IBI188 Combination Therapy in Solid Tumors

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04861948

Collaborator

(none)

120

Enrollment

Location

Arms

17.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Phase Ib study aim to explore the efficacy, safety, and tolerability of IBI188 combination therapy in subjects with advanced malignancies

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors Lung Adenocarcinoma Osteosarcoma	Drug: IBI188 Drug: GM-CSF Drug: Cisplatin/Carboplatin Drug: Bevacizumab Drug: Sintilimab Drug: Pemetrexed	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase Ib Study to Evaluate the Efficacy, Safety and Tolerability of IBI188 Combination Therapy in Subjects With Advanced Malignancies

Actual Study Start Date :

May 25, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A	Drug: IBI188 intravenous Drug: Sintilimab intravenous
Experimental: Cohort B	Drug: IBI188 intravenous Drug: Cisplatin/Carboplatin intravenous Drug: Bevacizumab intravenous Drug: Pemetrexed intravenous
Experimental: Cohort C	Drug: IBI188 intravenous Drug: GM-CSF subcutaneous injection
Experimental: Cohort D	Drug: IBI188 intravenous Drug: Sintilimab intravenous

Outcome Measures

Primary Outcome Measures

Objective Response Rate [24 months]
Adverse Events [24 months]
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)

Secondary Outcome Measures

Progression-free survival [24 months]
Overall survival [24 months]
Disease control rate [24 months]
Duration of response [24 months]
Time to response [24 months]
Area Under Curve, AUC [24 months]
maximum concentration (Cmax) [24 months]
minimum concentration (Cmin) [24 months]
clearance (CL) [24 months]
volume of distribution (V) [24 months]
half-life (t1/2) [24 months]
Positive rate of anti-drug antibody (ADA) [24 months]
Positive rate of neutralizing antibody (NAb) [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with locally advanced or metastatic solid tumors cannot be cured by surgery or other local treatments .
Aged ≥ 18 years (≥ 12 years is acceptable in Cohort C).
Able to provide archived or fresh tumor tissue samples for biomarker assessment.
Have at least one measurable lesion according to RECIST version 1.1.
ECCG PS score of 0-2.
Adequate organ and bone marrow functions .
Life expectancy ≥ 12 weeks.
Female subjects of childbearing potential or male subjects with partners of childbearing potential should take effective contraceptive measures throughout the whole treatment period and until 6 months after treatment.
Must voluntarily sign the Informed Consent Form (ICF), and be able to follow all study requirements and procedures. For the subjects enrolled in Cohort C who are ≥ 12 and < 18 years old, in addition to obtaining the child's own consent, their guardians should provide informed consent and sign the ICF.

Exclusion Criteria:

Previous exposure to any CD47 antibody, SIRPα antibody, CD47/SIRPα recombinant protein or other inhibitors that act in the same pathway.
Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody (except Cohort C).
Concurrent participation in another clinical study.
The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.
Have undergone major surgical procedures within 4 weeks prior to the first dose of study treatment or planned to receive major surgery during the study treatment.
Presence of toxicities (excluding alopecia and fatigue) induced by previous anti-tumor therapy that has not recovered to Grade 0 or 1 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 prior to the first dose of study treatment.
Known hypersensitivity to IBI188 or any ingredient in the study drug product.
History of other primary malignancies.
Female subjects who are pregnant or lactating.
Other ineligible conditions considered by the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Medical University Cancer Institute and Hospital	Tianjin		China

Sponsors and Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

Investigators

Principal Investigator: Ba Yi, Tianjin Medical University Cancer Institute and Hospital
Principal Investigator: Zhang Dahong, Zhejiang Provincial People's Hospital
Principal Investigator: Guo Hongqian, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Principal Investigator: Fang Meiyu, Zhejiang Cancer Hospital
Principal Investigator: Xie Yu, Hunan Cancer Hospital
Principal Investigator: Liu Jisheng, First Affiliated Hospital of Soochow University
Principal Investigator: Wang Ying, Zhejiang Provincial People's Hospital
Principal Investigator: Wang Haiying, Shougang Hospital, Peking University
Principal Investigator: Wang Mengzhao, Shougang Hospital, Peking University
Principal Investigator: Lv Qiang, Jiangsu Provincial People's Hospital
Principal Investigator: Li Xiangping, Nanfang Hospital of Southern Medical University
Principal Investigator: Liu Guihong, The Affiliated Hospital of Xuzhou Medical University
Principal Investigator: Mou Weiqi, Chongqing University Cancer Hospital
Principal Investigator: Guo Wei, Peking Union Medical College
Principal Investigator: Wang Wei, Hunan Cancer Hospital
Principal Investigator: Xu Chongyuan, Nanfang Hospital of Southern Medical University