IBI188 Combination Therapy in Solid Tumors
Phase 1
Terminated
- Conditions
- OsteosarcomaSolid TumorsLung Adenocarcinoma
- Interventions
- Drug: Cisplatin/Carboplatin
- Registration Number
- NCT04861948
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Brief Summary
A Phase Ib study aim to evaluate the efficacy, safety, and tolerability of IBI188 combination therapy in subjects with advanced malignancies
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort C IBI188 - Cohort A IBI188 - Cohort B Bevacizumab - Cohort B IBI188 - Cohort B Cisplatin/Carboplatin - Cohort B Pemetrexed - Cohort D Sintilimab - Cohort D IBI188 - Cohort A Sintilimab - Cohort C GM-CSF -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Overall survival 24 months clearance (CL) 24 months Area Under Curve, AUC 24 months Disease control rate 24 months Time to response 24 months Progression-free survival 24 months Positive rate of neutralizing antibody (NAb) 24 months Duration of response 24 months maximum concentration (Cmax) 24 months minimum concentration (Cmin) 24 months volume of distribution (V) 24 months half-life (t1/2) 24 months Positive rate of anti-drug antibody (ADA) 24 months
Trial Locations
- Locations (1)
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, China