Phase Ia is an open, non-random, single-arm dose escalation design.

Acceleration Stage: The initial increasing dose is 0.025 mg/kg, and the dose is increased in 100% increments. Each dose group will enroll 1 subject.

Phase Ia is an open, non-random, single-arm dose escalation design.

3+3 Stage: The dose is increased in 30%-50% increments between adjacent dose groups, and the increment is determined by the investigator and the sponsor based on the safety data obtained in the previous period.Each dose group will enroll 3 to 6 evaluable subjects (evaluable: at least complete the DLT observation period), and this period continues until the maximum tolerated dose (MTD) is reached.

Phase Ib is an open, non-random, single-arm, multi-center research design.

When phase Ia is transformed into 3+3 stage, a certain dose group meets the conditions for increasing the next dose group (after the DLT observation period of the last subject in the dose group has passed, the safety assessment of the current dose group will be completed) , The dose extension study of this dose group can be carried out, and 6 evaluable (evaluable: at least 2 cycles of dosing and observation) subjects with advanced malignant tumors who have failed standard treatments will be included in this dose group.

The Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design.

Group A: Recurrent or metastatic triple-negative breast cancer that failed standard treatment.

The Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design.

Group B: Locally advanced/metastatic non-small cell lung cancer without driver gene mutations that failed standard treatment.

The Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design.

Group C: Recurrent or metastatic head and neck squamous cell carcinoma that failed standard treatment.

The Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design.

Group D: Recurrent or metastatic peripheral T-cell lymphoma that failed standard treatment.

IBC0966

tie xu

Qingyuan Zhang

This is a phase I/IIa study to evaluate the safety, tolerability and efficacy of IBC0966 for the treatment of subjects with advanced malignant tumors.

The study includes three phases: dose escalation (Phase Ia), dose extension (Phase Ib), and clinical exploration (Phase IIa).

First, the Phase Ia dose escalation will be carried out. After switching to the 3+3 escalation mode, the Phase Ib dose extension study can be carried out at the same time. After Phase Ia is completed and RP2D is obtained, Phase IIa clinical exploratory research can be carried out.

Clinical Trial of IBC0966 in Patients With Advanced Malignant Tumors

A Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of IBC0966 in Patients With Advanced Malignant Tumors

To investigate the safety characteristics.

To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).

To explore the clinical effectiveness. Tumor response based on RECIST 1.1 or Lugano 2014.

PK parameters (Cmax) following single dose.

PK parameters (Tmax) following single dose.

PK parameters (AUC 0-t ) following single dose.

PK parameters (AUC 0-∞) following single dose.

PK parameters (t1/2) following single dose.

PK parameters (λz) following single dose.

PK parameters (Css,max) following single dose.

PK parameters (Css,min) following single dose.

PK parameters (AUCss) following single dose.

Tumor response based on RECIST 1.1 or Lugano 2014.

The frequency of anti-drug antibodies (ADA) against IBC0966.(Phase Ⅰ)

PFS as assessed using RECIST 1.1 or Lugano 2014.

OS as assessed using RECIST 1.1 or Lugano 2014.

DCR as assessed using RECIST 1.1 or Lugano 2014.

The frequency of anti-drug antibodies (ADA) against IBC0966.(Phase Ⅱa)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Trial of IBC0966 in Patients With Advanced Malignant Tumors	NCT04980690	Advanced Malign...	IBC0966	18 Years - 75 Years	SUNHO（China）BioPharmaceutical CO., Ltd.
Clinical Trial of IBC0966 in Patients With Advanced Malignant Tumors	NCT04980690	Advanced Malign...	IBC0966	18 Years - 75 Years	SUNHO（China）BioPharmaceutical CO., Ltd.

Spots Global Cancer Trial Database for ibc0966

Every month we try and update this database with for ibc0966 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 ibc0966

Every month we try and update this database with for ibc0966 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 ibc0966 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.