0.3 mg intravenous infusion, C1D1 and afterwards Q2W

IBI318

1 mg intravenous infusion, C1D1 and afterwards Q2W

3 mg intravenous infusion, C1D1 and afterwards Q2W

10 mg intravenous infusion, C1D1 and afterwards Q2W

30 mg intravenous infusion, C1D1 and afterwards Q2W

100 mg intravenous infusion, C1D1 and afterwards Q2W

300 mg intravenous infusion, C1D1 and afterwards Q2W

600 mg intravenous infusion, C1D1 and afterwards Q2W

Intravenous infusion, C1D1 and afterwards Q3W

An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.

Study of IBI318 in Participants With Advanced Malignancies

To Evaluate the Safety, Tolerability, and Initial Efficacy of IBI318 in Patients With Advanced Malignancy, Multicenter, IA/IB Study

Innovent Biologics (Suzhou) Co. Ltd.

Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks.

IBI318 will be given fixed dose via intravenous (IV) infusion on Day 1 of each 14-day cycle until disease progression or loss of clinical benefit.

The purpose of this study is to evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation.

Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

A Phase Ib/II, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of IBI318 in Participants With Advanced Cutaneous Squamous Cell Carcinoma.

RECIST version 1.1 will be used to determine ORR by IRRC

RECIST version 1.1 will be used to determine ORR by investigator

RECIST version 1.1 will be used to determine DOR by investigator and IRRC

RECIST version 1.1 will be used to determine PFS by investigator and IRRC

To evaluate the safety and tolerability of IBI318 \[Adverse events (AEs), Serious Adverse Events (SAEs) \]

Digestive System Diseases

Carcinoma, Hepatocellular

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Chlorotrianisene

before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W

conventional transarterial chemoembolization

cTACE

before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W

placebo

The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma.

A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma

A Phase Ib Study to Evaluate the Safety and Efficacy of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

paclitaxel

Ying Cheng, Ph.D

This study is a phase Ib/III clinical study to evaluate the efficacy and safety of recombinant fully human anti-programmed cell death receptor 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) bispecific antibody injection (IBI318) in combination with paclitaxel versus placebo in combination with paclitaxel in subjects with small cell lung cancer who have failed first-line or above chemotherapies.

A Phase Ib/III Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies

A Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies

The incidence rate of all treatment-emergent adverse events (TEAEs), immune-related adverse events (irAEs) and serious adverse events (SAEs), treatment-related adverse events (TRAEs) and the severity.

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

For subjects with CR or PR, it is defined as the time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death.

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

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

Defined as the time from randomization to the first occurrence of objective disease progression or death.

Defined as the time from randomization to death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of IBI318 in Participants With Advanced Malignancies	NCT03875157	Advanced Malign...	IBI318 IBI318 IBI318 IBI318 IBI318 IBI318 IBI318 IBI318 IBI318 IBI318 IBI318	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma	NCT04611321	Advanced Cutane...	IBI318	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma	NCT04635527	Hepatocellular ...	IBI318 cTACE placebo	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
Study of IBI318 in Participants With Advanced Malignancies	NCT03875157	Advanced Malign...	IBI318 IBI318 IBI318 IBI318 IBI318 IBI318 IBI318 IBI318 IBI318 IBI318 IBI318	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
A Phase Ib/III Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies	NCT04672928	Small Cell Lung...	paclitaxel IBI318	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.

Spots Global Cancer Trial Database for ibi318

Every month we try and update this database with for ibi318 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 ibi318

Every month we try and update this database with for ibi318 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 ibi318 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.