Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Arms 1: Neoadjuvant therapy group 20 patients Drug: Sintilimab Weight\<60Kg: 3mg/kg Q3W Weight\>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Perioperative Sintilimab+IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy .

Arms 2: first-line therapy group, 30 patients Drug: Sintilimab Weight\<60Kg: 3mg/kg Q3W Weight\>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.

Arms 3: ≥second-line therapy group, 30 patients Drug: Sintilimab Weight\<60Kg: 3mg/kg Q3W Weight\>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.

Sintilimab

Arms 1: Neoadjuvant therapy group, 20 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Perioperative Sintilimab+ IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy .

Arms 2: first-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.

Arms 3: ≥second-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.

IBI310

Lin Shen, professor

Zhi Peng, Associate Professor

Shen Lin, Professor

Shen Lin, professor

The purpose of this study is to evaluate the efficacy and safety of sintilimab+ IBI310 for EBV-Positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With EBV-Positive Gastric Cancer

Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With Gastric Cancer

Pathological complete regression (pCR):

Pathological complete regression (pCR) is defined as the proportion of patients with pathological complete regression (TRG1a) over the total number of patients evaluated centrally by the study pathologist

Objective response rate(ORR):

Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.

Number of participants experiencing clinical and laboratory adverse events (AEs).

( Number of participants experiencing clinical and laboratory adverse events (AEs).

Number of participants experiencing clinical and laboratory adverse events (AEs)

Innovent Biologics (Suzhou) Co. Ltd.

Peking University

MD,Professor,Chief of Department of GI Oncology,Peking University Cancer Hospital

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Surufatinib at a dose of 250mg QD, with Sintilimab injected intravenously 200mg per 3 weeks and IBI310 injected intravenously 1mg/kg per 6 weeks until disease progresses or unacceptable tolerability occurs

Sintilimab 200mg will be intravenously administered on Day 1 of each cycle

IBI310 1mg/kg be intravenously administered on Day 1 of every 2 cycle

Surufatinib 250mg will be taken orally once daily continuously

Surufatinib

Lin Shen

Lin Shen, Professor

Ming Lu, MD

This is a phase II, single arm, open-label, multicenter study to evaluate the efficacy and safety of Sintilimab combined with IBI310 and Surufatinib for the treatment of high-grade advanced-neuroendocrine neoplasm

The study population is about 40 patients with high-grade advanced-neuroendocrine neoplasm, who fails or cannot tolerate standard therapies. Surufatinib 250 mg once a day (QD) will be orally administrated, Sintilimab 200mg will be intravenously administered every 3 weeks and IBI310 1mg/kg will be intravenously administered every 6 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. For Sintilimab, the upper time limit for treatment is 2 years. The primary objective is objective response rate (ORR) of Sintilimab combined with IBI310 and Surufatinib in patients with advanced high-grade advanced-neuroendocrine neoplasm.

Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC

Sintilimab Combined With IBI310 and Surufatinib for the Treatment of High-grade Advanced-neuroendocrine Neoplasms: a Single Arm, Open-label, Multi Center, Phase II Study

The incidence of confirmed complete response or partial response

A duration from the date of initial treatment to disease progression or death of any cause

Duration from the first time reported partial response or complete response to the first time of disease progression or death

From the time of enrollment to death caused by any reason

From first dose to within 30 days after the last dose

To evaluate the relationship between the efficacy and tumor biomarkers of PD-L1

Clinical Professor

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Low-dose group:Participants will receive IBI310 0.3mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity.

Middle-dose group:Participants will receive IBI310 1.0mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity

Middle-dose group:Participants will receive IBI310 2.0mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity

High-dose group:Participants will receive IBI310 3.0mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity

3 subjects, low-dose group:Participants will receive IBI310 1.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.

low-dose group:Participants will receive IBI310 1.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.

3 subjects, low-dose group:Participants will receive IBI310 2.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.

low-dose group:Participants will receive IBI310 2.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.

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 with advanced solid tumors(Ia) and advanced melanoma(Ib).

Phase Ia study will adopt the classical 3+3 dose escalation design. The starting dose is 0.3 mg/kg, followed by 3 dose cohorts (1mg/kg, 2mg/kg and 3mg/kg). Duration of dose limiting toxicity (DLT) observation period is 21 days. IBI310 treatment q3w, up to 3 cycles, will be provided to patients who complete DLT observation period.

Efficacy will primarily be evaluated by RECIST v1.1. Patient safety will be monitored throughout the study. Pharmacokinetic/pharmacodynamics and immunogenicity will be assessed throughout the study.

Phase Ib study will evaluate the tolerability and safety of IBI310 combined with Sintilimab in patients with advanced melanoma. Phase Ib of the study will begin after DLT observation is completed in certain dose cohorts.

A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.

A Phase I, Open-Label Study to Investigate the Tolerability and Safety of IBI310 Alone or in Combination With Sintilimab in the Treatment of Patients With Advanced Solid Tumors.

Number of patients with treatment-related adverse events (AEs)

Maximum concentration(Cmax) of the drug after administration

Number of participants with anti-drug antibodies or neutralizing antibodies

The area under the curve (AUC) of serum concentration of the drug after the administration

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

IBI310 3 mg/kg,Q3W, for a total of 4 cycles

Placebo

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 chemotherapy

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

A Randomized, Double-blind, Controlled, Parallel-cohort 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

Objective response rate (ORR) assessed by the Independent Radiological Review Committee (IRRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1

ORR assessed by the investigator according to the RECIST V1.1

DCR assessed by the investigator and IRRC according to the RECIST V1.1

Biliary Tract Neoplasms

Biliary Tract Diseases

Biliary Tract Cancer

All Subjects will be treated with : Sintilimab 200mg IV Q3W continuously and IBI310 2mg/kg IV single dose, 3 weeks later, IBI310 maintenance dose is 1mg/kg IV Q6W until progression (treatment duration up to 24 months).

sintilimab

Tengfei Zhou

Tao Zhang

Jia Luo

This research study is designed to establish whether the combination of IBI310 \& Sintilimab has efficacy in patients with advanced BTC

IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer

A Single Arm,Multi-center,Phase Ib/II Clinical Study Evaluating IBI310 Combined With Sintilimab in Patients With Advanced Biliary Tract Cance(BTC)

Investigator evaluated ORR per RECIST V1.1

PFS is defined as the time from first treatment to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1), or death due to any cause.

Defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first;

Defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD

OS is defined as the time from enrollment to the date of death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With EBV-Positive Gastric Cancer	NCT04202601	Advanced Gastri...	Sintilimab IBI310	18 Years -	Peking University
Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With EBV-Positive Gastric Cancer	NCT04202601	Advanced Gastri...	Sintilimab IBI310	18 Years -	Peking University
Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With EBV-Positive Gastric Cancer	NCT04202601	Advanced Gastri...	Sintilimab IBI310	18 Years -	Peking University
Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC	NCT05165407	Neuroendocrine ...	Sintilimab IBI310 Surufatinib	18 Years - 75 Years	Peking University
A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.	NCT03545971	Advanced Solid ...	IBI310 Sintilimab	18 Years - 70 Years	Innovent Biologics (Suzhou) Co. Ltd.
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	NCT04590599	Advanced Cervic...	IBI310 Placebo Sintilimab	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer	NCT05653180	Advanced Biliar...	IBI310 sintilimab	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.

Spots Global Cancer Trial Database for ibi310

Every month we try and update this database with for ibi310 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ibi310

Every month we try and update this database with for ibi310 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ibi310 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.