Back to results

IBI188 Combination Therapy in Solid Tumors

Primary Purpose

Solid Tumors, Lung Adenocarcinoma, Osteosarcoma

Status

Terminated

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

IBI188

GM-CSF

Cisplatin/Carboplatin

Bevacizumab

Sintilimab

Pemetrexed

About this trial

This is an interventional treatment trial for Solid Tumors

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Tianjin Medical University Cancer Institute and Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort A

Cohort B

Cohort C

Cohort D

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate

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)

Secondary Outcome Measures

Progression-free survival

Overall survival

Disease control rate

Duration of response

Time to response

Area Under Curve, AUC

maximum concentration (Cmax)

minimum concentration (Cmin)

clearance (CL)

volume of distribution (V)

half-life (t1/2)

Positive rate of anti-drug antibody (ADA)

Positive rate of neutralizing antibody (NAb)

Full Information

NCT ID

NCT04861948

First Posted

April 22, 2021

Last Updated

October 3, 2022

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04861948

Brief Title

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Terminated

Why Stopped

No signs of efficacy in solid tumors

Study Start Date

May 25, 2021 (Actual)

Primary Completion Date

July 30, 2022 (Actual)

Study Completion Date

July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Solid Tumors, Lung Adenocarcinoma, Osteosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A

Arm Type

Experimental

Arm Title

Cohort B

Arm Type

Experimental

Arm Title

Cohort C

Arm Type

Experimental

Arm Title

Cohort D

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

IBI188

Intervention Description

intravenous

Intervention Type

Drug

Intervention Name(s)

GM-CSF

Intervention Description

subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Cisplatin/Carboplatin

Intervention Description

intravenous

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

intravenous

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Intervention Description

intravenous

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

intravenous

Primary Outcome Measure Information:

Title

Objective Response Rate

Time Frame

24 months

Title

Adverse Events

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Progression-free survival

Time Frame

24 months

Title

Overall survival

Time Frame

24 months

Title

Disease control rate

Time Frame

24 months

Title

Duration of response

Time Frame

24 months

Title

Time to response

Time Frame

24 months

Title

Area Under Curve, AUC

Time Frame

24 months

Title

maximum concentration (Cmax)

Time Frame

24 months

Title

minimum concentration (Cmin)

Time Frame

24 months

Title

clearance (CL)

Time Frame

24 months

Title

volume of distribution (V)

Time Frame

24 months

Title

half-life (t1/2)

Time Frame

24 months

Title

Positive rate of anti-drug antibody (ADA)

Time Frame

24 months

Title

Positive rate of neutralizing antibody (NAb)

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: