IBI188 Combination Therapy in Solid Tumors

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04861948
• Other study ID #: CIBI188A104
• Status: Terminated
• Phase: Phase 1
• Start date: May 25, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: October 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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, SIRPa antibody, CD47/SIRPa 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.

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Lung Adenocarcinoma
• Osteosarcoma
• Solid Tumors

Intervention

Drug:
• IBI188
intravenous
• GM-CSF
subcutaneous injection
• Cisplatin/Carboplatin
intravenous
• Bevacizumab
intravenous
• Sintilimab
intravenous
• Pemetrexed
intravenous

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		24 months
Primary	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	Progression-free survival		24 months
Secondary	Overall survival		24 months
Secondary	Disease control rate		24 months
Secondary	Duration of response		24 months
Secondary	Time to response		24 months
Secondary	Area Under Curve, AUC		24 months
Secondary	maximum concentration (Cmax)		24 months
Secondary	minimum concentration (Cmin)		24 months
Secondary	clearance (CL)		24 months
Secondary	volume of distribution (V)		24 months
Secondary	half-life (t1/2)		24 months
Secondary	Positive rate of anti-drug antibody (ADA)		24 months
Secondary	Positive rate of neutralizing antibody (NAb)		24 months