Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

IBI939

Sintilimab

Ying Cheng

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 receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.

A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC

An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer

Proportion of subjects with complete response(CR) or partial response(PR).

The time from randomization to the first occurrence of objective disease progression or death

The time from randomization to death due to any cause.

Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).

The time from the first documented objective tumor response(CR or PR) to objective disease progression (PD) or death.

Time from randomization to first objective tumor response (CR or PR).

Innovent Biologics (Suzhou) Co. Ltd.

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Participants will be treated with escalating doses of IBI939 to determine the MTD.

Participants will be treated with escalating doses of IBI939 in combination with a fixed dose of Sintilimab to determine the MTD.

Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI939 in combination with Sintilimab in different cancer types.

Several dose levels will be evaluated for IBI939 administered as a single agent and in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI939 may receive combination treatment with Sintilimab or IBI939+ Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit.

IBI939: Several dose levels will be evaluated for IBI939 in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit.

IBI939+ Sintilimab

IBI939: IBI939 in combination with Sintilimab will be given with RP2D. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit.

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

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

A Phase 1a, Open-label, Dose-Escalation Study to Evaluate 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

To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab \[Adverse events (AEs), Serious Adverse Events (SAEs) \]

To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab.

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

Maximum concentration (Cmax) of the drug after administration

Immunogenicity: Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI939.

Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors.

IBI939 10mg/kg combination with Sintilimab

IBI939 20mg/kg combination with Sintilimab

A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer

Proportion of subjects with complete response (CR) or partial response (PR).

The time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC	NCT04672369	Advanced Lung C...	IBI939 Sintilimab	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
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	NCT04353830	Advanced Malign...	IBI939 IBI939+ Sintili... IBI939+ Sintili...	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer	NCT04672356	Advanced Lung C...	IBI939 Sintilimab	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.

Spots Global Cancer Trial Database for ibi939

Every month we try and update this database with for ibi939 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 ibi939

Every month we try and update this database with for ibi939 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 ibi939 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.