IBI188 Combination Therapy in Solid Tumors

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

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

Study Overview

• Status: Terminated
• Conditions: Osteosarcoma; Lung Adenocarcinoma; Solid Tumors
• Intervention / Treatment: Drug: IBI188; Drug: Sintilimab; Drug: Cisplatin/Carboplatin; Drug: Bevacizumab; Drug: Pemetrexed; Drug: GM-CSF

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with locally advanced or metastatic solid tumors cannot be cured by surgery or other local treatments .
2. Aged ≥ 18 years (≥ 12 years is acceptable in Cohort C).
3. Able to provide archived or fresh tumor tissue samples for biomarker assessment.
4. Have at least one measurable lesion according to RECIST version 1.1.
5. ECCG PS score of 0-2.
6. Adequate organ and bone marrow functions .
7. Life expectancy ≥ 12 weeks.
8. 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.
9. 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:

1. Previous exposure to any CD47 antibody, SIRPα antibody, CD47/SIRPα recombinant protein or other inhibitors that act in the same pathway.
2. Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody (except Cohort C).
3. Concurrent participation in another clinical study.
4. The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.
5. 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.
6. 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.
7. Known hypersensitivity to IBI188 or any ingredient in the study drug product.
8. History of other primary malignancies.
9. Female subjects who are pregnant or lactating.
10. Other ineligible conditions considered by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate		24 months
Adverse Events	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)	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	24 months
Overall survival	24 months
Duration of response	24 months
Disease control rate	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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2021
• Primary Completion (ACTUAL): July 30, 2022
• Study Completion (ACTUAL): July 30, 2022

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 24, 2021
• First Posted (ACTUAL): April 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma; Osteosarcoma; Adenocarcinoma of Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Folic Acid Antagonists; Carboplatin; Cisplatin; Bevacizumab; Pemetrexed
• Other Study ID Numbers: CIBI188A104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No