IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks.

IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Subjects will receive study medication until disease progression, toxicity intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any other reason that requires discontinuation of the study treatment, whichever occurs first.

IBI363

Saqib Abbasi

This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.

A Study of IBI363 in Subjects With Advanced Solid Malignancies

A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies

Innovent Biologics (Suzhou) Co. Ltd.

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Lenvatinib

Methotrexate

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients with histopathologically confirmed advanced melanoma, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC.

Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC.

Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-L1 treatment was disease stabilization for less than 6 months or disease progression.

Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-L1 treatment was partial response or complete response lasting more than 6 months.

Patients with histologically confirmed advanced NSCLC, who have undergone NGS testing confirming the presence of an ALK fusion mutation and have previously failed standard treatment.

Patients with histological or cytological confirmation of advanced NSCLC who harboring EGFR mutation and failed standard treatment.

Patients with histological or cytological confirmation of advanced NSCLC and failed standard treatment with rare mutations, including but not limited to ROS1, BRAF V600E, METex14 skipping, HER2, NTRK, and RET fusion.

IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.

IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.

IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.

IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.

The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).

Yongchang Zhang, MD

Nong Yang, MD

Yongchang Yongchang Zhang, MD

Yongchang Zhang

Nong Yang

Xiang Chen

Hong Liu

The study is a prospective multi-cohort clinical study. The study is divided into two phases, Phase Ia and Phase Ib. In Phase Ia, a dose escalation portion was conducted using a 3+3 dose-escalation design, with a preference for enrolling subjects with advanced non-small cell lung cancer and melanoma. Phase Ib represents the cohort expansion phase, comprising seven cohorts.

The study is a prospective multi-cohort clinical study. The study is divided into two phases, Phase Ia and Phase Ib. In Phase Ia, a dose escalation portion was conducted using a 3+3 dose-escalation design, with a preference for enrolling subjects with advanced non-small cell lung cancer and melanoma. Phase Ib represents the cohort expansion phase, comprising seven cohorts. All the research data were collected follow the SAP.

The Efficacy and Safety of IBI363 in Solid Tumors

A Prospective, Multi-cohort Study on Efficacy and Safety of IBI363 for Advanced Solid Tumors

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

Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects

Xiangya Hospital of Central South University

Hunan Province Tumor Hospital

Professor, Deputy Director of Thoracic Oncology Department

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antibodies

Immunoglobulins

a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.

Xiuzhi Yu

Tingbo Liang

This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D).

This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D). The phase Ia part consists of the dose escalation and PD marker exploration part. The phase Ib part consists of the dose expansion part.

Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma

A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma

Incidence of dose-limiting toxicity (DLT) events

AE is defined as an unexpected medical problem that happens during treatment with a drug or other therapy. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.

Blood pressure, pulse, respiratory rate, and temperature will be assessed.

Blood samples will be collected to evaluate hemoglobin, white blood cell (WBC) count, platelets and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT)

Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or blood urea nitrogen (BUN), bicarbonate, amylase, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, lactate dehydrogenase and lipase.

Urine samples will be collected to evaluate specific gravity, leucocyte esterase, nitrite, blood, bilirubin, protein, glucose, ketones and urobilinogen.

12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.

PK parameters to be evaluated for IBI363 including maximum concentration (Cmax) will be determined when appropriate.

PK parameters to be evaluated for IBI363 including area under the curve (AUC) will be determined when appropriate.

PK parameters to be evaluated for IBI363 including clearance (CL) will be determined when appropriate.

PK parameters to be evaluated for IBI363 including half-life (t1/2) will be determined when appropriate.

PK parameters to be evaluated for IBI363 including volume of distribution (V) will be determined when appropriate.

To evaluate the preliminary antitumor activity of IBI363

Each subject will be tested for anti-drug (IBI363) antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb).

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Haiyun Zuo

Jun Guo

This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients

A Study of IBI363 in Subjects With Advanced Melanoma

A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma

Min Luo

Morteza Aghmesheh

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 sequential doses of IBI363 (study drug) in subjects with advanced, refractory 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

An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.

Blood samples will be collected to evaluate hemoglobin, mean corpuscular volume (MCV), white blood cell (WBC) count, platelets, 5-part differential white cell count, mean platelet volume and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of IBI363 in Subjects With Advanced Solid Malignancies	NCT06281678	Solid Tumors	IBI363	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
The Efficacy and Safety of IBI363 in Solid Tumors	NCT06081907	Advanced Solid ...	IBI363 IBI363 IBI363 IBI363 IBI363	18 Years - 75 Years	Hunan Province Tumor Hospital
Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma	NCT05460767	Solid Tumors or...	IBI363	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
A Study of IBI363 in Subjects With Advanced Melanoma	NCT06081920	Melanoma	IBI363	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas	NCT05290597	Solid Malignanc...	IBI363	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.

Spots Global Cancer Trial Database for ibi363

Every month we try and update this database with for ibi363 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 ibi363

Every month we try and update this database with for ibi363 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 ibi363 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.