Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphosarcoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Part 1: Accelerated Titration Phase 0.1 mg/kg IV; QW 0.3 mg/kg IV QW; 1 mg/kg IV QW

Part 2 : Dose Escalation Phase with initial fixed priming dose Priming dose of 1mg/kg on C1D1 followed by 3 mg/kg IV QW; 10 mg/kg IV QW; 20 mg/kg IV QW; 30 mg/kg IV QW.

The study is composed of two stages: Part 1 Accelerated Titration Phase and Part 2 Dose Escalation Phase with initial fixed priming dose.

The starting dose for part 1 is 0.1 mg/kg QW, followed by 2 dose cohorts (0.3 mg/kg QW and 1 mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 28 days.

Part 2 will have 4 dose cohorts(3mg/kg QW、10mg/kg QW、20mg/kg QW and 30mg/kg QW). Conventional 3+3 Dose Escalation will be adopted. DLT observation period is 28 days.

IBI188

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy in patients with advanced malignancies.

A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignant Tumors and Lymphomas

A Phase 1a Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignant Tumors and Lymphomas

To evaluate the safety and tolerability of IBI188 \[Adverse events (AEs), Serious Adverse Events (SAE) \]

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

Maximum concentration(Cmax) of the drug after administration

Number of Anti-Drug Antibodies (ADA) positive patients will be counted and percentage of ADA positive patients will be calculated to evaluate immunogenicity of IBI188.

Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by iRECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma.

Innovent Biologics (Suzhou) Co. Ltd.

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

Azacitidine

Decitabine

Antimetabolites

Enzyme Inhibitors

1L unfit AML receive IBI188 every week by intravenous(IV) and azacitidine daily in Day 1-7 of each four weeks(Q4W) by subcutaneous(IH)

R/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH)

The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia

Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia

A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Demethylating Agents in Subjects With Acute Myeloid Leukemia

Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery

Part A : Initial dose escalation, Part B : Maintenance dose escalation

Part A: 0.1 mg/kg IV QW, 0.3 mg/kg IV QW, 1 mg/kg IV QW. Part B: 1mg/kg IV D1+3, 10, 20, 30 mg/kg IV D8 QW or 45mg/kg D8 IV Q3W.

Song Yuqin

Phase Ia study is composed of two stages: Phase Ia Part A initial dose escalation and Phase Ia Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design. The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 2 dose cohorts (0.3 mg/kg QW and 1 mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.

Phase Ia Part B will have 4 dose cohorts(3mg/kg QW#10mg/kg QW#20mg/kg QW #30mg/kg QW and 45mg/kg Q3W). DLT observation period is 28 days. The subject number for each cohort in Phase Ia Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6

A Phase 1 Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI188 in Advanced Malignancies

A Phase 1 Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignancies

Incidence, correlation with the study drug and severity of all adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs) and serious adverse events (SAEs).

Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma.

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

Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of IBI188.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignant Tumors and Lymphomas	NCT03763149	Advanced Malign...	IBI188	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia	NCT04485052	Acute Myeloid L...	IBI188 Azacitidine Decitabine	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
A Phase 1 Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI188 in Advanced Malignancies	NCT03717103	Advanced Malign...	IBI188	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignant Tumors and Lymphomas	NCT03763149	Advanced Malign...	IBI188	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.

Spots Global Cancer Trial Database for ibi188

Every month we try and update this database with for ibi188 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 ibi188

Every month we try and update this database with for ibi188 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 ibi188 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.