sorafenib
- Where
- China
- Volunteers
- 344 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Lung Cancer (Non-Small Cell)
IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
Study Design: a Phase II, single-arm, multicenter, prospective, interventional study. Target Population: Subjects with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to harbor…
- Trial name
- NCT07198841
- Testing
- IBI351 combined with cetuximab β
- Where
- 7 sites in China
- Volunteers
- 48 people
- Sponsor
- Guangdong Association of Clinical Trials
Atopic Dermatitis
A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis
This is a multi-center, randomized, double-blind, parallel, placebo-controlled phase 2 clinical study. A total of 403 adult participants with moderate to severe AD are planned to be enrolled to evaluate efficacy, safety, PK…
- Trial name
- NCT07330934
- Testing
- Dupilumab, IBI356
- Where
- China
- Volunteers
- 403 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Solid Malignancies or Lymphomas
A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas
This is a Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of…
- Trial name
- NCT05290597
- Testing
- IBI363
- Where
- 4 sites in Australia
- Volunteers
- 40 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Lung Cancer (NSCLC), Leptomeningeal Metastasis
Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC
This is a prospective, single-arm, phase Ia clinical study, which was designed to evaluate the efficacy and safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC.
- Trial name
- NCT06663306
- Testing
- Pemetrexed, Bevacizumab
- Where
- China
- Volunteers
- 19 people
- Sponsor
- Shanghai Chest Hospital
Cancer of Unknown Primary Site
Sintilimab in Cancer of Unknown Primary
This is a Phase 2 clinical trial evaluating the efficacy and safety of sintilimab in subjects with CUP. Up to 45 subjects with CUP will be enrolled.
- Trial name
- NCT05024968
- Testing
- Sintilimab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- M.D. Anderson Cancer Center