Study of IBI318 in Participants With Advanced Malignancies

Phase 1

Completed

• Conditions: Advanced Malignancy
• Interventions: Biological: IBI318

• Registration Number: NCT03875157
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.

Detailed Description

An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.

Study Timeline

• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Study Start: 2019-04-19
• Status Verified: 2023-02
• Primary Completion: 2023-02-16
• Study Completion: 2023-02-16
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1. Sign the informed consent form
2. Men or women 18 years or older
3. Expected survival time ≥ 12 weeks
4. Tumor assessment according to RECIST v1.1, at least one measurable lesion
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Have adequate organ and bone marrow function
7. Male participants and female participants must agree to use contraception during the treatment period and within 180 days after the treatment period
8. Female subjects must not be pregnant or breastfeeding. If premenopausal, negative urine or serum pregnancy tests are required
9. Ia: Subjects with locally advanced, recurrent or metastatic histologically or cytologically confirmed solid tumors or hematologic tumors and are refractory or intolerant to existing standard treatments
10. Ib: Metastatic non-small cell lung cancer, advanced liver cancer, advanced esophageal squamous cell cancer, advanced gastric cancer, or other tumors that have been proved by histology or cytology with initial therapeutic effect in Phase Ia

Exclusion Criteria

1. Previous exposure to immunotherapy including but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anti-tumor vaccine
2. Participation in another interventional clinical study, an observational (non-interventional) clinical study, or a follow-up phase of an interventional study
3. Receive last anti-tumor treatment within 4 weeks prior to the first dose of study drug
4. Use of immunosuppressive drugs within 4 weeks prior to the first dose of study drug
5. Require long-term steroid therapy or any other form of immunosuppressive therapy not including inhaled steroids
6. Toxicity (excluding hair loss or fatigue) caused by previous antitumor therapy that did not recover to NCI CTCAE v 5.0 level 0-1 within 4 weeks prior to the first dose of study drug
7. Received major surgery or has unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose of study drug
8. Expect to receive other anti-tumor treatments during study (allowing palliative radiotherapy)
9. History of infectious pneumonitis that required steroids or has current pneumonitis
10. Known active untreated CNS metastases and/or spinal cord compression and/or cancerous meningitis, or with a history of soft meningeal cancer
11. Active autoimmune disease that has required systemic treatment in past 2 years
12. Known active Hepatitis B or Hepatitis C virus
13. Uncontrolled concomitant diseases or neurological, psychiatric/social conditions that could affect study compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent
14. Known history of human immunodeficiency virus (HIV) infection
15. Known history of active tuberculosis (TB) or active syphilis
16. History of allogeneic organ transplantation or hematopoietic stem cell transplantation
17. Accompanied by uncontrolled third interstitial fluids requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc.
18. Known severe allergic reactions to other monoclonal antibodies or are allergic to any IBI318 formulation component
19. Female subjects who are pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI318 DL7	IBI318	-
IBI318 DL6	IBI318	-
IBI318 DL8b	IBI318	-
IBI318 DL1	IBI318	-
IBI318 DL2	IBI318	-
IBI318 DL3	IBI318	-
IBI318 DL8	IBI318	-
IBI318 DL7b	IBI318	-
IBI318 RP2D	IBI318	-
IBI318 DL5	IBI318	-
IBI318 DL4	IBI318	-

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing clinical and laboratory adverse events (AEs)	Up to 90 days post last dose
Number of all study participants who demonstrate a tumor response	up to 24 months
Number of participants experiencing dose-limiting toxicities (DLTs)	28 days within first dose in phase Ia

Secondary Outcome Measures

Name	Time	Method
The half-life (t1/2) of IBI318 in plasma	Up to 90 days post last dose
Positive rate of ADA and Nab	Up to 90 days post last dose
The area under the curve (AUC) of plasma concentration of drug against time after administration of IBI318	Up to 90 days post last dose
Time at which maximum concentration (Tmax) occurs for IBI318	Up to 90 days post last dose
Maximum concentration (Cmax) after first dose interval of IBI318	Up to 90 days post last dose

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, China