Clinical trial NCT04861948: IBI188 Combination Therapy in Solid Tumors
Official title: Phase Ib Study to Evaluate the Efficacy, Safety and Tolerability of IBI188 Combination Therapy in Subjects With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumors
Lung Adenocarcinoma
Osteosarcoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: 24 months
measure: Adverse Events
timeFrame: 24 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Disease control rate
timeFrame: 24 months
measure: Duration of response
timeFrame: 24 months
measure: Time to response
timeFrame: 24 months
measure: Area Under Curve, AUC
timeFrame: 24 months
measure: maximum concentration (Cmax)
timeFrame: 24 months
measure: minimum concentration (Cmin)
timeFrame: 24 months
measure: clearance (CL)
timeFrame: 24 months
measure: volume of distribution (V)
timeFrame: 24 months
measure: half-life (t1/2)
timeFrame: 24 months
measure: Positive rate of anti-drug antibody (ADA)
timeFrame: 24 months
measure: Positive rate of neutralizing antibody (NAb)
timeFrame: 24 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Ba Yi
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Provincial People's Hospital
name: Zhang Dahong
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Guo Hongqian
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Cancer Hospital
name: Fang Meiyu
role: PRINCIPAL_INVESTIGATOR
affiliation: Hunan Cancer Hospital
name: Xie Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Soochow University
name: Liu Jisheng
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Provincial People's Hospital
name: Wang Ying
role: PRINCIPAL_INVESTIGATOR
affiliation: Shougang Hospital, Peking University
name: Wang Haiying
role: PRINCIPAL_INVESTIGATOR
affiliation: Shougang Hospital, Peking University
name: Wang Mengzhao
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Provincial People's Hospital
name: Lv Qiang
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Li Xiangping
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Liu Guihong
role: PRINCIPAL_INVESTIGATOR
affiliation: Chongqing University Cancer Hospital
name: Mou Weiqi
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College
name: Guo Wei
role: PRINCIPAL_INVESTIGATOR
affiliation: Hunan Cancer Hospital
name: Wang Wei
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Xu Chongyuan
role: PRINCIPAL_INVESTIGATOR
References: