Study of IBI318 in Participants With Advanced Malignancies

Advanced Malignancy Clinical Trial

Official title:

To Evaluate the Safety, Tolerability, and Initial Efficacy of IBI318 in Patients With Advanced Malignancy, Multicenter, IA/IB Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875157
• Other study ID #: CIBI318A101
• Status: Completed
• Phase: Phase 1
• Start date: April 19, 2019
• Est. completion date: February 16, 2023

Study information

• Verified date: February 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 16, 2023
• Est. primary completion date: February 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Malignancy
• Neoplasms

Intervention

Biological:
• IBI318
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
• IBI318
1 mg intravenous infusion, C1D1 and afterwards Q2W
• IBI318
3 mg intravenous infusion, C1D1 and afterwards Q2W
• IBI318
10 mg intravenous infusion, C1D1 and afterwards Q2W
• IBI318
30 mg intravenous infusion, C1D1 and afterwards Q2W
• IBI318
100 mg intravenous infusion, C1D1 and afterwards Q2W
• IBI318
300 mg intravenous infusion, C1D1 and afterwards Q2W
• IBI318
600 mg intravenous infusion, C1D1 and afterwards Q2W
• IBI318
Intravenous infusion, C1D1 and afterwards Q3W
• IBI318
Intravenous infusion, C1D1 and afterwards Q3W
• IBI318
Intravenous infusion Q3W

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou

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	Number of participants experiencing dose-limiting toxicities (DLTs)		28 days within first dose in phase Ia
Primary	Number of participants experiencing clinical and laboratory adverse events (AEs)		Up to 90 days post last dose
Primary	Number of all study participants who demonstrate a tumor response		up to 24 months
Secondary	The area under the curve (AUC) of plasma concentration of drug against time after administration of IBI318		Up to 90 days post last dose
Secondary	Maximum concentration (Cmax) after first dose interval of IBI318		Up to 90 days post last dose
Secondary	Time at which maximum concentration (Tmax) occurs for IBI318		Up to 90 days post last dose
Secondary	The half-life (t1/2) of IBI318 in plasma		Up to 90 days post last dose
Secondary	Positive rate of ADA and Nab		Up to 90 days post last dose